Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001) (NCT NCT01229267)
NCT ID: NCT01229267
Last Updated: 2019-09-30
Results Overview
Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1257 participants
Primary outcome timeframe
Up to approximately 5 years
Results posted on
2019-09-30
Participant Flow
Adult participants scheduled to undergo Autologous Hematopoietic Cell Transplant (auto-HCT) within 60 days were enrolled at 150 sties
A total of 1323 participants were screened and 1257 were randomized. Twenty-seven randomized participants were removed from all analyses due to the identification of major Good Clinical Practice compliance issues at a single site.
Participant milestones
| Measure |
V212 Consistency Lot 1
Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 2
Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 3
Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 High Antigen Lot
Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
189
|
184
|
187
|
106
|
564
|
|
Overall Study
Received Vaccination 1
|
188
|
180
|
186
|
104
|
556
|
|
Overall Study
Received Vaccination 2
|
171
|
163
|
168
|
94
|
511
|
|
Overall Study
Received Vaccination 3
|
163
|
155
|
160
|
89
|
491
|
|
Overall Study
Received Vaccination 4
|
155
|
149
|
149
|
87
|
477
|
|
Overall Study
COMPLETED
|
108
|
102
|
101
|
71
|
344
|
|
Overall Study
NOT COMPLETED
|
81
|
82
|
86
|
35
|
220
|
Reasons for withdrawal
| Measure |
V212 Consistency Lot 1
Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 2
Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 3
Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 High Antigen Lot
Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
3
|
2
|
10
|
|
Overall Study
Death
|
40
|
37
|
35
|
13
|
103
|
|
Overall Study
Withdrawal by Subject
|
23
|
22
|
32
|
14
|
59
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Progressive disease
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
8
|
11
|
8
|
3
|
25
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
8
|
3
|
22
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
Baseline characteristics by cohort
| Measure |
V212 Consistency Lot 1
n=189 Participants
Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 2
n=184 Participants
Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 Consistency Lot 3
n=187 Participants
Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
V212 High Antigen Lot
n=106 Participants
Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=564 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Total
n=1230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 12.8 • n=99 Participants
|
54.2 Years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
53.4 Years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
54.3 Years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
54.1 Years
STANDARD_DEVIATION 12.2 • n=31 Participants
|
54.1 Years
STANDARD_DEVIATION 12.4 • n=30 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
204 Participants
n=31 Participants
|
455 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
360 Participants
n=31 Participants
|
775 Participants
n=30 Participants
|
|
Age categorical
From 18-49 years
|
53 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
159 Participants
n=31 Participants
|
346 Participants
n=30 Participants
|
|
Age categorical
From 50-59 years
|
56 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
187 Participants
n=31 Participants
|
407 Participants
n=30 Participants
|
|
Age categorical
From 60-69 years
|
63 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
188 Participants
n=31 Participants
|
408 Participants
n=30 Participants
|
|
Age categorical
From 70-79 years
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
69 Participants
n=30 Participants
|
|
Intended duration of antiviral prophylaxis
≤3 months post auto-HCT
|
80 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
255 Participants
n=31 Participants
|
537 Participants
n=30 Participants
|
|
Intended duration of antiviral prophylaxis
>3 to ≤6 months post auto-HCT
|
109 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
308 Participants
n=31 Participants
|
691 Participants
n=30 Participants
|
|
Intended duration of antiviral prophylaxis
Not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 5 yearsPopulation: The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.
Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.
Outcome measures
| Measure |
V212 Consistency Lots
n=538 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=535 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Incidence of Confirmed Herpes-Zoster
|
32.889 Number of cases per 1000 person years
Interval 23.703 to 44.456
|
91.883 Number of cases per 1000 person years
Interval 75.725 to 110.469
|
PRIMARY outcome
Timeframe: Up to 28 days after vaccination 4 (up to 118 days)Population: The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Outcome measures
| Measure |
V212 Consistency Lots
n=657 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=554 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Percentage of Participants With One or More Serious Adverse Events
|
32.9 Percentage of participants
|
32.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 6 months after onset of HZ (up to approximately 5 years)Population: The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.
Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.
Outcome measures
| Measure |
V212 Consistency Lots
n=538 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=535 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Incidence of Moderate to Severe Herpes-Zoster-Associated Pain
|
14.878 Number of cases per 1000 person years
Interval 8.958 to 23.234
|
49.601 Number of cases per 1000 person years
Interval 37.941 to 63.714
|
SECONDARY outcome
Timeframe: Up to 6 months after onset of HZ (up to approximately 5 years)Population: The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.
The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.
Outcome measures
| Measure |
V212 Consistency Lots
n=538 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=535 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Incidence of Herpes-Zoster Complications
|
9.397 Number of cases per 1000 person years
Interval 4.855 to 16.414
|
35.777 Number of cases per 1000 person years
Interval 25.996 to 48.03
|
SECONDARY outcome
Timeframe: Up to 6 months after the onset of HZ rash (up to approximately 5 years)Population: The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.
Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.
Outcome measures
| Measure |
V212 Consistency Lots
n=538 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=535 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Incidence of Postherpetic Neuralgia
|
2.349 Number of cases per 1000 person years
Interval 0.484 to 6.865
|
14.636 Number of cases per 1000 person years
Interval 8.674 to 23.132
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 28 days after vaccination 4 (up to 118 days)Population: The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Outcome measures
| Measure |
V212 Consistency Lots
n=657 Participants
Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=554 Participants
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event
|
3.0 Percentage of participants
|
3.1 Percentage of participants
|
Adverse Events
V212 [Including High Antigen Lot]
Serious events: 420 serious events
Other events: 625 other events
Deaths: 136 deaths
Placebo
Serious events: 374 serious events
Other events: 512 other events
Deaths: 107 deaths
Serious adverse events
| Measure |
V212 [Including High Antigen Lot]
n=657 participants at risk
Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=554 participants at risk
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Infections and infestations
Clostridium difficile colitis
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Clostridium difficile infection
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Acquired haemophilia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.4%
42/657 • Number of events 44 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.9%
38/554 • Number of events 47 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
8/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.3%
7/554 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Arrhythmia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Atrial fibrillation
|
0.61%
4/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Atrial flutter
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Bradycardia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac failure
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac failure acute
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Coronary artery disease
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Pericarditis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Eye disorders
Diabetic retinopathy
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Eye disorders
Intraocular haematoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Ascites
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Colitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
7/657 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.7%
15/554 • Number of events 16 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Dyskinesia oesophageal
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Dysphagia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Faecaloma
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Mesenteritis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Adverse drug reaction
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Asthenia
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Death
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Drug withdrawal syndrome
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
General physical health deterioration
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Influenza like illness
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Malaise
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Mucosal inflammation
|
1.2%
8/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.1%
6/554 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Pneumatosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Pyrexia
|
5.0%
33/657 • Number of events 37 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
4.7%
26/554 • Number of events 26 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Cholangitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.15%
1/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Drug hypersensitivity
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Engraftment syndrome
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Graft versus host disease in liver
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Graft versus host disease in lung
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Hypersensitivity
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Immune system disorders
Primary amyloidosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Abdominal abscess
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Actinomycotic pulmonary infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Acute sinusitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Appendicitis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Appendicitis perforated
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Aspergilloma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Aspergillus infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Atypical pneumonia
|
0.91%
6/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
BK virus infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bacteraemia
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.3%
7/554 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bronchiolitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bronchitis
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bronchitis viral
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.91%
6/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Candida sepsis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cellulitis
|
0.61%
4/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Chronic hepatitis B
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Clostridial infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Clostridium colitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Coxsackie viral infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cystitis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Cytomegalovirus oesophagitis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Dengue fever
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Device related infection
|
0.76%
5/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Device related sepsis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Diverticulitis
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Empyema
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Enterococcal infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Enterovirus infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Epididymitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Erysipelas
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Escherichia sepsis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Febrile infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Fungal oesophagitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Gastroenteritis
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Gastroenteritis viral
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Groin abscess
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Herpes zoster
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.2%
12/554 • Number of events 12 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Infected lymphocele
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Infection in an immunocompromised host
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.15%
1/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Influenza
|
1.2%
8/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.3%
7/554 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Klebsiella infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
1/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Lung abscess
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Lung infection
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Meningitis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Meningitis pneumococcal
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Neutropenic sepsis
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Oral candidiasis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pharyngitis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia
|
9.3%
61/657 • Number of events 74 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
10.1%
56/554 • Number of events 67 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia bacterial
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pneumonia viral
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Postoperative abscess
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Postoperative wound infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pulmonary mycosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pulmonary sepsis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Retinitis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Scrotal abscess
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Sepsis
|
2.9%
19/657 • Number of events 19 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.2%
12/554 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Sepsis syndrome
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Septic shock
|
1.1%
7/657 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Sialoadenitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Sinusitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Staphylococcal infection
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Systemic candida
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Tuberculosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
8/657 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Varicella
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Viral infection
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Viral sepsis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Delayed engraftment
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Investigations
Transaminases increased
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.30%
2/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Tetany
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large cell lymphoma T- and null-cell types
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large cell lymphoma T- and null-cell types recurrent
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large-cell lymphoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiocentric lymphoma
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-cell lymphoma recurrent
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma recurrent
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage IV
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.15%
1/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia recurrent
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
1.5%
10/657 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.8%
10/554 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma recurrent
|
2.1%
14/657 • Number of events 14 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.8%
10/554 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma refractory
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III recurrent
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
1.2%
8/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease nodular sclerosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease recurrent
|
1.1%
7/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.1%
6/554 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.4%
9/657 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.1%
6/554 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoplasmacytoid lymphoma/immunocytoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant lymphoid neoplasm
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma recurrent
|
1.5%
10/657 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.6%
9/554 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.91%
6/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
1.5%
10/657 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.3%
13/554 • Number of events 13 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma refractory
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nonkeratinising carcinoma of nasopharynx
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peripheral T-cell lymphoma unspecified recurrent
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
10.2%
67/657 • Number of events 75 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
9.2%
51/554 • Number of events 57 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
7.6%
50/657 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
9.6%
53/554 • Number of events 56 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precursor T-lymphoblastic lymphoma/leukaemia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Precursor T-lymphoblastic lymphoma/leukaemia recurrent
|
0.15%
1/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary mediastinal large B-cell lymphoma
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
1.2%
8/657 • Number of events 8 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Carotid artery disease
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Cerebellar infarction
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.61%
4/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Dizziness
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Headache
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Migraine
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Paraesthesia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Sciatica
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Syncope
|
0.91%
6/657 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Pregnancy, puerperium and perinatal conditions
Threatened labour
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Anxiety
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Delirium
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Depression
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Disorientation
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Mania
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Mental status changes
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Suicide attempt
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
8/657 • Number of events 10 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.8%
10/554 • Number of events 11 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
End stage renal disease
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Haematuria
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
4/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.91%
6/657 • Number of events 6 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.90%
5/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.46%
3/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.46%
3/657 • Number of events 4 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.46%
3/657 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Aortic aneurysm
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Aortic stenosis
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
7/657 • Number of events 7 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.36%
2/554 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Embolism
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Hypertension
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Hypotension
|
0.76%
5/657 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.54%
3/554 • Number of events 3 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Orthostatic hypotension
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.15%
1/657 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Venoocclusive disease
|
0.30%
2/657 • Number of events 2 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.00%
0/554 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/657 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.18%
1/554 • Number of events 1 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
Other adverse events
| Measure |
V212 [Including High Antigen Lot]
n=657 participants at risk
Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.
|
Placebo
n=554 participants at risk
Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
26.6%
175/657 • Number of events 201 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
24.2%
134/554 • Number of events 168 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.0%
184/657 • Number of events 191 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
24.4%
135/554 • Number of events 138 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.0%
33/657 • Number of events 34 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
5.8%
32/554 • Number of events 41 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
24.8%
163/657 • Number of events 187 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
23.3%
129/554 • Number of events 157 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
9.6%
63/657 • Number of events 64 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
9.6%
53/554 • Number of events 54 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
36.2%
238/657 • Number of events 289 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
38.3%
212/554 • Number of events 264 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Cardiac disorders
Tachycardia
|
6.8%
45/657 • Number of events 47 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.1%
34/554 • Number of events 35 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.2%
87/657 • Number of events 103 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
14.1%
78/554 • Number of events 81 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.8%
51/657 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.1%
34/554 • Number of events 35 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Constipation
|
16.3%
107/657 • Number of events 120 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
18.4%
102/554 • Number of events 113 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
60.0%
394/657 • Number of events 492 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
61.6%
341/554 • Number of events 396 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
61/657 • Number of events 65 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
8.5%
47/554 • Number of events 52 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Nausea
|
56.3%
370/657 • Number of events 452 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
57.6%
319/554 • Number of events 391 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
12.6%
83/657 • Number of events 94 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
9.2%
51/554 • Number of events 56 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
211/657 • Number of events 265 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
36.1%
200/554 • Number of events 260 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Asthenia
|
11.0%
72/657 • Number of events 77 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
10.8%
60/554 • Number of events 68 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Chills
|
5.9%
39/657 • Number of events 44 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.3%
35/554 • Number of events 42 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Fatigue
|
21.9%
144/657 • Number of events 159 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
21.8%
121/554 • Number of events 131 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Injection site erythema
|
23.3%
153/657 • Number of events 323 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.5%
14/554 • Number of events 19 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Injection site pain
|
20.2%
133/657 • Number of events 283 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
3.8%
21/554 • Number of events 24 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Injection site pruritus
|
5.3%
35/657 • Number of events 52 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
0.72%
4/554 • Number of events 5 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Injection site swelling
|
18.9%
124/657 • Number of events 257 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
1.6%
9/554 • Number of events 9 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Mucosal inflammation
|
38.7%
254/657 • Number of events 271 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
40.8%
226/554 • Number of events 244 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Oedema peripheral
|
11.7%
77/657 • Number of events 89 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
11.7%
65/554 • Number of events 72 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
General disorders
Pyrexia
|
48.2%
317/657 • Number of events 526 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
44.8%
248/554 • Number of events 374 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
152/657 • Number of events 161 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
23.8%
132/554 • Number of events 150 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
33/657 • Number of events 40 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
2.9%
16/554 • Number of events 16 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.4%
55/657 • Number of events 65 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
7.2%
40/554 • Number of events 45 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.5%
141/657 • Number of events 165 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
20.0%
111/554 • Number of events 135 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.6%
76/657 • Number of events 88 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
11.2%
62/554 • Number of events 75 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.2%
41/657 • Number of events 48 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
7.2%
40/554 • Number of events 42 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
56/657 • Number of events 63 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
8.3%
46/554 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
33/657 • Number of events 35 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
4.3%
24/554 • Number of events 26 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Dizziness
|
6.7%
44/657 • Number of events 46 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
8.3%
46/554 • Number of events 51 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Dysgeusia
|
4.4%
29/657 • Number of events 29 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
5.1%
28/554 • Number of events 28 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Nervous system disorders
Headache
|
19.9%
131/657 • Number of events 149 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
20.6%
114/554 • Number of events 141 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Anxiety
|
5.3%
35/657 • Number of events 38 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
5.6%
31/554 • Number of events 32 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Psychiatric disorders
Insomnia
|
12.8%
84/657 • Number of events 91 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
12.3%
68/554 • Number of events 71 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.6%
76/657 • Number of events 84 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
14.4%
80/554 • Number of events 93 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.4%
55/657 • Number of events 60 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.5%
36/554 • Number of events 36 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
41/657 • Number of events 48 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
4.3%
24/554 • Number of events 26 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.4%
68/657 • Number of events 78 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
7.8%
43/554 • Number of events 48 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
33/657 • Number of events 37 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
4.0%
22/554 • Number of events 31 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
66/657 • Number of events 72 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.9%
38/554 • Number of events 45 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.5%
89/657 • Number of events 110 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
13.4%
74/554 • Number of events 84 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Hypertension
|
5.0%
33/657 • Number of events 38 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
6.0%
33/554 • Number of events 36 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
|
Vascular disorders
Hypotension
|
8.7%
57/657 • Number of events 64 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
8.7%
48/554 • Number of events 52 • Adverse events were collected up to approximately 5 years after vaccination 1.
The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER