Trial Outcomes & Findings for Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster (NCT NCT04091451)
NCT ID: NCT04091451
Last Updated: 2025-12-04
Results Overview
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1430 participants
Primary outcome timeframe
From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)
Results posted on
2025-12-04
Participant Flow
The study was conducted at 46 centers in 8 countries (Estonia, Finland, Hong Kong, Mexico, Panama, Russian Federation, Spain and United Kingdom).
A total of 1430 participants were enrolled into the study, of which 1426 participants received at least 1 dose of study treatment/vaccine (HZ/su or placebo) and were included in the Exposed Set.
Participant milestones
| Measure |
HZ/su Group
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Overall Study
STARTED
|
714
|
712
|
|
Overall Study
COMPLETED
|
646
|
640
|
|
Overall Study
NOT COMPLETED
|
68
|
72
|
Reasons for withdrawal
| Measure |
HZ/su Group
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
10
|
|
Overall Study
Lost to Follow-up
|
8
|
8
|
|
Overall Study
Protocol Violation
|
5
|
4
|
|
Overall Study
Withdrawal by Subject
|
21
|
27
|
|
Overall Study
Non-emergency unblinding/Non-compliance
|
15
|
18
|
|
Overall Study
Migrated/moved from the study area
|
3
|
5
|
|
Overall Study
Suspected HZ episode
|
1
|
0
|
Baseline Characteristics
Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster
Baseline characteristics by cohort
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
Total
n=1426 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.5 • n=9 Participants
|
64.1 Years
STANDARD_DEVIATION 8.8 • n=6 Participants
|
64.1 Years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
|
Sex: Female, Male
Female
|
430 Participants
n=9 Participants
|
434 Participants
n=6 Participants
|
864 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
284 Participants
n=9 Participants
|
278 Participants
n=6 Participants
|
562 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
80 Participants
n=9 Participants
|
77 Participants
n=6 Participants
|
157 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
634 Participants
n=9 Participants
|
635 Participants
n=6 Participants
|
1269 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)Population: The analysis was performed on the modified Exposed Set (mES), which excluded participants from the Exposed Set who were not administered 2 doses of the study treatment per protocol, or who developed a confirmed case of HZ prior to 30 days after the second vaccination.
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
Outcome measures
| Measure |
HZ/su Group
n=668 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=682 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
|
0.0 Cases per 1000 person-years
|
4.1 Cases per 1000 person-years
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered.
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included PCR and the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Incidence Rate of Confirmed HZ Cases
|
0.0 Cases per 1000 person-years
|
3.6 Cases per 1000 person-years
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration.
Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (\>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.
Outcome measures
| Measure |
HZ/su Group
n=697 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=697 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Erythema, post-vaccination at Day 1
|
164 Participants
|
5 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Erythema, post-vaccination at Day 1
|
8 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Pain, post-vaccination at Day 1
|
562 Participants
|
61 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Pain, post-vaccination at Day 1
|
49 Participants
|
2 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Pruritus, post-vaccination at Day 1
|
148 Participants
|
24 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Pruritus, post-vaccination at Day 1
|
4 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Swelling, post-vaccination at Day 1
|
91 Participants
|
1 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Swelling, post-vaccination at Day 1
|
3 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Erythema, post-vaccination at Month 2
|
164 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Erythema, post-vaccination at Month 2
|
14 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Pain, post-vaccination at Month 2
|
503 Participants
|
48 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Pain, post-vaccination at Month 2
|
48 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Pruritus, post-vaccination at Month 2
|
142 Participants
|
10 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Pruritus, post-vaccination at Month 2
|
7 Participants
|
0 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Any Swelling, post-vaccination at Month 2
|
82 Participants
|
1 Participants
|
|
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Grade 3 Swelling, post-vaccination at Month 2
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited administration site event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category.
Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.
Outcome measures
| Measure |
HZ/su Group
n=562 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=61 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Duration in Days of Solicited Administration Site Events
Pain, post-vaccination at Month 2
|
3.0 Days
Interval 2.0 to 4.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Administration Site Events
Pruritus, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Administration Site Events
Swelling, post-vaccination at Month 2
|
3.0 Days
Interval 2.0 to 4.0
|
6.0 Days
Interval 6.0 to 6.0
|
|
Duration in Days of Solicited Administration Site Events
Pruritus, post-vaccination at Day 1
|
2.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 3.0
|
|
Duration in Days of Solicited Administration Site Events
Swelling, post-vaccination at Day 1
|
3.0 Days
Interval 1.0 to 4.0
|
2.0 Days
Interval 2.0 to 2.0
|
|
Duration in Days of Solicited Administration Site Events
Erythema, post-vaccination at Month 2
|
3.0 Days
Interval 2.0 to 5.0
|
—
|
|
Duration in Days of Solicited Administration Site Events
Erythema, post-vaccination at Day 1
|
3.0 Days
Interval 2.0 to 5.0
|
3.0 Days
Interval 2.0 to 4.0
|
|
Duration in Days of Solicited Administration Site Events
Pain, post-vaccination at Day 1
|
3.0 Days
Interval 2.0 to 4.0
|
1.0 Days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration.
Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (\>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=698 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=697 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Headache, post-vaccination at Day 1
|
224 Participants
|
90 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Malaise, post-vaccination at Day 1
|
260 Participants
|
70 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Myalgia, post-vaccination at Day 1
|
17 Participants
|
8 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Myalgia, post-vaccination at Day 1
|
240 Participants
|
45 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Shivering, post-vaccination at Day 1
|
185 Participants
|
43 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Shivering, post-vaccination at Day 1
|
16 Participants
|
0 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Shivering, post-vaccination at Day 1
|
174 Participants
|
36 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Fatigue, post-vaccination at Month 2
|
364 Participants
|
115 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Fatigue, post-vaccination at Month 2
|
59 Participants
|
10 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Fatigue, post-vaccination at Month 2
|
327 Participants
|
85 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Fever, post-vaccination at Month 2
|
66 Participants
|
5 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Malaise, post-vaccination at Month 2
|
290 Participants
|
50 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Myalgia, post-vaccination at Month 2
|
294 Participants
|
54 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Shivering, post-vaccination at Month 2
|
253 Participants
|
32 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Shivering, post-vaccination at Month 2
|
37 Participants
|
2 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Fatigue, post-vaccination at Day 1
|
329 Participants
|
146 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Fatigue, post-vaccination at Day 1
|
42 Participants
|
10 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Fatigue, post-vaccination at Day 1
|
292 Participants
|
105 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Fever, post-vaccination at Day 1
|
26 Participants
|
4 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Fever, post-vaccination at Day 1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Fever, post-vaccination at Day 1
|
26 Participants
|
4 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Gastrointestinal symptoms, post-vaccination at Day 1
|
103 Participants
|
79 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Gastrointestinal symptoms, post-vaccination at Day 1
|
8 Participants
|
4 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Gastrointestinal symptoms, post-vaccination at Day 1
|
84 Participants
|
54 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Headache, post-vaccination at Day 1
|
266 Participants
|
136 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Headache, post-vaccination at Day 1
|
21 Participants
|
11 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Malaise, post-vaccination at Day 1
|
30 Participants
|
9 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Malaise, post-vaccination at Day 1
|
231 Participants
|
52 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Myalgia, post-vaccination at Day 1
|
262 Participants
|
65 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Fever, post-vaccination at Month 2
|
4 Participants
|
1 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Fever, post-vaccination at Month 2
|
63 Participants
|
3 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Gastrointestinal symptoms, post-vaccination at Month 2
|
118 Participants
|
54 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Gastrointestinal symptoms, post-vaccination at Month 2
|
11 Participants
|
4 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Gastrointestinal symptoms, post-vaccination at Month 2
|
102 Participants
|
37 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Headache, post-vaccination at Month 2
|
290 Participants
|
113 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Headache, post-vaccination at Month 2
|
30 Participants
|
6 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Headache, post-vaccination at Month 2
|
256 Participants
|
73 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Any Malaise, post-vaccination at Month 2
|
321 Participants
|
69 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Malaise, post-vaccination at Month 2
|
45 Participants
|
7 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Grade 3 Myalgia, post-vaccination at Month 2
|
41 Participants
|
2 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Myalgia, post-vaccination at Month 2
|
269 Participants
|
40 Participants
|
|
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Related Shivering, post-vaccination at Month 2
|
234 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccination (occurring at Day 1 and Month 2)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited systemic event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category.
Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature \>=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.
Outcome measures
| Measure |
HZ/su Group
n=364 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=146 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Duration in Days of Solicited Systemic Events
Myalgia, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 5.0
|
|
Duration in Days of Solicited Systemic Events
Shivering, post-vaccination at Month 2
|
1.0 Days
Interval 1.0 to 2.0
|
2.0 Days
Interval 1.0 to 3.0
|
|
Duration in Days of Solicited Systemic Events
Fatigue, post-vaccination at Day 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration in Days of Solicited Systemic Events
Fever, post-vaccination at Day 1
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Systemic Events
Gastrointestinal symptoms, post-vaccination at Day 1
|
1.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Systemic Events
Myalgia, post-vaccination at Day 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration in Days of Solicited Systemic Events
Shivering, post-vaccination at Day 1
|
1.0 Days
Interval 1.0 to 2.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Systemic Events
Fatigue, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration in Days of Solicited Systemic Events
Headache, post-vaccination at Day 1
|
2.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 3.0
|
|
Duration in Days of Solicited Systemic Events
Malaise, post-vaccination at Day 1
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
|
Duration in Days of Solicited Systemic Events
Fever, post-vaccination at Month 2
|
1.0 Days
Interval 1.0 to 1.0
|
1.0 Days
Interval 1.0 to 1.0
|
|
Duration in Days of Solicited Systemic Events
Gastrointestinal symptoms, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
1.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Systemic Events
Headache, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 2.0
|
|
Duration in Days of Solicited Systemic Events
Malaise, post-vaccination at Month 2
|
2.0 Days
Interval 1.0 to 3.0
|
2.0 Days
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Within 30 days after each vaccination (occurring at Day 1 and Month 2)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom unsolicited AEs data were available for the specified duration after each vaccination.
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any Unsolicited AEs, post-vaccination at Day 1
|
118 Participants
|
104 Participants
|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 Unsolicited AEs, post-vaccination at Day 1
|
12 Participants
|
10 Participants
|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related Unsolicited AEs, post-vaccination at Day 1
|
32 Participants
|
18 Participants
|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Any Unsolicited AEs, post-vaccination at Month 2
|
120 Participants
|
116 Participants
|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Grade 3 Unsolicited AEs, post-vaccination at Month 2
|
13 Participants
|
6 Participants
|
|
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Related Unsolicited AEs, post-vaccination at Month 2
|
33 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Any SAEs
|
11 Participants
|
11 Participants
|
|
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Related SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom pIMDs data were available for the specified duration.
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)
Related pIMDs
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)
Any pIMDs
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any and Related SAEs
Any SAEs
|
35 Participants
|
22 Participants
|
|
Number of Participants With Any and Related SAEs
Related SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom pIMDs data were available for the specified duration.
pIMDs are defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With Any and Related pIMDs
Related pIMDs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any and Related pIMDs
Any pIMDs
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)Population: The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs related to investigational vaccine/study participation/GSK concomitant medication/vaccine data were available for the specified duration.
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.
Outcome measures
| Measure |
HZ/su Group
n=714 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Month 2 and Month 3Population: The analysis was performed on the Adapted Per Protocol Set for immunogenicity, which included all evaluable participants from the Exposed Set who met all eligibility criteria, received 2 doses of the HZ/su vaccine/placebo according to their random assignment, did not receive forbidden medications, had no intercurrent medical condition complied with the vaccination and blood sample schedules and for whom results were available for the specified analysis at the specified time points.
Vaccine response for anti-gE antibodies is defined as: * For initially seronegative participants, anti-gE antibody concentration at post-vaccination \>= 4-fold the cut-off value for anti-gE \[97 international units per liter (IU/L)\]. * For initially seropositive participants, anti-gE antibody concentration at post-vaccination \>= 4-fold the pre-vaccination anti-gE antibody concentration.
Outcome measures
| Measure |
HZ/su Group
n=593 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=592 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)
At Month 2
|
85.8 Percentage of participants
Interval 82.8 to 88.5
|
0.2 Percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)
At Month 3
|
95.3 Percentage of participants
Interval 93.1 to 96.9
|
0.2 Percentage of participants
Interval 0.0 to 1.1
|
SECONDARY outcome
Timeframe: At Day 1, Month 2 and Month 3Population: The analysis was performed on the Adapted Per Protocol Set for immunogenicity, which included all evaluable participants from the Exposed Set who met all eligibility criteria, received 2 doses of the HZ/su vaccine/placebo according to their random assignment, did not receive forbidden medications, had no intercurrent medical condition complied with the vaccination and blood sample schedules and for whom results were available for the specified analysis at the specified time points.
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.
Outcome measures
| Measure |
HZ/su Group
n=664 Participants
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=658 Participants
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA
At Month 3
|
49175.78 IU/L
Interval 46500.4 to 52005.09
|
1849.08 IU/L
Interval 1718.02 to 1990.13
|
|
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA
At Day 1
|
2151.30 IU/L
Interval 2004.22 to 2309.17
|
2087.14 IU/L
Interval 1942.47 to 2242.58
|
|
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA
At Month 2
|
24346.52 IU/L
Interval 22840.59 to 25951.74
|
1850.11 IU/L
Interval 1725.86 to 1983.3
|
Adverse Events
HZ/su Group
Serious events: 56 serious events
Other events: 665 other events
Deaths: 12 deaths
Placebo Group
Serious events: 43 serious events
Other events: 414 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
HZ/su Group
n=714 participants at risk
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 participants at risk
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Angina unstable
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Cardiac failure
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Cardiac failure acute
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Palpitations
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Cataract
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Iritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Retinal detachment
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Ileus
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
COVID-19
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.56%
4/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Cellulitis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Diverticulitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Erysipelas
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Neurosyphilis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pneumonia
|
0.56%
4/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pyelonephritis acute
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Respiratory tract infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Septic shock
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Urinary tract infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Vestibular neuronitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Costal cartilage fracture
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Wound
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Syncope
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Completed suicide
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Hallucination
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Peripheral ischaemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
Other adverse events
| Measure |
HZ/su Group
n=714 participants at risk
Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2.
|
Placebo Group
n=712 participants at risk
Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2.
|
|---|---|---|
|
General disorders
Administration site pain
|
85.6%
611/714 • Number of events 1065 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
13.2%
94/712 • Number of events 109 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Fatigue
|
64.0%
457/714 • Number of events 695 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
27.9%
199/712 • Number of events 262 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Malaise
|
55.5%
396/714 • Number of events 584 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
15.7%
112/712 • Number of events 139 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Chills
|
46.2%
330/714 • Number of events 440 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
9.0%
64/712 • Number of events 76 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Administration site erythema
|
33.3%
238/714 • Number of events 328 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Administration site swelling
|
18.6%
133/714 • Number of events 173 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Pyrexia
|
12.3%
88/714 • Number of events 94 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
1.4%
10/712 • Number of events 10 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site bruising
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Asthenia
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Feeling hot
|
0.14%
1/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Influenza like illness
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site rash
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Pain
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Swelling
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Discomfort
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Feeling cold
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Illness
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site erythema
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site hypoaesthesia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site joint pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site pruritus
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Injection site warmth
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Medical device pain
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Peripheral swelling
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Temperature regulation disorder
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Vaccination site movement impairment
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Vaccination site pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Vaccination site scar
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
General disorders
Vessel puncture site bruise
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Headache
|
53.8%
384/714 • Number of events 573 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
28.2%
201/712 • Number of events 270 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Dizziness
|
0.70%
5/714 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Paraesthesia
|
0.42%
3/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.56%
4/712 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Migraine
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Burning sensation
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Hyperaesthesia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Lethargy
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Polyneuropathy
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Sinus headache
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Syncope
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Nervous system disorders
Tremor
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
54.5%
389/714 • Number of events 560 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
13.6%
97/712 • Number of events 122 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
23/714 • Number of events 24 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
1.1%
8/712 • Number of events 9 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.98%
7/714 • Number of events 7 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.56%
4/712 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.84%
6/714 • Number of events 6 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 6 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.56%
4/714 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.28%
2/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
25.1%
179/714 • Number of events 221 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
16.4%
117/712 • Number of events 134 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.42%
3/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.56%
4/712 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Odynophagia
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Toothache
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Dental caries
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Diverticulum
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Dry mouth
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Gingival pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Gastrointestinal disorders
Stomatitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
31.9%
228/714 • Number of events 297 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
4.6%
33/712 • Number of events 41 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
10/714 • Number of events 11 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.84%
6/714 • Number of events 6 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.14%
1/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
18/714 • Number of events 19 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
2.2%
16/712 • Number of events 19 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
COVID-19
|
1.1%
8/714 • Number of events 8 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
1.1%
8/712 • Number of events 8 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Oral herpes
|
1.3%
9/714 • Number of events 9 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.84%
6/712 • Number of events 6 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Urinary tract infection
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 5 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Influenza
|
0.56%
4/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Sinusitis
|
0.28%
2/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Conjunctivitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Otitis externa
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Acute sinusitis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Cystitis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Herpes simplex
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Ear infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Gastroenteritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Respiratory tract infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Suspected COVID-19
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Tinea pedis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Viral infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Abdominal infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Abscess
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Anal abscess
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Bartholinitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Bronchitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Candida infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Erysipelas
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Eye infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Folliculitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Furuncle
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Herpes zoster
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Impetigo
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pharyngitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pneumonia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Postoperative wound infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Pustule
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Tooth abscess
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Vaginal infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Infections and infestations
Wound infection
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.98%
7/714 • Number of events 7 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.70%
5/712 • Number of events 7 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.42%
3/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
1.1%
8/712 • Number of events 8 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.28%
2/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal disorder
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Fall
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Accident
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Bite
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.14%
1/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Insomnia
|
0.28%
2/714 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Anxiety
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Depression
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Middle insomnia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Panic disorder
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Persistent depressive disorder
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Sleep disorder
|
0.14%
1/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Hypertension
|
0.56%
4/714 • Number of events 4 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Hypertensive crisis
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Haematoma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Hot flush
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Intermittent claudication
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Peripheral coldness
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Dry eye
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Vitreous detachment
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Cataract
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Erythema of eyelid
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Eye pain
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Eye swelling
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Iritis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Vision blurred
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Eye disorders
Visual impairment
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Gout
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Palpitations
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Arrhythmia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Cardiac disorders
Tachycardia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.42%
3/712 • Number of events 3 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Bladder discomfort
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Micturition urgency
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Renal and urinary disorders
Pollakiuria
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Ear and labyrinth disorders
Vertigo
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Immune system disorders
Seasonal allergy
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Immune system disorders
Hypersensitivity
|
0.28%
2/714 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.28%
2/712 • Number of events 2 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Blood and lymphatic system disorders
Splenic lesion
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Investigations
Blood pressure increased
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Investigations
Body temperature increased
|
0.14%
1/714 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.00%
0/712 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Congenital, familial and genetic disorders
Haemangioma congenital
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/714 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
0.14%
1/712 • Number of events 1 • Solicited AEs: within 7 days after any vaccination. Unsolicited AEs: within 30 days after any vaccination. All-cause mortality & SAEs: from first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months). pIMDs: from first vaccination (Day 1) until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses).
All events presented in the All-cause mortality, Serious Adverse Events and Other (not including Serious) Adverse Events modules are reported for the Exposed Set population during the specified time frames. All SAEs regardless of relation to study vaccine/study participation/GSK concomitant medication/vaccination are reported in the Serious Adverse Events module.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER