Trial Outcomes & Findings for Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (NCT NCT03621670)
NCT ID: NCT03621670
Last Updated: 2026-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1196 participants
Primary outcome timeframe
Day 301 to Day 307
Results posted on
2026-02-10
Participant Flow
Out of the 1196 participants enrolled, only 1184 participants were included in the Exposed Set and started the study.
Participant milestones
| Measure |
MenB+PCV Group
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Overall Study
STARTED
|
781
|
403
|
|
Overall Study
COMPLETED
|
642
|
326
|
|
Overall Study
NOT COMPLETED
|
139
|
77
|
Reasons for withdrawal
| Measure |
MenB+PCV Group
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
32
|
25
|
|
Overall Study
Consent withdrawal not due to AEs
|
54
|
18
|
|
Overall Study
Migrated / Moved from the study area
|
21
|
12
|
|
Overall Study
Not willing / Not able to be contacted
|
9
|
13
|
|
Overall Study
Other
|
13
|
5
|
|
Overall Study
Protocol Deviation
|
7
|
3
|
Baseline Characteristics
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
Baseline characteristics by cohort
| Measure |
MenB+PCV Group
n=781 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=403 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
Total
n=1184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.6 Weeks
STANDARD_DEVIATION 1.0 • n=41 Participants
|
8.8 Weeks
STANDARD_DEVIATION 1.0 • n=1581 Participants
|
8.7 Weeks
STANDARD_DEVIATION 1.0 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
380 Participants
n=41 Participants
|
196 Participants
n=1581 Participants
|
576 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
401 Participants
n=41 Participants
|
207 Participants
n=1581 Participants
|
608 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
17 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=41 Participants
|
21 Participants
n=1581 Participants
|
60 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
84 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
117 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
4 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
White
|
531 Participants
n=41 Participants
|
288 Participants
n=1581 Participants
|
819 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Other (Not specified)
|
107 Participants
n=41 Participants
|
56 Participants
n=1581 Participants
|
163 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the Solicited Safety Set, which included all participants who received a study vaccination and had solicited adverse event data available for the specified duration.
Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.
Outcome measures
| Measure |
MenB+PCV Group
n=768 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=394 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Erythema, Bexsero
|
156 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Erythema, Prevnar 13
|
100 Participants
|
39 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Erythema, Placebo
|
—
|
25 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Erythema, Pediarix
|
72 Participants
|
32 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Erythema, Hiberix
|
74 Participants
|
17 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Induration, Bexsero
|
204 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Induration, Prevnar 13
|
127 Participants
|
67 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Induration, Placebo
|
—
|
22 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Induration, Pediarix
|
70 Participants
|
34 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Induration, Hiberix
|
77 Participants
|
20 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Swelling, Bexsero
|
132 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Swelling, Prevnar 13
|
77 Participants
|
34 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Swelling, Placebo
|
—
|
21 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Swelling, Pediarix
|
53 Participants
|
21 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Swelling, Hiberix
|
54 Participants
|
12 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Tenderness, Bexsero
|
352 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Tenderness, Prevnar 13
|
310 Participants
|
107 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Tenderness, Placebo
|
0 Participants
|
81 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Tenderness, Pediarix
|
270 Participants
|
92 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Tenderness, Hiberix
|
284 Participants
|
74 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
MenB+PCV Group
n=768 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=394 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Change in eating habits
|
329 Participants
|
122 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Diarrhea
|
173 Participants
|
84 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Irritability
|
601 Participants
|
242 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Persistent crying
|
248 Participants
|
89 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Sleepiness
|
560 Participants
|
246 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Vomiting
|
176 Participants
|
79 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Fever
|
252 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: Day 61 to Day 67Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Rotarix was administered orally; therefore, no administration site events were analyzed.
Outcome measures
| Measure |
MenB+PCV Group
n=699 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=364 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Induration, Pediarix
|
109 Participants
|
55 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Induration, Hiberix
|
80 Participants
|
32 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Swelling, Bexsero
|
112 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Swelling, Prevnar 13
|
74 Participants
|
38 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Swelling, Placebo
|
—
|
19 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Swelling, Pediarix
|
52 Participants
|
33 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Tenderness, Bexsero
|
269 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Swelling, Hiberix
|
49 Participants
|
17 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Tenderness, Prevnar 13
|
227 Participants
|
81 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Tenderness, Placebo
|
0 Participants
|
65 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Tenderness, Pediarix
|
201 Participants
|
67 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Tenderness, Hiberix
|
207 Participants
|
52 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Erythema, Bexsero
|
200 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Erythema, Prevnar 13
|
129 Participants
|
62 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Erythema, Placebo
|
—
|
44 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Erythema, Pediarix
|
99 Participants
|
54 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Erythema, Hiberix
|
86 Participants
|
41 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Induration, Bexsero
|
213 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Induration, Prevnar 13
|
142 Participants
|
63 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Induration, Placebo
|
—
|
32 Participants
|
PRIMARY outcome
Timeframe: Day 61 to Day 67Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=699 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=364 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Change in eating habits
|
238 Participants
|
90 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Diarrhea
|
119 Participants
|
66 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Irritability
|
514 Participants
|
215 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Persistent crying
|
209 Participants
|
73 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Sleepiness
|
455 Participants
|
183 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Vomiting
|
104 Participants
|
49 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Fever
|
269 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: Day 121 to Day 127Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=676 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=352 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Erythema, Bexsero
|
181 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Erythema, Prevnar 13
|
127 Participants
|
71 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Erythema, Placebo
|
—
|
43 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Erythema, Pediarix
|
114 Participants
|
65 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Erythema, Hiberix
|
97 Participants
|
38 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Induration, Bexsero
|
187 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Induration, Prevnar 13
|
128 Participants
|
60 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Induration, Placebo
|
—
|
26 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Induration, Pediarix
|
124 Participants
|
70 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Induration, Hiberix
|
86 Participants
|
28 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Swelling, Bexsero
|
103 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Swelling, Prevnar 13
|
67 Participants
|
39 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Swelling, Placebo
|
—
|
13 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Swelling, Pediarix
|
55 Participants
|
28 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Swelling, Hiberix
|
36 Participants
|
8 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Tenderness, Bexsero
|
244 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Tenderness, Prevnar 13
|
210 Participants
|
66 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Tenderness, Placebo
|
—
|
52 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Tenderness, Pediarix
|
188 Participants
|
58 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Tenderness, Hiberix
|
194 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: Day 121 to Day 127Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=676 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=352 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Change in eating habits
|
205 Participants
|
94 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Diarrhea
|
87 Participants
|
44 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Irritability
|
454 Participants
|
179 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Persistent crying
|
151 Participants
|
59 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Sleepiness
|
326 Participants
|
142 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Vomiting
|
88 Participants
|
46 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Fever
|
216 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: Day 301 to Day 307Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=579 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=299 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Erythema, Bexsero
|
180 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Erythema, Prevnar 13/20
|
119 Participants
|
37 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Erythema, Placebo
|
—
|
25 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Erythema, MMR II
|
64 Participants
|
24 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Erythema, Varivax
|
62 Participants
|
20 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Induration, Bexsero
|
179 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Induration, Prevnar 13/20
|
109 Participants
|
32 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Induration, Placebo
|
—
|
24 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Induration, MMR II
|
46 Participants
|
17 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Induration, Varivax
|
38 Participants
|
15 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Swelling, Bexsero
|
91 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Swelling, Prevnar 13/20
|
52 Participants
|
18 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Swelling, Placebo
|
—
|
8 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Swelling, MMR II
|
26 Participants
|
12 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Swelling, Varivax
|
23 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Tenderness, Bexsero
|
223 Participants
|
—
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Tenderness, Prevnar 13/20
|
181 Participants
|
35 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Tenderness, Placebo
|
—
|
31 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Tenderness, MMR II
|
130 Participants
|
28 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Tenderness, Varivax
|
119 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Day 301 to Day 307Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=614 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=314 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Change in eating habits
|
219 Participants
|
75 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Diarrhea
|
85 Participants
|
40 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Irritability
|
401 Participants
|
153 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Persistent crying
|
115 Participants
|
29 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Rash
|
71 Participants
|
30 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Sleepiness
|
273 Participants
|
96 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Vomiting
|
60 Participants
|
32 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Fever
|
118 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Day 301 to Day 330Population: Analysis was performed on the Solicited Safety Set. Only participants with solicited adverse event data available for the specified duration were included in this analysis.
Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
MenB+PCV Group
n=627 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=321 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301
Parotid/Salivary gland swelling
|
20 Participants
|
17 Participants
|
|
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301
Rash
|
206 Participants
|
95 Participants
|
|
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301
Fever
|
197 Participants
|
70 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 30Population: Analysis was performed on the Unsolicited Safety Set, which included all participants who received a study vaccination and had unsolicited adverse event data available for the specified duration
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.
Outcome measures
| Measure |
MenB+PCV Group
n=775 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=401 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered at Day 1
|
214 Participants
|
103 Participants
|
PRIMARY outcome
Timeframe: Day 61 to Day 90Population: Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=745 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=388 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered at Day 61
|
225 Participants
|
119 Participants
|
PRIMARY outcome
Timeframe: Day 121 to Day 150Population: Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=725 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=374 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Unsolicted AEs After the Third Vaccination Administered at Day 121
|
230 Participants
|
120 Participants
|
PRIMARY outcome
Timeframe: Day 301 to Day 330Population: Analysis was performed on the Unsolicited Safety Set. Only participants with unsolicited adverse event data available for the specified duration were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=668 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=339 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs After the Fourth Vaccination Administered at Day 301
|
248 Participants
|
144 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to study end (Day 481 for participants who have not reached 6-month follow-up at the time of Protocol Amendment 7; Day 661 for all others)Population: Analysis was performed on the Unsolicited Safety Set. Only participants with data available at the specified timepoints were included in this analysis.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Outcome measures
| Measure |
MenB+PCV Group
n=775 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=401 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
AEs leading to withdrawal
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
SAEs
|
35 Participants
|
19 Participants
|
|
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
AESIs
|
6 Participants
|
3 Participants
|
|
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
MAAEs
|
375 Participants
|
177 Participants
|
PRIMARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the Per Protocol Set (PPS) for immunogenicity, which included all participants who received a study vaccination and provided immunogenicity data at one month after their third vaccination for at least 1 strain. Only participants with data available for the specified analysis at the specified timepoint were included.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=553 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
M14459 (fHbp)
|
92.2 Percentage of participants
Interval 88.6 to 94.9
|
—
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
96217 (NadA)
|
99.4 Percentage of participants
Interval 97.9 to 99.9
|
—
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
NZ98/254 (PorA)
|
73.5 Percentage of participants
Interval 68.2 to 78.3
|
—
|
|
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
M13520 (NHBA)
|
53.0 Percentage of participants
Interval 47.3 to 58.6
|
—
|
PRIMARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=524 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Titers >= LLOQ Against All Serogroup B Test Strains Combined (Composite Response)
|
42.7 Percentage of participants
Interval 37.0 to 48.6
|
—
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=505 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
96217 (NadA)
|
99.6 Percentage of participants
Interval 98.5 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
M14459 (fHbp)
|
89.0 Percentage of participants
Interval 85.8 to 91.7
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
NZ98/254 (PorA P1.4)
|
83.2 Percentage of participants
Interval 79.4 to 86.5
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
M13520 (NHBA)
|
76.6 Percentage of participants
Interval 72.5 to 80.4
|
—
|
PRIMARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=478 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp), NZ98/254 (PorA P1.4), and M13520 (NHBA) and >= 16 for Strain 96217 (NadA) (Composite Response Across All Strains)
|
63.2 Percentage of participants
Interval 58.5 to 67.7
|
—
|
PRIMARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=244 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=278 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 1
|
1.6 Microgram per milliliter(µg/mL)
Interval 1.4 to 1.9
|
1.5 Microgram per milliliter(µg/mL)
Interval 1.3 to 1.8
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 3
|
0.5 Microgram per milliliter(µg/mL)
Interval 0.4 to 0.6
|
0.5 Microgram per milliliter(µg/mL)
Interval 0.4 to 0.6
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 4
|
1.1 Microgram per milliliter(µg/mL)
Interval 0.9 to 1.3
|
1.1 Microgram per milliliter(µg/mL)
Interval 1.0 to 1.3
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 5
|
1.0 Microgram per milliliter(µg/mL)
Interval 0.8 to 1.2
|
1.0 Microgram per milliliter(µg/mL)
Interval 0.8 to 1.2
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 6
|
2.4 Microgram per milliliter(µg/mL)
Interval 2.0 to 2.8
|
2.5 Microgram per milliliter(µg/mL)
Interval 2.1 to 2.9
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 6B
|
1.5 Microgram per milliliter(µg/mL)
Interval 1.1 to 1.9
|
1.8 Microgram per milliliter(µg/mL)
Interval 1.4 to 2.3
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 7F
|
2.8 Microgram per milliliter(µg/mL)
Interval 2.4 to 3.3
|
2.9 Microgram per milliliter(µg/mL)
Interval 2.5 to 3.3
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 9V
|
1.3 Microgram per milliliter(µg/mL)
Interval 1.1 to 1.6
|
1.4 Microgram per milliliter(µg/mL)
Interval 1.2 to 1.6
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 14
|
5.9 Microgram per milliliter(µg/mL)
Interval 4.7 to 7.4
|
5.8 Microgram per milliliter(µg/mL)
Interval 4.8 to 7.2
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 18C
|
1.5 Microgram per milliliter(µg/mL)
Interval 1.3 to 1.8
|
1.5 Microgram per milliliter(µg/mL)
Interval 1.3 to 1.8
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 19A
|
1.7 Microgram per milliliter(µg/mL)
Interval 1.4 to 2.0
|
1.8 Microgram per milliliter(µg/mL)
Interval 1.6 to 2.2
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 19F
|
2.5 Microgram per milliliter(µg/mL)
Interval 2.1 to 2.9
|
2.5 Microgram per milliliter(µg/mL)
Interval 2.2 to 2.9
|
|
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Serotype 23F
|
0.9 Microgram per milliliter(µg/mL)
Interval 0.7 to 1.1
|
1.0 Microgram per milliliter(µg/mL)
Interval 0.8 to 1.2
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to PCV13 is evaluated by measuring IgG levels using ECL assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the 4th vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=225 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=240 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 1
|
1.8 µg/mL
Interval 1.5 to 2.1
|
1.8 µg/mL
Interval 1.6 to 2.1
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 3
|
0.5 µg/mL
Interval 0.4 to 0.6
|
0.5 µg/mL
Interval 0.5 to 0.6
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 4
|
1.5 µg/mL
Interval 1.2 to 1.8
|
1.7 µg/mL
Interval 1.4 to 2.0
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 5
|
1.8 µg/mL
Interval 1.5 to 2.1
|
1.8 µg/mL
Interval 1.6 to 2.1
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 6
|
5.2 µg/mL
Interval 4.4 to 6.1
|
6.0 µg/mL
Interval 5.2 to 7.0
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 6B
|
4.7 µg/mL
Interval 3.9 to 5.6
|
5.4 µg/mL
Interval 4.6 to 6.4
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 7F
|
3.7 µg/mL
Interval 3.2 to 4.4
|
4.6 µg/mL
Interval 4.0 to 5.3
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 9V
|
2.3 µg/mL
Interval 2.0 to 2.8
|
2.6 µg/mL
Interval 2.2 to 3.1
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 14
|
7.0 µg/mL
Interval 5.8 to 8.4
|
7.1 µg/mL
Interval 6.0 to 8.4
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 18C
|
2.0 µg/mL
Interval 1.7 to 2.4
|
2.2 µg/mL
Interval 1.9 to 2.6
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 19A
|
4.5 µg/mL
Interval 3.8 to 5.3
|
5.5 µg/mL
Interval 4.7 to 6.4
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 19F
|
4.8 µg/mL
Interval 4.1 to 5.7
|
5.0 µg/mL
Interval 4.3 to 5.9
|
|
Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Serotype 23F
|
1.9 µg/mL
Interval 1.5 to 2.3
|
1.9 µg/mL
Interval 1.6 to 2.3
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination) and Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to PCV13 is evaluated by measuring the percentage of participants with serum IgG concentrations ≥ 0.35 μg/mL for each of the 13 PCV13 antigens at 1 month after the third and fourth vaccinations.
Outcome measures
| Measure |
MenB+PCV Group
n=244 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=278 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 1, At Day 151
|
99.2 Percentage of participants
Interval 97.1 to 99.9
|
97.1 Percentage of participants
Interval 94.4 to 98.7
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 1, At Day 331
|
98.7 Percentage of participants
Interval 96.2 to 99.7
|
97.1 Percentage of participants
Interval 94.1 to 98.8
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 3, At Day 151
|
59.8 Percentage of participants
Interval 53.4 to 66.0
|
61.5 Percentage of participants
Interval 55.5 to 67.3
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 3, At Day 331
|
63.6 Percentage of participants
Interval 56.9 to 69.8
|
69.5 Percentage of participants
Interval 63.2 to 75.2
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 4, At Day 151
|
94.3 Percentage of participants
Interval 90.6 to 96.8
|
96.0 Percentage of participants
Interval 93.0 to 98.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 4, At Day 331
|
97.8 Percentage of participants
Interval 94.9 to 99.3
|
96.7 Percentage of participants
Interval 93.5 to 98.6
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 5, At Day 151
|
91.0 Percentage of participants
Interval 86.7 to 94.3
|
87.4 Percentage of participants
Interval 82.9 to 91.1
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 5, At Day 331
|
96.0 Percentage of participants
Interval 92.5 to 98.2
|
98.8 Percentage of participants
Interval 96.4 to 99.7
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 6, At Day 151
|
99.2 Percentage of participants
Interval 97.1 to 99.9
|
99.6 Percentage of participants
Interval 98.0 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 6, At Day 331
|
100 Percentage of participants
Interval 98.4 to 100.0
|
99.6 Percentage of participants
Interval 97.7 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 6B, At Day 151
|
89.8 Percentage of participants
Interval 85.2 to 93.3
|
92.4 Percentage of participants
Interval 88.7 to 95.3
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 6B, At Day 331
|
100 Percentage of participants
Interval 98.4 to 100.0
|
99.6 Percentage of participants
Interval 97.7 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 7F, At Day 151
|
99.6 Percentage of participants
Interval 97.7 to 100.0
|
100 Percentage of participants
Interval 98.7 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 7F, At Day 331
|
99.6 Percentage of participants
Interval 97.5 to 100.0
|
100 Percentage of participants
Interval 98.5 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 9V, At Day 151
|
95.1 Percentage of participants
Interval 91.6 to 97.4
|
93.2 Percentage of participants
Interval 89.5 to 95.8
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 9V, At Day 331
|
98.7 Percentage of participants
Interval 96.1 to 99.7
|
98.8 Percentage of participants
Interval 96.4 to 99.7
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 14, At Day 151
|
98.0 Percentage of participants
Interval 95.3 to 99.3
|
98.6 Percentage of participants
Interval 96.4 to 99.6
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 14, At Day 331
|
100 Percentage of participants
Interval 98.4 to 100.0
|
100 Percentage of participants
Interval 98.5 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 18C, At Day 151
|
97.5 Percentage of participants
Interval 94.7 to 99.1
|
96.8 Percentage of participants
Interval 93.9 to 98.5
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 18C, At Day 331
|
99.1 Percentage of participants
Interval 96.8 to 99.9
|
99.2 Percentage of participants
Interval 97.0 to 99.9
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 19A, At Day 151
|
96.7 Percentage of participants
Interval 93.6 to 98.6
|
98.6 Percentage of participants
Interval 96.4 to 99.6
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 19A, At Day 331
|
100 Percentage of participants
Interval 98.4 to 100.0
|
99.6 Percentage of participants
Interval 97.7 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 19F, At Day 151
|
99.6 Percentage of participants
Interval 97.7 to 100.0
|
100 Percentage of participants
Interval 98.7 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 19F, At Day 331
|
100 Percentage of participants
Interval 98.4 to 100.0
|
100 Percentage of participants
Interval 98.5 to 100.0
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 23F, At Day 151
|
87.3 Percentage of participants
Interval 82.5 to 91.2
|
87.0 Percentage of participants
Interval 82.5 to 90.7
|
|
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Serotype 23F, At Day 331
|
97.3 Percentage of participants
Interval 94.3 to 99.0
|
97.1 Percentage of participants
Interval 94.1 to 98.8
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to DTaP-HBV-IPV (Pediarix) vaccine is evaluated. IgG concentrations for pertussis antigens (PT, FHA, PRN) are measured at 1 month after the third vaccination and are expressed as international units per millilitre (IU/mL).
Outcome measures
| Measure |
MenB+PCV Group
n=470 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=266 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])
PT
|
50.3 IU/mL
Interval 45.1 to 56.0
|
59.6 IU/mL
Interval 53.2 to 66.8
|
|
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])
FHA
|
106.7 IU/mL
Interval 96.4 to 118.0
|
133.1 IU/mL
Interval 119.5 to 148.2
|
|
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])
Pertactin
|
41.7 IU/mL
Interval 36.1 to 48.1
|
65.7 IU/mL
Interval 56.4 to 76.4
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Hepatitis B (HepB) antigens are measured at 1 month after the third vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=105 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=138 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Antibodies Concentrations Against Hepatitis B Surface Antigen (AntiHBsAg) >= 10 mIU/mL
|
100 Percentage of participants
Interval 96.5 to 100.0
|
99.3 Percentage of participants
Interval 96.0 to 100.0
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to DTaP-HBV-IPV vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for diphtheria (D) and tetanus (T) were measured at 1 month after the third vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=224 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=143 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL
Tetanus Toxoid
|
100 Percentage of participants
Interval 98.4 to 100.0
|
100 Percentage of participants
Interval 97.5 to 100.0
|
|
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL
Diphtheria Toxoid
|
99.5 Percentage of participants
Interval 97.5 to 100.0
|
100 Percentage of participants
Interval 97.3 to 100.0
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to Hib vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for Haemophilus influenzae type b (Hib) are measured at 1 month after the third vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=347 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=264 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Anti-polyribosyl-ribitol Phosphate (PRP) Concentration >= 0.15 µg/mL and >= 1 µg/mL
>= 0.15 µg/mL
|
98.3 Percentage of participants
Interval 96.3 to 99.4
|
97.7 Percentage of participants
Interval 95.1 to 99.2
|
|
Percentage of Participants With Anti-polyribosyl-ribitol Phosphate (PRP) Concentration >= 0.15 µg/mL and >= 1 µg/mL
>= 1 µg/mL
|
87.0 Percentage of participants
Interval 83.0 to 90.4
|
84.1 Percentage of participants
Interval 79.1 to 88.3
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for measles antigens are measured using adjusted GMCs at 1 month after fourth vaccination and are expressed as milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
MenB+PCV Group
n=435 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=235 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs for Anti-measles Antibodies
|
877.3 mIU/mL
Interval 743.7 to 1035.0
|
873.5 mIU/mL
Interval 732.2 to 1042.0
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for mumps antigens are measured using adjusted GMCs at 1 month after fourth vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=435 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=235 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs for Anti-mumps Antibodies
|
744.5 Arbitrary Units per milliliter (AU/mL)
Interval 628.5 to 882.0
|
856.8 Arbitrary Units per milliliter (AU/mL)
Interval 715.0 to 1026.7
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to MMR vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for rubella antigens are measured using adjusted GMCs at 1 month after fourth vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=432 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=235 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs for Anti-rubella Antibodies
|
57.7 IU/mL
Interval 50.0 to 66.6
|
54.0 IU/mL
Interval 46.3 to 63.0
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
The immune response to varicella (VV) vaccine administered with rMenB+OMV NZ and PCV13 is evaluated. IgG concentrations for varicella antigens are measured using GMCs at 1 month after fourth vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=437 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=231 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Adjusted GMCs for Anti-Varicella (VV) Antibodies
|
1283.8 mIU/mL
Interval 1137.4 to 1449.2
|
1208.9 mIU/mL
Interval 1060.5 to 1378.2
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=553 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 5
|
92.2 Percentage of participants
Interval 89.6 to 94.3
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 8
|
82.9 Percentage of participants
Interval 79.4 to 86.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 16
|
50.5 Percentage of participants
Interval 46.2 to 54.8
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), >= 5
|
99.6 Percentage of participants
Interval 98.6 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), >= 8
|
99.6 Percentage of participants
Interval 98.6 to 100.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), >= 16
|
99.4 Percentage of participants
Interval 98.3 to 99.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 5
|
77.7 Percentage of participants
Interval 74.0 to 81.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 8
|
61.8 Percentage of participants
Interval 57.6 to 65.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 16
|
31.1 Percentage of participants
Interval 27.2 to 35.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), >= 5
|
60.4 Percentage of participants
Interval 56.2 to 64.5
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), >= 8
|
32.4 Percentage of participants
Interval 28.5 to 36.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), >= 16
|
9.4 Percentage of participants
Interval 7.1 to 12.1
|
—
|
SECONDARY outcome
Timeframe: At Day 301 (6 months after third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=540 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 5
|
14.5 Percentage of participants
Interval 11.6 to 17.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 8
|
4.8 Percentage of participants
Interval 3.2 to 7.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA) >= 5
|
97.8 Percentage of participants
Interval 96.1 to 98.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), >= 8
|
96.4 Percentage of participants
Interval 94.4 to 97.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 5
|
20.2 Percentage of participants
Interval 16.8 to 23.8
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 8
|
12.2 Percentage of participants
Interval 9.6 to 15.3
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), >= 5
|
10.2 Percentage of participants
Interval 7.8 to 13.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA) >= 8
|
5.9 Percentage of participants
Interval 4.1 to 8.3
|
—
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=505 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), >= 5
|
94.5 Percentage of participants
Interval 92.1 to 96.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), >= 5
|
99.6 Percentage of participants
Interval 98.5 to 99.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), >= 5
|
89.6 Percentage of participants
Interval 86.6 to 92.1
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), >= 5
|
91.5 Percentage of participants
Interval 88.7 to 93.8
|
—
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination), Day 301 (6 months after the third vaccination), and Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=553 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 151
|
15.1 Titer
Interval 13.7 to 16.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 301
|
3.0 Titer
Interval 2.8 to 3.2
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 331
|
24.3 Titer
Interval 21.3 to 27.8
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 151
|
488.2 Titer
Interval 437.3 to 545.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 301
|
89.1 Titer
Interval 77.3 to 102.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 331
|
1349.0 Titer
Interval 1195.3 to 1522.5
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 151
|
10.1 Titer
Interval 8.9 to 11.4
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 301
|
3.8 Titer
Interval 3.5 to 4.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 331
|
20.3 Titer
Interval 17.3 to 23.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 151
|
5.5 Titer
Interval 5.0 to 6.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 301
|
3.5 Titer
Interval 3.3 to 3.7
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 331
|
12.7 Titer
Interval 11.2 to 14.4
|
—
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination) compared to Day 301 (pre-fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=465 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp)
|
8.7 Ratio
Interval 7.6 to 10.0
|
—
|
|
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA)
|
17.4 Ratio
Interval 15.1 to 20.1
|
—
|
|
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4)
|
5.5 Ratio
Interval 4.7 to 6.5
|
—
|
|
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA)
|
3.9 Ratio
Interval 3.4 to 4.4
|
—
|
SECONDARY outcome
Timeframe: At Day 301 (6 months after the third vaccination) and Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
This immune response to the rMenB+OMV NZ vaccine only is evaluated, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=540 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 301
|
14.5 Percentage of participants
Interval 11.6 to 17.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 331
|
94.5 Percentage of participants
Interval 92.1 to 96.4
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 301
|
94.1 Percentage of participants
Interval 91.6 to 96.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 331
|
99.6 Percentage of participants
Interval 98.5 to 99.9
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 301
|
8.5 Percentage of participants
Interval 6.3 to 11.2
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 331
|
86.1 Percentage of participants
Interval 82.8 to 89.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 301
|
17.5 Percentage of participants
Interval 14.4 to 21.0
|
—
|
|
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 331
|
87.6 Percentage of participants
Interval 84.4 to 90.3
|
—
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination) relative to Day 301 (pre-fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
A 4-fold rise in hSBA titers is defined as - if pre-vaccination titer \<Limit of Detection (LOD), then a post-vaccination titer \>= 4 times the LOD or \>= LLOQ, whichever is greater; - if pre-vaccination titer is \>= LOD but \<LLOQ, then a post-vaccination titer \>= 4 times the LLOQ; - if pre-vaccination titer is \>= LLOQ, then a post-vaccination titer \>= 4 times the pre-vaccination titer, where pre-vaccination titer=pre-4th dose titers (Day 301). This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Outcome measures
| Measure |
MenB+PCV Group
n=465 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M14459 (fHbp), Day 331
|
72.0 Percentage of participants
Interval 67.5 to 76.1
|
—
|
|
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
96217 (NadA), Day 331
|
94.8 Percentage of participants
Interval 92.2 to 96.7
|
—
|
|
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
M13520 (NHBA), Day 331
|
36.1 Percentage of participants
Interval 31.8 to 40.7
|
—
|
|
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
NZ98/254 (PorA P1.4), Day 331
|
54.2 Percentage of participants
Interval 49.5 to 58.9
|
—
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=105 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=138 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Anti-HBs Antibody Concentrations >= 100 mIU/mL
|
98.1 Percentage of participants
Interval 93.3 to 99.8
|
96.4 Percentage of participants
Interval 91.7 to 98.8
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=105 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=138 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
GMCs for Anti-HBsAg Antibodies
|
2201.0 mIU/mL
Interval 1554.7 to 3116.0
|
2404.8 mIU/mL
Interval 1803.1 to 3207.3
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=224 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=143 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 1 IU/mL
Tetanus Toxoid
|
67.0 Percentage of participants
Interval 60.4 to 73.1
|
69.2 Percentage of participants
Interval 61.0 to 76.7
|
|
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 1 IU/mL
Diphtheria Toxoid
|
40.0 Percentage of participants
Interval 33.5 to 46.8
|
55.1 Percentage of participants
Interval 46.4 to 63.7
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=224 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=143 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
GMCs for Anti-diphtheria and Anti-tetanus Antibodies
Tetanus Toxoid
|
1.5 IU/mL
Interval 1.3 to 1.8
|
1.6 IU/mL
Interval 1.3 to 1.9
|
|
GMCs for Anti-diphtheria and Anti-tetanus Antibodies
Diphtheria Toxoid
|
0.9 IU/mL
Interval 0.8 to 1.1
|
1.2 IU/mL
Interval 1.0 to 1.5
|
SECONDARY outcome
Timeframe: At Day 151 (1 month after the third vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Outcome measures
| Measure |
MenB+PCV Group
n=106 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=120 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8
Polio 2
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
100 Percentage of participants
Interval 96.9 to 100.0
|
|
Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8
Polio 1
|
100 Percentage of participants
Interval 96.4 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8
Polio 3
|
100 Percentage of participants
Interval 96.3 to 100.0
|
99.1 Percentage of participants
Interval 95.1 to 100.0
|
SECONDARY outcome
Timeframe: At Day 331 (1 month after the fourth vaccination)Population: Analysis was performed on the PPS for immunogenicity. Only participants with data available at the specified timepoints were included in this analysis.
Seroresponse is defined as post-vaccination anti-VZV virus, anti-measles virus, anti-mumps virus and anti-rubella virus antibody concentration \>= a protective threshold among participants who were seronegative (antibody concentration \< assay cut-off) before vaccination.
Outcome measures
| Measure |
MenB+PCV Group
n=364 Participants
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=201 Participants
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies
Mumps
|
81.6 Percentage of participants
Interval 77.2 to 85.5
|
85.9 Percentage of participants
Interval 80.2 to 90.4
|
|
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies
Measles
|
94.8 Percentage of participants
Interval 91.9 to 96.9
|
97.9 Percentage of participants
Interval 94.7 to 99.4
|
|
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies
Rubella
|
86.4 Percentage of participants
Interval 82.3 to 89.8
|
83.9 Percentage of participants
Interval 78.1 to 88.7
|
|
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies
VZV gE
|
97.3 Percentage of participants
Interval 95.0 to 98.7
|
97.5 Percentage of participants
Interval 94.3 to 99.2
|
Adverse Events
MenB+PCV Group
Serious events: 35 serious events
Other events: 771 other events
Deaths: 0 deaths
Placebo+PCV Group
Serious events: 19 serious events
Other events: 389 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenB+PCV Group
n=781 participants at risk
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=403 participants at risk
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Bronchogenic cyst
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Influenza like illness
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
PFAPA syndrome
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Pyrexia
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Immune system disorders
Anaphylactic reaction
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Immune system disorders
Serum sickness
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Bronchiolitis
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
COVID-19
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Cellulitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Clostridium difficile colitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Coxsackie viral infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Gastroenteritis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Gastroenteritis viral
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Influenza
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Picornavirus infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pneumonia
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pneumonia bacterial
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Rhinovirus infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Tonsillitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Urinary tract infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Viral infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Febrile convulsion
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Seizure
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
Other adverse events
| Measure |
MenB+PCV Group
n=781 participants at risk
Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.
|
Placebo+PCV Group
n=403 participants at risk
Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.
|
|---|---|---|
|
Investigations
Blood lead increased
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.0%
16/781 • Number of events 17 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
3.0%
12/403 • Number of events 12 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Wound infection
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Body temperature decreased
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Urinary tract infection
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Viral infection
|
1.7%
13/781 • Number of events 14 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.7%
7/403 • Number of events 7 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Viral pharyngitis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Viral rash
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.13%
1/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Contusion
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Fall
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Foreign body ingestion
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Head injury
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Scar
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Scrotal injury
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Superficial injury of eye
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Body temperature increased
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Breath sounds abnormal
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Cardiac murmur
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Occult blood positive
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Platelet count increased
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
SARS-CoV-2 test positive
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Serum ferritin decreased
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.99%
4/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
Weight decreased
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Investigations
White blood cell count decreased
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Breast milk substitute intolerance
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Hypophagia
|
69.5%
543/781 • Number of events 544 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
53.6%
216/403 • Number of events 217 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Milk soy protein intolerance
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Acquired plagiocephaly
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Jaw clicking
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Joint noise
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
2/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Drooling
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Fine motor delay
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Infant irritability
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Lethargy
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Movement disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Somnolence
|
87.2%
681/781 • Number of events 681 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
79.2%
319/403 • Number of events 322 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Nervous system disorders
Speech disorder developmental
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Breath holding
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Dependent personality disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Emotional distress
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Insomnia
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.2%
5/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Irritability
|
91.3%
713/781 • Number of events 738 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
81.9%
330/403 • Number of events 345 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Selective eating disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Renal and urinary disorders
Renal hypertrophy
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Renal and urinary disorders
Single functional kidney
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Genital labial adhesions
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Genital rash
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Penile adhesion
|
0.38%
3/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Penile cyst
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Penile dermatitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.99%
4/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
20/781 • Number of events 21 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
5.0%
20/403 • Number of events 23 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Brachycephaly
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Craniofacial deformity
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Dacryostenosis congenital
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Kidney duplex
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Macrocephaly
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Plagiocephaly
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Strabismus congenital
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Congenital, familial and genetic disorders
Tethered oral tissue
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Ear pain
|
1.2%
9/781 • Number of events 9 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.2%
5/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Astigmatism
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Dacryostenosis acquired
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eye discharge
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eye movement disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eye swelling
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eyelid oedema
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Eyelid rash
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Ocular hyperaemia
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Pseudostrabismus
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Scleral discolouration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Eye disorders
Swelling of eyelid
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Anal fissure
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Constipation
|
4.0%
31/781 • Number of events 32 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
3.0%
12/403 • Number of events 13 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Diarrhoea
|
42.8%
334/781 • Number of events 350 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
44.2%
178/403 • Number of events 193 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Faeces hard
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Flatulence
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Food protein-induced enterocolitis syndrome
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.8%
14/781 • Number of events 14 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
2.2%
9/403 • Number of events 9 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Gastrooesophageal reflux in neonate
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Gingival cyst
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Gingival disorder
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Haematochezia
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Infantile colic
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Infantile spitting up
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Mucous stools
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Oral mucosal eruption
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Protein-losing gastroenteropathy
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Regurgitation
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Stomatitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Teething
|
9.6%
75/781 • Number of events 84 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
11.4%
46/403 • Number of events 55 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Toothache
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
317/781 • Number of events 328 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
39.5%
159/403 • Number of events 174 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Administration site erythema
|
58.9%
460/781 • Number of events 460 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
42.2%
170/403 • Number of events 170 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Administration site induration
|
61.5%
480/781 • Number of events 480 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
44.7%
180/403 • Number of events 180 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Administration site pain
|
74.5%
582/781 • Number of events 582 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
49.9%
201/403 • Number of events 201 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Administration site swelling
|
41.2%
322/781 • Number of events 322 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
30.3%
122/403 • Number of events 122 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Adverse drug reaction
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Adverse food reaction
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Chills
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Crying
|
55.3%
432/781 • Number of events 433 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
40.4%
163/403 • Number of events 163 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Fatigue
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Hypothermia
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Induration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Inflammation
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Influenza like illness
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site bruising
|
0.77%
6/781 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.5%
6/403 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site discolouration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site dryness
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site erythema
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site induration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site laceration
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site nodule
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site rash
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site reaction
|
0.13%
1/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site swelling
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injection site urticaria
|
0.13%
1/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Injury associated with device
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Irritability postvaccinal
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Pain
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Peripheral swelling
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Pyrexia
|
66.7%
521/781 • Number of events 543 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
42.7%
172/403 • Number of events 184 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Swelling
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Swelling face
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Tenderness
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Vaccination site bruising
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
General disorders
Vaccination site irritation
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Immune system disorders
Drug hypersensitivity
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Immune system disorders
Food allergy
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Immune system disorders
Seasonal allergy
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Abscess limb
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Acute sinusitis
|
0.26%
2/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Body tinea
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Bronchiolitis
|
3.8%
30/781 • Number of events 31 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
3.2%
13/403 • Number of events 16 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Bronchitis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Bullous impetigo
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
COVID-19
|
0.77%
6/781 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.2%
5/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Candida infection
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Candida nappy rash
|
1.3%
10/781 • Number of events 11 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Cellulitis
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Conjunctivitis
|
2.2%
17/781 • Number of events 20 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
3.7%
15/403 • Number of events 17 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Coxsackie viral infection
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Croup infectious
|
3.1%
24/781 • Number of events 25 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Cystitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Dacryocystitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Ear infection
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Erythema infectiosum
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Exanthema subitum
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Eye infection
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Folliculitis
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Fungal skin infection
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Gastroenteritis
|
1.0%
8/781 • Number of events 8 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.2%
5/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Gastroenteritis viral
|
1.2%
9/781 • Number of events 9 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.90%
7/781 • Number of events 7 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Impetigo
|
0.38%
3/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Influenza
|
1.7%
13/781 • Number of events 13 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Injection site cellulitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Laryngotracheitis obstructive
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Nail infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
40/781 • Number of events 46 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
4.5%
18/403 • Number of events 20 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Onychomycosis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Oral candidiasis
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.99%
4/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Oral viral infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Otitis externa
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Otitis media
|
6.0%
47/781 • Number of events 55 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
7.2%
29/403 • Number of events 37 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Otitis media acute
|
4.2%
33/781 • Number of events 42 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
5.7%
23/403 • Number of events 28 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Otitis media chronic
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Paronychia
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Parvovirus infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Periorbital cellulitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pertussis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pharyngitis
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pneumonia
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Pustule
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.2%
9/781 • Number of events 9 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory tract infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Respiratory tract infection viral
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Rhinitis
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Roseola
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Rotavirus infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Sinusitis
|
0.77%
6/781 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.5%
6/403 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Skin candida
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Skin infection
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Suspected COVID-19
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Tinea cruris
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
125/781 • Number of events 149 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
15.4%
62/403 • Number of events 79 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Brief resolved unexplained event
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
51/781 • Number of events 58 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
5.0%
20/403 • Number of events 25 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
39/781 • Number of events 44 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
4.2%
17/403 • Number of events 19 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
4.0%
31/781 • Number of events 39 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
4.2%
17/403 • Number of events 20 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.38%
3/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.2%
25/781 • Number of events 27 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
3.0%
12/403 • Number of events 14 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.77%
6/781 • Number of events 6 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
1.2%
5/403 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Acne infantile
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
9/781 • Number of events 9 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.50%
2/403 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
1.0%
8/781 • Number of events 8 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
4.9%
38/781 • Number of events 41 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
5.5%
22/403 • Number of events 25 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.51%
4/781 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.99%
4/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.0%
16/781 • Number of events 16 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
2.5%
10/403 • Number of events 10 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.90%
7/781 • Number of events 7 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Post inflammatory pigmentation change
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.7%
216/781 • Number of events 224 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
26.3%
106/403 • Number of events 117 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/781 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.99%
4/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.26%
2/781 • Number of events 2 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.64%
5/781 • Number of events 5 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.74%
3/403 • Number of events 4 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Social circumstances
Child abuse
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Vascular disorders
Cyanosis
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Vascular disorders
Flushing
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Vascular disorders
Lymphoedema
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.00%
0/403 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Vascular disorders
Pallor
|
0.38%
3/781 • Number of events 3 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
|
Vascular disorders
Scalp haematoma
|
0.13%
1/781 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
0.25%
1/403 • Number of events 1 • Solicited AEs: Day 1 to Day 7 post each vaccination, Solicited systemic AEs of salivary gland swelling, fever and rash: Day 1 to Day 30 post fourth vaccination; Unsolicited AEs: Day 1 to Day 30 post each vaccination. All-cause mortality, SAEs, AEs leading to withdrawal, AESIs and MAAEs: For participants not reaching Day 481 by Protocol Amendment 7: first vaccination (Day 1) to Day 481, for participants past Day 481 by the amendment: first vaccination (Day 1) to Day 661
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER