Trial Outcomes & Findings for A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above (NCT NCT05559476)
NCT ID: NCT05559476
Last Updated: 2024-09-24
Results Overview
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1029 participants
Primary outcome timeframe
At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)
Results posted on
2024-09-24
Participant Flow
1029 participants received at least one dose of the study intervention and were included in the exposed set.
This study assessed the immunogenicity, safety and reactogenicity of the RSVPre3 OA vaccine when co-administered with Flu High-Dose vaccine (FLU-HD \[FLU\]), in adults aged 65 years old or above.
Participant milestones
| Measure |
Co-Ad Group
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Overall Study
STARTED
|
516
|
513
|
|
Overall Study
COMPLETED
|
493
|
485
|
|
Overall Study
NOT COMPLETED
|
23
|
28
|
Reasons for withdrawal
| Measure |
Co-Ad Group
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
13
|
12
|
|
Overall Study
Consent withdrawal, not due to a (S)AE
|
8
|
14
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above
Baseline characteristics by cohort
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
Total
n=1029 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.3 YEARS
STANDARD_DEVIATION 5.3 • n=5 Participants
|
71.1 YEARS
STANDARD_DEVIATION 5.1 • n=7 Participants
|
71.2 YEARS
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
267 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
510 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
249 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
519 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alasaka Native
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
355 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
707 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)Population: Analysis was performed on Per Protocol Set (PPS) for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Outcome measures
| Measure |
Co-Ad Group
n=457 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=414 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
|
5876.3 Titers
Interval 5299.5 to 6515.9
|
6935.3 Titers
Interval 6200.0 to 7757.9
|
PRIMARY outcome
Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups)Population: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.
Outcome measures
| Measure |
Co-Ad Group
n=456 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=440 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Flu A/Darwin/6/2021 H3N2
|
72.7 Titers
Interval 64.1 to 82.5
|
72.3 Titers
Interval 63.7 to 82.1
|
|
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Flu A/Victoria/2570/2019 H1N1
|
189.9 Titers
Interval 167.6 to 215.1
|
177.3 Titers
Interval 156.4 to 200.9
|
|
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Flu B/Austria/1359417/2021 Victoria
|
859.8 Titers
Interval 805.8 to 917.5
|
820.9 Titers
Interval 768.8 to 876.6
|
|
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
Flu B/Phuket/3073/2013 Yamagata
|
758.7 Titers
Interval 699.1 to 823.4
|
703.4 Titers
Interval 647.7 to 763.9
|
PRIMARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)Population: Analysis was performed on PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).
Outcome measures
| Measure |
Co-Ad Group
n=457 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=355 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
RSV-B Neutralizing Titers Expressed as Group GMTs
|
8251.5 Titers
Interval 7460.6 to 9126.3
|
8359.0 Titers
Interval 7492.8 to 9325.3
|
SECONDARY outcome
Timeframe: At 1 month after the FLU vaccine dose (Day 31 for both groups)Population: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
SCR for HI titers was defined as the percentage of participants who have either a HI predose titer less than (\<) 1:10 and a post-dose titer greater than or equal to (\>=) 1:40, or a pre-dose titer \>= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Outcome measures
| Measure |
Co-Ad Group
n=456 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=440 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2
|
59.2 Percentage of participants
Interval 54.5 to 63.8
|
57.5 Percentage of participants
Interval 52.7 to 62.2
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1
|
50.9 Percentage of participants
Interval 46.2 to 55.6
|
46.8 Percentage of participants
Interval 42.0 to 51.6
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria
|
39.7 Percentage of participants
Interval 35.2 to 44.3
|
31.1 Percentage of participants
Interval 26.8 to 35.7
|
|
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata
|
43.6 Percentage of participants
Interval 39.0 to 48.3
|
37.7 Percentage of participants
Interval 33.2 to 42.4
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)Population: Analysis was performed on PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Co-Ad Group
n=457 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=356 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
RSV-A Neutralizing Titers Expressed as Mean Geometric Increase (MGI)
|
5.59 Ratio
Interval 5.02 to 6.23
|
6.75 Ratio
Interval 5.93 to 7.68
|
SECONDARY outcome
Timeframe: At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)Population: Analysis was performed on PPS for RSV analysis which included eligible participants who: received RSVPreF3 OA vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post- RSVPreF3 OA vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Co-Ad Group
n=457 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=355 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
RSV-B Neutralizing Titers Expressed as MGI
|
5.19 Ratio
Interval 4.69 to 5.75
|
5.29 Ratio
Interval 4.65 to 6.03
|
SECONDARY outcome
Timeframe: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)Population: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains. HI antibodies were expressed as GMTs, in titers.
Outcome measures
| Measure |
Co-Ad Group
n=507 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=503 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu A/Darwin/6/2021 H3N2, Day 1
|
11.5 Titers
Interval 10.5 to 12.7
|
12.6 Titers
Interval 11.4 to 14.0
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu A/Darwin/6/2021 H3N2, Day 31
|
71.8 Titers
Interval 63.6 to 81.0
|
75.1 Titers
Interval 66.7 to 84.4
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu A/Victoria/2570/2019 H1N1, Day 1
|
35.3 Titers
Interval 31.2 to 40.1
|
41.9 Titers
Interval 36.9 to 47.6
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu A/Victoria/2570/2019 H1N1, Day 31
|
200.0 Titers
Interval 178.7 to 223.8
|
194.7 Titers
Interval 173.9 to 217.9
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu B/Austria/1359417/2021 Victoria, Day 1
|
292.6 Titers
Interval 270.6 to 316.4
|
308.5 Titers
Interval 285.8 to 333.1
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu B/Austria/1359417/2021 Victoria, Day 31
|
848.0 Titers
Interval 799.7 to 899.2
|
818.3 Titers
Interval 769.2 to 870.5
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu B/Phuket/3073/2013 Yamagata, Day 1
|
239.2 Titers
Interval 220.6 to 259.3
|
245.5 Titers
Interval 226.1 to 266.5
|
|
HI Titers for Each of the 4 FLU Vaccine Strains Expressed as GMT
Flu B/Phuket/3073/2013 Yamagata, Day 31
|
751.1 Titers
Interval 698.9 to 807.2
|
699.6 Titers
Interval 646.9 to 756.6
|
SECONDARY outcome
Timeframe: At Day 1 and 1 month after FLU vaccine dose administration (Day 31 for both groups)Population: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
SPR for HI titers was defined as the percentage of participants with a serum HI titer \>= 1:40. The assessed Flu strains were: The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata.
Outcome measures
| Measure |
Co-Ad Group
n=507 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=503 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2, Day 1
|
17.9 Percentage of participants
Interval 14.7 to 21.6
|
21.9 Percentage of participants
Interval 18.3 to 25.7
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Darwin/6/2021 H3N2, Day 31
|
75.3 Percentage of participants
Interval 71.1 to 79.2
|
76.6 Percentage of participants
Interval 72.3 to 80.5
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 1
|
53.4 Percentage of participants
Interval 48.9 to 57.8
|
61.0 Percentage of participants
Interval 56.6 to 65.3
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu A/Victoria/2570/2019 H1N1, Day 31
|
92.3 Percentage of participants
Interval 89.5 to 94.6
|
94.5 Percentage of participants
Interval 92.0 to 96.5
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 1
|
98.8 Percentage of participants
Interval 97.4 to 99.6
|
99.6 Percentage of participants
Interval 98.6 to 100.0
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Austria/1359417/2021 Victoria, Day 31
|
100 Percentage of participants
Interval 99.2 to 100.0
|
100 Percentage of participants
Interval 99.2 to 100.0
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 1
|
96.8 Percentage of participants
Interval 94.9 to 98.2
|
98.2 Percentage of participants
Interval 96.6 to 99.2
|
|
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
Flu B/Phuket/3073/2013 Yamagata, Day 31
|
100 Percentage of participants
Interval 99.2 to 100.0
|
100 Percentage of participants
Interval 99.2 to 100.0
|
SECONDARY outcome
Timeframe: At 1 month after the FLU vaccine dose administration (Day 31 for both groups)Population: Analysis was performed on PPS for FLU analysis which included eligible participants who: received FLU vaccine dose in Control group and all study doses in Co-Ad group, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, had immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer.
Outcome measures
| Measure |
Co-Ad Group
n=456 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=440 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
Flu A/Darwin/6/2021 H3N2
|
6.20 Ratio
Interval 5.49 to 7.0
|
5.87 Ratio
Interval 5.2 to 6.62
|
|
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
Flu A/Victoria/2570/2019 H1N1
|
5.57 Ratio
Interval 4.81 to 6.46
|
4.53 Ratio
Interval 3.94 to 5.21
|
|
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
Flu B/Austria/1359417/2021 Victoria
|
2.92 Ratio
Interval 2.69 to 3.18
|
2.71 Ratio
Interval 2.51 to 2.93
|
|
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
Flu B/Phuket/3073/2013 Yamagata
|
3.13 Ratio
Interval 2.85 to 3.44
|
2.87 Ratio
Interval 2.62 to 3.14
|
SECONDARY outcome
Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)Population: Analysis was performed on Modified Safety Set, which included participants who received a study intervention, with the electronic diary completed post-each vaccination by the participant or authorized caregiver, and for whom solicited administration event data was available for the specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1.
The solicited administration site events after vaccination included erythema, pain and swelling.
Outcome measures
| Measure |
Co-Ad Group
n=423 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=414 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Erythema, Flu administration at Day 1
|
4.0 Percentage of participants
Interval 2.4 to 6.4
|
4.6 Percentage of participants
Interval 2.8 to 7.1
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Erythema, RSV administration at Day 1
|
4.3 Percentage of participants
Interval 2.5 to 6.6
|
—
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Erythema, RSV administration at Day 31
|
—
|
4.3 Percentage of participants
Interval 2.5 to 6.7
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Pain, Flu administration at Day 1
|
47.0 Percentage of participants
Interval 42.2 to 51.9
|
43.5 Percentage of participants
Interval 37.7 to 47.4
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Pain, RSV administration at Day 1
|
55.6 Percentage of participants
Interval 50.7 to 60.4
|
—
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Pain, RSV administration at Day 31
|
—
|
45.8 Percentage of participants
Interval 40.8 to 50.8
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Swelling, Flu administration at Day 1
|
4.5 Percentage of participants
Interval 2.7 to 6.9
|
5.6 Percentage of participants
Interval 3.6 to 8.2
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Swelling, RSV administration at Day 1
|
4.0 Percentage of participants
Interval 2.4 to 6.4
|
—
|
|
Percentage of Participants With Solicited Administration Site Events After Each Vaccine Dose Administration
Swelling, RSV administration at Day 31
|
—
|
4.3 Percentage of participants
Interval 2.5 to 6.7
|
SECONDARY outcome
Timeframe: Within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on Day 1 and 31)Population: Analysis was performed on Modified Safety Set, which included participants who received a study intervention, with the electronic diary completed post-each vaccination by the participant or authorized caregiver, and for whom solicited administration event data was available for the specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1.
The solicited systemic events after vaccination include arthralgia, fatigue, fever, headache and myalgia.
Outcome measures
| Measure |
Co-Ad Group
n=423 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=493 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Arthralgia, Dosing at Day 1
|
16.1 Percentage of participants
Interval 12.7 to 19.9
|
13.8 Percentage of participants
Interval 10.6 to 15.5
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Arthralgia, Dosing at Day 31
|
—
|
13.0 Percentage of participants
Interval 9.9 to 16.7
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Fatigue, Dosing at Day 1
|
30.5 Percentage of participants
Interval 26.1 to 35.1
|
22.0 Percentage of participants
Interval 18.1 to 26.3
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Fatigue, Dosing at Day 31
|
—
|
23.5 Percentage of participants
Interval 19.4 to 28.0
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Fever, Dosing at Day 1
|
2.1 Percentage of participants
Interval 1.0 to 4.0
|
0.7 Percentage of participants
Interval 0.1 to 2.1
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Fever, Dosing at Day 31
|
—
|
2.0 Percentage of participants
Interval 0.9 to 3.9
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Headache, Dosing at Day 1
|
24.3 Percentage of participants
Interval 20.3 to 28.7
|
17.1 Percentage of participants
Interval 13.6 to 21.1
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Headache, Dosing at Day 31
|
—
|
19.0 Percentage of participants
Interval 15.3 to 23.2
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Myalgia, Dosing at Day 1
|
40.2 Percentage of participants
Interval 35.5 to 45.0
|
34.1 Percentage of participants
Interval 29.5 to 38.8
|
|
Percentage of Participants Reporting Each Solicited Systemic Event After Each Vaccine Dose Administration
Myalgia, Dosing at Day 31
|
—
|
31.3 Percentage of participants
Interval 26.7 to 36.0
|
SECONDARY outcome
Timeframe: Within 30 days after vaccine administration (the day of vaccination and 29 subsequent days after vaccination)Population: Analysis was performed on Exposed set which included participants who received a study intervention.
An unsolicited AEs is an AE that is not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs).
Outcome measures
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
|
12.2 Percentage of participants
Interval 9.5 to 15.3
|
13.5 Percentage of participants
Interval 10.6 to 16.7
|
SECONDARY outcome
Timeframe: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)Population: Analysis was performed on Exposed set which included participants who received a study intervention.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Outcome measures
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs)
|
2.3 Percentage of participants
Interval 1.2 to 4.0
|
2.9 Percentage of participants
Interval 1.6 to 4.8
|
SECONDARY outcome
Timeframe: From Day 1 up to study end (6 months after last vaccination - Month 6 for Co-Ad Group and Month 7 for Control group)Population: Analysis was performed on Exposed set which included participants who received a study intervention.
pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e. pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD.
Outcome measures
| Measure |
Co-Ad Group
n=516 Participants
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 Participants
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Percentage of Participants Reporting Potential Immune-mediated Disease (pIMDs)
|
0 Percentage of participants
Interval 0.0 to 0.7
|
0.4 Percentage of participants
Interval 0.0 to 1.4
|
Adverse Events
Co-Ad Group
Serious events: 12 serious events
Other events: 339 other events
Deaths: 1 deaths
Control Group
Serious events: 15 serious events
Other events: 319 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Co-Ad Group
n=516 participants at risk
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 participants at risk
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Influenza
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Hemiparesis
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Syncope
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Vertigo
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
Other adverse events
| Measure |
Co-Ad Group
n=516 participants at risk
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
|
Control Group
n=513 participants at risk
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
|
|---|---|---|
|
General disorders
Injection site pain
|
52.9%
273/516 • Number of events 274 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
50.1%
257/513 • Number of events 371 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Fatigue
|
25.2%
130/516 • Number of events 132 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
27.3%
140/513 • Number of events 185 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site swelling
|
5.2%
27/516 • Number of events 27 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
6.6%
34/513 • Number of events 40 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Pyrexia
|
2.1%
11/516 • Number of events 11 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
2.5%
13/513 • Number of events 13 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Chills
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.78%
4/513 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site pruritus
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Pain
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Administration site erythema
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Administration site pain
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Administration site pruritus
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Asthenia
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Influenza like illness
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site paraesthesia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.1%
73/516 • Number of events 73 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
17.7%
91/513 • Number of events 109 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.58%
3/513 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Bone swelling
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Headache
|
21.9%
113/516 • Number of events 115 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
25.0%
128/513 • Number of events 157 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Balance disorder
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Dizziness
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Hypoaesthesia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Parosmia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Radiculitis brachial
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Sciatica
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Nervous system disorders
Syncope
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
COVID-19
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.9%
10/513 • Number of events 10 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.78%
4/516 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.2%
6/513 • Number of events 6 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Bronchitis
|
0.78%
4/516 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Nasopharyngitis
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.58%
3/513 • Number of events 3 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Sinusitis
|
0.78%
4/516 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Influenza
|
0.58%
3/516 • Number of events 3 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Urinary tract infection
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Tooth abscess
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Infections and infestations
Tooth infection
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
1.4%
7/513 • Number of events 7 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.78%
4/513 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.78%
4/513 • Number of events 4 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
7/516 • Number of events 8 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.78%
4/513 • Number of events 5 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Nausea
|
0.58%
3/516 • Number of events 3 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Vomiting
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Anal fissure
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Dry mouth
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Ear pain
|
0.58%
3/516 • Number of events 3 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.39%
2/513 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Cardiomegaly
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Insomnia
|
0.39%
2/516 • Number of events 2 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Hypertension
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Eye pruritus
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/516 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.19%
1/513 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Immune system disorders
Multiple allergies
|
0.19%
1/516 • Number of events 1 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
0.00%
0/513 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
General disorders
Injection site erythema
|
5.2%
27/516 • Number of events 27 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
6.6%
34/513 • Number of events 40 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.3%
177/516 • Number of events 177 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
39.6%
203/513 • Number of events 270 • Solicited AEs were collected during 4-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to study end [6 months after last vaccination]).
Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurence of each event, as pre-specified in Statistical Analysis Plan.
|
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