Trial Outcomes & Findings for A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine (NCT NCT05047770)
NCT ID: NCT05047770
Last Updated: 2023-11-13
Results Overview
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2013 participants
Primary outcome timeframe
At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)
Results posted on
2023-11-13
Participant Flow
The study was conducted at 47 centers in the United States.
Out of 2013 participants enrolled in the study, 468 were screen failures and 1545 were randomized to study groups. Out of 1545 randomized participants, only 1534 received at least 1 dose of study vaccine, were included in the Exposed Set and started the study.
Participant milestones
| Measure |
HZ/suSeq Group
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
FluD-QIVSeq Group
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
|
FluD-QIVCoAd Group
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
272
|
267
|
497
|
498
|
|
Overall Study
COMPLETED
|
249
|
252
|
478
|
473
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
19
|
25
|
Reasons for withdrawal
| Measure |
HZ/suSeq Group
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
FluD-QIVSeq Group
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
|
FluD-QIVCoAd Group
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
10
|
6
|
12
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
12
|
13
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
Baseline characteristics by cohort
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
FluD-QIVSeq Group
n=497 Participants
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
|
FluD-QIVCoAd Group
n=498 Participants
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
|
Total
n=1534 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 8.38 • n=5 Participants
|
62.5 Years
STANDARD_DEVIATION 8.77 • n=7 Participants
|
48.7 Years
STANDARD_DEVIATION 16.10 • n=5 Participants
|
49.5 Years
STANDARD_DEVIATION 15.45 • n=4 Participants
|
55.7 Years
STANDARD_DEVIATION 12.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
880 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
654 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
247 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
435 Participants
n=4 Participants
|
1368 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
MIXED ORIGIN
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
OTHER, UNSPECIFIED
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)Population: HZ/su Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-HZ/su Dose 2, and with immunogenicity data available for the specified analysis at the specified time point post-HZ/su Dose 2.
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
HZ/suSeq Group
n=228 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=230 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-glycoprotein E (gE) Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios
|
47434.82 mIU/mL
Interval 43306.87 to 51956.24
|
47599.82 mIU/mL
Interval 43960.57 to 51540.33
|
PRIMARY outcome
Timeframe: At 1 month post-mRNA-1273 booster dose administration (Week 4 for both HZ/suSeq and HZ/suCoAd groups)Population: mRNA-1273 Per Protocol Set (for HZ/su groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-mRNA-1273 dose, and with immunogenicity data available for the specified analysis at the specified time point post-mRNA-1273 dose.
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in arbitrary units per milliliter (AU/mL).
Outcome measures
| Measure |
HZ/suSeq Group
n=247 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=247 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios
|
618638.92 AU/mL
Interval 526014.86 to 727572.81
|
567728.74 AU/mL
Interval 513530.08 to 627647.61
|
PRIMARY outcome
Timeframe: At 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time point post-Flu D-QIV dose.
Antibody titers against the 4 influenza strains (A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage) included in the FLU D-QIV vaccine were determined by hemagglutination inhibition and expressed as GMTs.
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-hemagglutinin Inhibition (HI) Antibody Titers Expressed as Geometric Mean Titers (GMTs) Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
A/H1N1
|
598.62 Titers
Interval 535.51 to 669.17
|
577.77 Titers
Interval 517.8 to 644.68
|
|
Anti-hemagglutinin Inhibition (HI) Antibody Titers Expressed as Geometric Mean Titers (GMTs) Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
A/H3N2
|
268.32 Titers
Interval 242.17 to 297.3
|
280.26 Titers
Interval 252.47 to 311.11
|
|
Anti-hemagglutinin Inhibition (HI) Antibody Titers Expressed as Geometric Mean Titers (GMTs) Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
B/Victoria lineage
|
48.00 Titers
Interval 43.19 to 53.34
|
47.21 Titers
Interval 42.47 to 52.49
|
|
Anti-hemagglutinin Inhibition (HI) Antibody Titers Expressed as Geometric Mean Titers (GMTs) Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
B/Yamagata lineage
|
55.30 Titers
Interval 49.64 to 61.61
|
48.74 Titers
Interval 43.83 to 54.21
|
PRIMARY outcome
Timeframe: At 1 month post-mRNA-1273 booster dose administration (Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups)Population: mRNA-1273 Per Protocol Set (for Flu D-QIV groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time point post-mRNA-1273 dose.
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in AU/mL.
Outcome measures
| Measure |
HZ/suSeq Group
n=464 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=458 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
|
482604.31 AU/mL
Interval 423492.63 to 549966.87
|
494646.32 AU/mL
Interval 458286.58 to 533890.79
|
SECONDARY outcome
Timeframe: At 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time point post-Flu D-QIV dose.
A participant seroconverted for anti-HI antibodies against the 4 influenza strains is defined as a participant having either a pre-vaccination HI titer below (\<) 1:10 and a post-vaccination HI titer greater than or equal to (≥) 1:40, or a pre-vaccination HI titer ≥ 1:10 and at least a 4 fold greater post-vaccination HI titer. The 4 influenza strains assessed were A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Differences
A/H1N1
|
73.7 Percentage of participants
Interval 69.4 to 77.7
|
73.1 Percentage of participants
Interval 68.8 to 77.1
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Differences
A/H3N2
|
48.7 Percentage of participants
Interval 44.0 to 53.4
|
50.0 Percentage of participants
Interval 45.3 to 54.7
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Differences
B/Victoria lineage
|
28.9 Percentage of participants
Interval 24.7 to 33.3
|
28.8 Percentage of participants
Interval 24.7 to 33.2
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Differences
B/Yamagata lineage
|
22.0 Percentage of participants
Interval 18.3 to 26.1
|
23.6 Percentage of participants
Interval 19.8 to 27.7
|
SECONDARY outcome
Timeframe: At pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group) and at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)Population: HZ/su Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-HZ/su Dose 2, and with immunogenicity data available for the specified analysis at the specified time points pre-vaccination and post-HZ/su Dose 2.
A participant seropositive for anti-gE antibodies is defined as a participant whose anti-gE antibody concentration was greater than or equal to the assay cut-off value (97 mIU/mL).
Outcome measures
| Measure |
HZ/suSeq Group
n=228 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=230 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants Seropositive for Anti-gE Antibodies in HZ/suSeq and HZ/suCoAd Groups
Pre-vaccination
|
96.9 Percentage of participants
Interval 93.8 to 98.8
|
98.3 Percentage of participants
Interval 95.6 to 99.5
|
|
Percentage of Participants Seropositive for Anti-gE Antibodies in HZ/suSeq and HZ/suCoAd Groups
1 month post-HZ/su Dose 2
|
100 Percentage of participants
Interval 98.4 to 100.0
|
100 Percentage of participants
Interval 98.4 to 100.0
|
SECONDARY outcome
Timeframe: At pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group) and at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)Population: HZ/su Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-HZ/su Dose 2, and with immunogenicity data available for the specified analysis at the specified time points pre-vaccination and post-HZ/su Dose 2.
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Outcome measures
| Measure |
HZ/suSeq Group
n=228 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=230 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-gE Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups
Pre-vaccination
|
1243.79 mIU/mL
Interval 1060.96 to 1458.12
|
1361.01 mIU/mL
Interval 1195.56 to 1549.36
|
|
Anti-gE Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups
1 month post-HZ/su Dose 2
|
47434.82 mIU/mL
Interval 43306.87 to 51956.24
|
47599.82 mIU/mL
Interval 43960.57 to 51540.33
|
SECONDARY outcome
Timeframe: At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)Population: HZ/su Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-HZ/su Dose 2, and with immunogenicity data available for the specified analysis at the specified time point post-HZ/su Dose 2.
A participant with vaccine response for anti-gE is defined as a participant with: * At least a 4-fold greater post-dose anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for participants who were seropositive at pre-vaccination, or, * At least a 4-fold greater post-dose anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for participants who were seronegative at pre-vaccination.
Outcome measures
| Measure |
HZ/suSeq Group
n=228 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=230 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants With a Vaccine Response for Anti-gE in HZ/suSeq and HZ/suCoAd Groups
|
96.9 Percentage of participants
Interval 93.8 to 98.8
|
97.4 Percentage of participants
Interval 94.4 to 99.0
|
SECONDARY outcome
Timeframe: At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group) compared to pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group)Population: HZ/su Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-HZ/su Dose 2, and with immunogenicity data available for the specified analysis at the specified time points pre-vaccination and post-HZ/su Dose 2.
MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-gE antibody concentration to the pre-vaccination anti-gE antibody concentration.
Outcome measures
| Measure |
HZ/suSeq Group
n=228 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=230 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-gE in HZ/suSeq and HZ/suCoAd Groups
|
38.14 Ratio
Interval 32.02 to 45.42
|
34.97 Ratio
Interval 30.37 to 40.27
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 1) and at 1 month post-mRNA-1273 booster dose administration (Week 4 for both HZ/suSeq and HZ/suCoAd groups)Population: mRNA-1273 Per Protocol Set (for HZ/su groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-mRNA-1273 dose, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-mRNA-1273 dose.
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in AU/mL.
Outcome measures
| Measure |
HZ/suSeq Group
n=247 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=247 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups
Pre-vaccination
|
33138.45 AU/mL
Interval 28222.94 to 38910.09
|
34223.23 AU/mL
Interval 29039.32 to 40332.54
|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups
1 month post-mRNA-1273 booster dose
|
618638.92 AU/mL
Interval 526014.86 to 727572.81
|
567728.74 AU/mL
Interval 513530.08 to 627647.61
|
SECONDARY outcome
Timeframe: At pre-vaccination (Day 1) and at 1 month post-mRNA-1273 booster dose administration (Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups)Population: mRNA-1273 Per Protocol Set(for Flu D-QIV groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-mRNA-1273 dose.
Anti-S antibody concentrations were determined by Multiplex Electrochemiluminescence assay and expressed as GMCs in AU/mL.
Outcome measures
| Measure |
HZ/suSeq Group
n=464 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=458 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups
Pre-vaccination
|
32654.66 AU/mL
Interval 28833.08 to 36982.76
|
33635.52 AU/mL
Interval 29510.93 to 38336.58
|
|
Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups
1 month post-mRNA-1273 booster dose
|
482604.31 AU/mL
Interval 423492.63 to 549966.87
|
494646.32 AU/mL
Interval 458286.58 to 533890.79
|
SECONDARY outcome
Timeframe: At 1 month post-mRNA-1273 booster dose administration (Week 4 for both HZ/suSeq and HZ/suCoAd groups) compared to pre-vaccination (Day 1)Population: mRNA-1273 Per Protocol Set (for HZ/su groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination up to blood sample collection post-mRNA-1273 dose, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-mRNA-1273 dose.
MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-S protein antibody concentration to the pre-vaccination anti-S protein antibody concentration.
Outcome measures
| Measure |
HZ/suSeq Group
n=247 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=247 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-S Protein in HZ/suSeq and HZ/suCoAd Groups
|
18.67 Ratio
Interval 15.22 to 22.9
|
16.59 Ratio
Interval 13.73 to 20.04
|
SECONDARY outcome
Timeframe: At 1 month post-mRNA-1273 booster dose administration (Week 4 for both FluD-QIVSeq and FluD-QIVCoAd groups) compared to pre-vaccination (Day 1)Population: mRNA-1273 Per Protocol Set(for Flu D-QIV groups) included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-mRNA-1273 dose.
MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-S protein antibody concentration to the pre-vaccination anti-S protein antibody concentration.
Outcome measures
| Measure |
HZ/suSeq Group
n=464 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=458 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-S Protein in FluD-QIVSeq and FluD-QIVCoAd Groups
|
14.78 Ratio
Interval 12.55 to 17.41
|
14.71 Ratio
Interval 12.87 to 16.81
|
SECONDARY outcome
Timeframe: At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-Flu D-QIV dose.
Antibody titers against the 4 influenza strains (A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage) included in the FLU D-QIV vaccine were determined by hemagglutination inhibition and expressed as GMTs.
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Yamagata lineage, at Pre-vaccination
|
23.42 Titers
Interval 20.92 to 26.23
|
20.49 Titers
Interval 18.38 to 22.85
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H1N1, at Pre-vaccination
|
65.18 Titers
Interval 57.38 to 74.04
|
61.86 Titers
Interval 54.18 to 70.64
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H1N1, at 1 month post-Flu D-QIV dose
|
598.62 Titers
Interval 535.51 to 669.17
|
577.77 Titers
Interval 517.8 to 644.68
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H3N2, at Pre-vaccination
|
70.93 Titers
Interval 62.14 to 80.97
|
66.30 Titers
Interval 58.08 to 75.68
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H3N2, at 1 month post-Flu D-QIV dose
|
268.32 Titers
Interval 242.17 to 297.3
|
280.26 Titers
Interval 252.47 to 311.11
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Victoria lineage, at Pre-vaccination
|
17.92 Titers
Interval 16.11 to 19.93
|
17.48 Titers
Interval 15.78 to 19.37
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Victoria lineage, at 1 month post-Flu D-QIV dose
|
48.00 Titers
Interval 43.19 to 53.34
|
47.21 Titers
Interval 42.47 to 52.49
|
|
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Yamagata lineage, at 1 month post-Flu D-QIV dose
|
55.30 Titers
Interval 49.64 to 61.61
|
48.74 Titers
Interval 43.83 to 54.21
|
SECONDARY outcome
Timeframe: At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-Flu D-QIV dose.
A participant seroprotected for anti-HI antibodies against the 4 influenza strains included in the FluD-QIV vaccine is defined as a participant with a serum HI titer ≥ 1:40. The 4 influenza strains assessed were A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage. The age categories assessed were 18-64 and ≥ 65 years of age (YOA).
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, ≥65 YOA category, at 1 month post-Flu D-QIV dose
|
95.8 Percentage of participants
Interval 89.6 to 98.8
|
94.8 Percentage of participants
Interval 88.3 to 98.3
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, ≥65 YOA category, at Pre-vaccination
|
65.6 Percentage of participants
Interval 55.2 to 75.0
|
63.5 Percentage of participants
Interval 53.1 to 73.1
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, ≥65 YOA category, at 1 month post-Flu D-QIV dose
|
91.7 Percentage of participants
Interval 84.2 to 96.3
|
92.7 Percentage of participants
Interval 85.6 to 97.0
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, ≥65 YOA category, at Pre-vaccination
|
63.5 Percentage of participants
Interval 53.1 to 73.1
|
60.4 Percentage of participants
Interval 49.9 to 70.3
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, overall, at Pre-vaccination
|
71.1 Percentage of participants
Interval 66.7 to 75.3
|
69.3 Percentage of participants
Interval 64.8 to 73.4
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, overall, at 1 month post-Flu D-QIV dose
|
98.9 Percentage of participants
Interval 97.4 to 99.6
|
98.5 Percentage of participants
Interval 96.9 to 99.4
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, overall, at Pre-vaccination
|
71.1 Percentage of participants
Interval 66.7 to 75.3
|
69.0 Percentage of participants
Interval 64.6 to 73.2
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, overall, at 1 month post-Flu D-QIV dose
|
96.9 Percentage of participants
Interval 94.9 to 98.3
|
95.7 Percentage of participants
Interval 93.4 to 97.3
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, overall, at Pre-vaccination
|
30.8 Percentage of participants
Interval 26.6 to 35.3
|
30.1 Percentage of participants
Interval 25.9 to 34.5
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, overall, at 1 month post-Flu D-QIV dose
|
63.2 Percentage of participants
Interval 58.6 to 67.7
|
64.7 Percentage of participants
Interval 60.2 to 69.1
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, overall, at Pre-vaccination
|
39.9 Percentage of participants
Interval 35.3 to 44.5
|
36.1 Percentage of participants
Interval 31.8 to 40.7
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, overall, at 1 month post-Flu D-QIV dose
|
68.3 Percentage of participants
Interval 63.8 to 72.5
|
65.6 Percentage of participants
Interval 61.1 to 69.9
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, 18-64 YOA category, at Pre-vaccination
|
73.2 Percentage of participants
Interval 68.3 to 77.7
|
71.6 Percentage of participants
Interval 66.7 to 76.2
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, 18-64 YOA category, at 1 month post-Flu D-QIV dose
|
99.7 Percentage of participants
Interval 98.5 to 100.0
|
99.5 Percentage of participants
Interval 98.0 to 99.9
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, 18-64 YOA category, at Pre-vaccination
|
72.6 Percentage of participants
Interval 67.7 to 77.2
|
70.5 Percentage of participants
Interval 65.5 to 75.1
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, 18-64 YOA category, at 1 month post-Flu D-QIV dose
|
98.3 Percentage of participants
Interval 96.4 to 99.4
|
96.4 Percentage of participants
Interval 94.0 to 98.1
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, 18-64 YOA category, at Pre-vaccination
|
29.3 Percentage of participants
Interval 24.7 to 34.3
|
31.4 Percentage of participants
Interval 26.7 to 36.4
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, 18-64 YOA category, at 1 month post-Flu D-QIV dose
|
64.2 Percentage of participants
Interval 59.0 to 69.2
|
66.9 Percentage of participants
Interval 61.9 to 71.7
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, 18-64 YOA category, at Pre-vaccination
|
44.7 Percentage of participants
Interval 39.5 to 50.0
|
38.5 Percentage of participants
Interval 33.5 to 43.7
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, 18-64 YOA category, at 1 month post-Flu D-QIV dose
|
75.1 Percentage of participants
Interval 70.3 to 79.5
|
69.9 Percentage of participants
Interval 65.0 to 74.6
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, ≥65 YOA category, at Pre-vaccination
|
36.5 Percentage of participants
Interval 26.9 to 46.9
|
25.0 Percentage of participants
Interval 16.7 to 34.9
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, ≥65 YOA category, at 1 month post-Flu D-QIV dose
|
59.4 Percentage of participants
Interval 48.9 to 69.3
|
56.3 Percentage of participants
Interval 45.7 to 66.4
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, ≥65 YOA category, at Pre-vaccination
|
21.9 Percentage of participants
Interval 14.1 to 31.5
|
27.1 Percentage of participants
Interval 18.5 to 37.1
|
|
Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, ≥65 YOA category, at 1 month post-Flu D-QIV dose
|
42.7 Percentage of participants
Interval 32.7 to 53.2
|
49.0 Percentage of participants
Interval 38.6 to 59.4
|
SECONDARY outcome
Timeframe: At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-Flu D-QIV dose.
A participant seropositive for anti-HI antibodies against the 4 influenza strains included in the FluD-QIV vaccine is defined as a participant with a serum HI titer ≥ 1:10. The 4 influenza strains assessed were A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Yamagata lineage, at 1 month post-Flu D-QIV dose
|
96.7 Percentage of participants
Interval 94.6 to 98.1
|
95.0 Percentage of participants
Interval 92.6 to 96.8
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H1N1, at Pre-vaccination
|
91.6 Percentage of participants
Interval 88.7 to 94.0
|
89.8 Percentage of participants
Interval 86.7 to 92.4
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H1N1, at 1 month post-Flu D-QIV dose
|
99.8 Percentage of participants
Interval 98.8 to 100.0
|
99.8 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H3N2, at Pre-vaccination
|
94.5 Percentage of participants
Interval 92.0 to 96.4
|
92.6 Percentage of participants
Interval 89.9 to 94.8
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H3N2, at 1 month post-Flu D-QIV dose
|
99.8 Percentage of participants
Interval 98.8 to 100.0
|
99.4 Percentage of participants
Interval 98.1 to 99.9
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Victoria lineage, at Pre-vaccination
|
70.7 Percentage of participants
Interval 66.3 to 74.9
|
72.1 Percentage of participants
Interval 67.7 to 76.1
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Victoria lineage, at 1 month post-Flu D-QIV dose
|
94.9 Percentage of participants
Interval 92.5 to 96.8
|
95.2 Percentage of participants
Interval 92.9 to 97.0
|
|
Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Yamagata lineage, at Pre-vaccination
|
78.4 Percentage of participants
Interval 74.3 to 82.1
|
74.7 Percentage of participants
Interval 70.5 to 78.6
|
SECONDARY outcome
Timeframe: At 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group) compared to pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-Flu D-QIV dose.
MGI is defined as the geometric mean of the within participant ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer. The 4 influenza strains assessed were A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for Anti-HI Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H1N1
|
9.20 Ratio
Interval 8.02 to 10.56
|
9.38 Ratio
Interval 8.13 to 10.82
|
|
Mean Geometric Increase (MGI) for Anti-HI Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
A/H3N2
|
3.78 Ratio
Interval 3.38 to 4.23
|
4.23 Ratio
Interval 3.75 to 4.76
|
|
Mean Geometric Increase (MGI) for Anti-HI Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Victoria lineage
|
2.68 Ratio
Interval 2.42 to 2.96
|
2.70 Ratio
Interval 2.44 to 2.99
|
|
Mean Geometric Increase (MGI) for Anti-HI Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
B/Yamagata lineage
|
2.36 Ratio
Interval 2.16 to 2.58
|
2.38 Ratio
Interval 2.18 to 2.6
|
SECONDARY outcome
Timeframe: At 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group) compared to pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group)Population: Flu D-QIV Per Protocol Set included all participants who met all eligibility criteria, received all doses as per assignment, for whom administration site of study vaccine was known, who did not receive any other prohibited concomitant intervention, did not meet any of the criteria for elimination during the study through the last blood sample for the group, and with immunogenicity data available for the specified analysis at the specified time points pre- and post-Flu D-QIV dose.
A participant seroconverted for anti-HI antibodies against the 4 influenza strains is defined as a participant having either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40, or a pre-vaccination HI titer ≥ 1:10 and at least a 4 fold greater post-vaccination HI titer. The 4 influenza strains assessed were A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage. The age categories assessed were 18-64 and ≥65 years of age (YOA).
Outcome measures
| Measure |
HZ/suSeq Group
n=454 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=462 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, overall
|
73.7 Percentage of participants
Interval 69.4 to 77.7
|
73.1 Percentage of participants
Interval 68.8 to 77.1
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, overall
|
48.7 Percentage of participants
Interval 44.0 to 53.4
|
50.0 Percentage of participants
Interval 45.3 to 54.7
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, overall
|
28.9 Percentage of participants
Interval 24.7 to 33.3
|
28.8 Percentage of participants
Interval 24.7 to 33.2
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, overall
|
22.0 Percentage of participants
Interval 18.3 to 26.1
|
23.6 Percentage of participants
Interval 19.8 to 27.7
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, 18-64 YOA category
|
73.7 Percentage of participants
Interval 68.9 to 78.2
|
75.3 Percentage of participants
Interval 70.6 to 79.7
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, 18-64 YOA category
|
49.7 Percentage of participants
Interval 44.4 to 55.0
|
50.8 Percentage of participants
Interval 45.6 to 56.1
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, 18-64 YOA category
|
31.3 Percentage of participants
Interval 26.5 to 36.4
|
29.5 Percentage of participants
Interval 24.9 to 34.5
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, 18-64 YOA category
|
23.2 Percentage of participants
Interval 18.9 to 27.9
|
24.6 Percentage of participants
Interval 20.3 to 29.3
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H1N1, ≥65 YOA category
|
73.7 Percentage of participants
Interval 63.6 to 82.2
|
64.6 Percentage of participants
Interval 54.2 to 74.1
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
A/H3N2, ≥65 YOA category
|
44.8 Percentage of participants
Interval 34.6 to 55.3
|
46.9 Percentage of participants
Interval 36.6 to 57.3
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Victoria lineage, ≥65 YOA category
|
19.8 Percentage of participants
Interval 12.4 to 29.2
|
26.0 Percentage of participants
Interval 17.6 to 36.0
|
|
Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category
B/Yamagata lineage, ≥65 YOA category
|
17.7 Percentage of participants
Interval 10.7 to 26.8
|
19.8 Percentage of participants
Interval 12.4 to 29.2
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)Population: The HZ/su and mRNA-1273 Exposed set (for solicited safety analysis) included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented and with the electronic diary completed post-each vaccination.
The assessed solicited local AEs included axillary (underarm) swelling or tenderness, pain, pruritus, redness and swelling. Axillary swelling or tenderness was solicited for all participants and not restricted to mRNA-1273 recipients as was originally planned per protocol. Pruritus was solicited for all participants and not restricted to HZ/su recipients as was originally planned per protocol.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary (underarm) Swelling or Tenderness, Across doses
|
15.1 Percentage of participants
Interval 11.0 to 19.9
|
15.4 Percentage of participants
Interval 11.3 to 20.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, Across doses
|
81.6 Percentage of participants
Interval 76.5 to 86.0
|
80.9 Percentage of participants
Interval 75.7 to 85.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, Across doses
|
25.0 Percentage of participants
Interval 20.0 to 30.6
|
22.1 Percentage of participants
Interval 17.3 to 27.6
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, Across doses
|
17.6 Percentage of participants
Interval 13.3 to 22.7
|
13.5 Percentage of participants
Interval 9.6 to 18.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, Across doses
|
8.8 Percentage of participants
Interval 5.7 to 12.8
|
9.7 Percentage of participants
Interval 6.5 to 13.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary Swelling or Tenderness, post-mRNA-1273 booster dose
|
7.0 Percentage of participants
Interval 4.3 to 10.7
|
7.1 Percentage of participants
Interval 4.3 to 10.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, post-mRNA-1273 booster dose
|
61.8 Percentage of participants
Interval 55.7 to 67.6
|
63.7 Percentage of participants
Interval 57.6 to 69.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, post-mRNA-1273 booster dose
|
10.7 Percentage of participants
Interval 7.3 to 15.0
|
10.9 Percentage of participants
Interval 7.4 to 15.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, post-mRNA-1273 booster dose
|
4.0 Percentage of participants
Interval 2.0 to 7.1
|
3.7 Percentage of participants
Interval 1.8 to 6.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, post-mRNA-1273 booster dose
|
3.7 Percentage of participants
Interval 1.8 to 6.7
|
3.4 Percentage of participants
Interval 1.6 to 6.3
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary Swelling or Tenderness, post-HZ/su Dose 1
|
6.5 Percentage of participants
Interval 3.8 to 10.2
|
6.0 Percentage of participants
Interval 3.5 to 9.5
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, post-HZ/su Dose 1
|
64.1 Percentage of participants
Interval 58.0 to 69.9
|
70.8 Percentage of participants
Interval 64.9 to 76.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, post-HZ/su Dose 1
|
10.7 Percentage of participants
Interval 7.2 to 15.1
|
9.0 Percentage of participants
Interval 5.8 to 13.1
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, post-HZ/su Dose 1
|
6.5 Percentage of participants
Interval 3.8 to 10.2
|
5.2 Percentage of participants
Interval 2.9 to 8.6
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, post-HZ/su Dose 1
|
2.7 Percentage of participants
Interval 1.1 to 5.4
|
4.1 Percentage of participants
Interval 2.1 to 7.3
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary Swelling or Tenderness, post-HZ/su Dose 2
|
5.8 Percentage of participants
Interval 3.3 to 9.4
|
5.8 Percentage of participants
Interval 3.3 to 9.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, post-HZ/su Dose 2
|
58.5 Percentage of participants
Interval 52.3 to 64.6
|
59.1 Percentage of participants
Interval 52.9 to 65.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, post-HZ/su Dose 2
|
12.8 Percentage of participants
Interval 9.0 to 17.5
|
13.2 Percentage of participants
Interval 9.3 to 18.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, post-HZ/su Dose 2
|
11.2 Percentage of participants
Interval 7.7 to 15.7
|
9.3 Percentage of participants
Interval 6.1 to 13.6
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, post-HZ/su Dose 2
|
5.0 Percentage of participants
Interval 2.7 to 8.5
|
5.4 Percentage of participants
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)Population: The Flu D-QIV and mRNA-1273 Exposed set (for solicited safety analysis) included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented and with the electronic diary completed post-each vaccination.
The assessed solicited local AEs included axillary (underarm) swelling or tenderness, pain, pruritus, redness and swelling. Axillary swelling or tenderness was solicited for all participants and not restricted to mRNA-1273 recipients as was originally planned per protocol. Pruritus was solicited for all participants and not restricted to HZ/su recipients as was originally planned per protocol.
Outcome measures
| Measure |
HZ/suSeq Group
n=496 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=497 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary (underarm) Swelling or Tenderness, Across doses
|
20.0 Percentage of participants
Interval 16.5 to 23.8
|
14.3 Percentage of participants
Interval 11.3 to 17.7
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, Across doses
|
77.8 Percentage of participants
Interval 73.9 to 81.4
|
74.6 Percentage of participants
Interval 70.6 to 78.4
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, Across doses
|
13.9 Percentage of participants
Interval 11.0 to 17.3
|
13.9 Percentage of participants
Interval 11.0 to 17.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, Across doses
|
7.9 Percentage of participants
Interval 5.7 to 10.6
|
5.4 Percentage of participants
Interval 3.6 to 7.8
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, Across doses
|
6.5 Percentage of participants
Interval 4.5 to 9.0
|
6.0 Percentage of participants
Interval 4.1 to 8.5
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary Swelling or Tenderness, post-mRNA-1273 booster dose
|
16.3 Percentage of participants
Interval 13.2 to 19.9
|
12.5 Percentage of participants
Interval 9.7 to 15.7
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, post-mRNA-1273 booster dose
|
75.8 Percentage of participants
Interval 71.8 to 79.5
|
71.8 Percentage of participants
Interval 67.7 to 75.7
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, post-mRNA-1273 booster dose
|
12.1 Percentage of participants
Interval 9.4 to 15.3
|
11.9 Percentage of participants
Interval 9.2 to 15.0
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, post-mRNA-1273 booster dose
|
7.1 Percentage of participants
Interval 5.0 to 9.7
|
4.8 Percentage of participants
Interval 3.1 to 7.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, post-mRNA-1273 booster dose
|
6.0 Percentage of participants
Interval 4.1 to 8.5
|
5.6 Percentage of participants
Interval 3.8 to 8.0
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Axillary Swelling or Tenderness, post-Flu D-QIV dose
|
5.7 Percentage of participants
Interval 3.8 to 8.2
|
6.6 Percentage of participants
Interval 4.6 to 9.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pain, post-Flu D-QIV dose
|
30.6 Percentage of participants
Interval 26.6 to 34.9
|
48.1 Percentage of participants
Interval 43.6 to 52.6
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Pruritus, post-Flu D-QIV dose
|
4.5 Percentage of participants
Interval 2.8 to 6.7
|
3.8 Percentage of participants
Interval 2.3 to 5.9
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Redness, post-Flu D-QIV dose
|
1.8 Percentage of participants
Interval 0.8 to 3.5
|
0.8 Percentage of participants
Interval 0.2 to 2.0
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs)
Swelling, post-Flu D-QIV dose
|
1.0 Percentage of participants
Interval 0.3 to 2.4
|
1.2 Percentage of participants
Interval 0.4 to 2.6
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)Population: The HZ/su and mRNA-1273 Exposed set (for solicited safety analysis) included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented and with the electronic diary completed post-each vaccination. Here, 'number analyzed' = participants with available data for each specified category.
The assessed solicited systemic AEs included abdominal pain, arthralgia, chills, diarrhea, fatigue, fever, gastrointestinal symptoms, headache, myalgia, nausea and vomiting. Fever is defined as temperature ≥ 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F) by any route. The preferred location for measuring temperature was the oral route.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, Across doses
|
11.0 Percentage of participants
Interval 7.6 to 15.4
|
12.4 Percentage of participants
Interval 8.7 to 16.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, Across doses
|
37.5 Percentage of participants
Interval 31.7 to 43.5
|
40.8 Percentage of participants
Interval 34.9 to 47.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, Across doses
|
39.0 Percentage of participants
Interval 33.1 to 45.0
|
40.1 Percentage of participants
Interval 34.1 to 46.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, Across doses
|
20.6 Percentage of participants
Interval 15.9 to 25.9
|
19.5 Percentage of participants
Interval 14.9 to 24.7
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, Across doses
|
56.3 Percentage of participants
Interval 50.1 to 62.2
|
60.3 Percentage of participants
Interval 54.2 to 66.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, Across doses
|
10.7 Percentage of participants
Interval 7.3 to 15.0
|
13.1 Percentage of participants
Interval 9.3 to 17.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, Across doses
|
34.9 Percentage of participants
Interval 29.3 to 40.9
|
34.1 Percentage of participants
Interval 28.4 to 40.1
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, Across doses
|
46.3 Percentage of participants
Interval 40.3 to 52.4
|
51.3 Percentage of participants
Interval 45.1 to 57.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, Across doses
|
65.4 Percentage of participants
Interval 59.5 to 71.1
|
72.7 Percentage of participants
Interval 66.9 to 77.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, Across doses
|
18.8 Percentage of participants
Interval 14.3 to 23.9
|
16.9 Percentage of participants
Interval 12.6 to 21.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, Across doses
|
2.9 Percentage of participants
Interval 1.3 to 5.7
|
3.7 Percentage of participants
Interval 1.8 to 6.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-HZ/su Dose 1
|
2.7 Percentage of participants
Interval 1.1 to 5.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-HZ/su Dose 1
|
19.1 Percentage of participants
Interval 14.5 to 24.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-HZ/su Dose 1
|
14.9 Percentage of participants
Interval 10.8 to 19.8
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-HZ/su Dose 1
|
6.9 Percentage of participants
Interval 4.1 to 10.6
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-HZ/su Dose 1
|
32.1 Percentage of participants
Interval 26.5 to 38.1
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-HZ/su Dose 1
|
3.8 Percentage of participants
Interval 1.8 to 6.9
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-HZ/su Dose 1
|
12.6 Percentage of participants
Interval 8.8 to 17.2
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-HZ/su Dose 1
|
21.4 Percentage of participants
Interval 16.6 to 26.8
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-HZ/su Dose 1
|
37.8 Percentage of participants
Interval 31.9 to 44.0
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-HZ/su Dose 1
|
6.5 Percentage of participants
Interval 3.8 to 10.2
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-HZ/su Dose 1
|
0.0 Percentage of participants
Interval 0.0 to 1.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-HZ/su Dose 2
|
3.5 Percentage of participants
Interval 1.6 to 6.5
|
6.6 Percentage of participants
Interval 3.9 to 10.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-HZ/su Dose 2
|
20.9 Percentage of participants
Interval 16.1 to 26.4
|
23.3 Percentage of participants
Interval 18.3 to 29.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-HZ/su Dose 2
|
21.7 Percentage of participants
Interval 16.8 to 27.2
|
23.3 Percentage of participants
Interval 18.3 to 29.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-HZ/su Dose 2
|
8.5 Percentage of participants
Interval 5.4 to 12.6
|
10.5 Percentage of participants
Interval 7.0 to 14.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-HZ/su Dose 2
|
32.9 Percentage of participants
Interval 27.2 to 39.0
|
37.7 Percentage of participants
Interval 31.8 to 44.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-HZ/su Dose 2
|
3.9 Percentage of participants
Interval 1.9 to 7.0
|
4.3 Percentage of participants
Interval 2.2 to 7.5
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-HZ/su Dose 2
|
17.1 Percentage of participants
Interval 12.7 to 22.2
|
19.5 Percentage of participants
Interval 14.8 to 24.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-HZ/su Dose 2
|
28.3 Percentage of participants
Interval 22.9 to 34.2
|
31.9 Percentage of participants
Interval 26.3 to 38.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-HZ/su Dose 2
|
41.9 Percentage of participants
Interval 35.8 to 48.1
|
43.6 Percentage of participants
Interval 37.4 to 49.9
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-HZ/su Dose 2
|
8.1 Percentage of participants
Interval 5.1 to 12.2
|
9.7 Percentage of participants
Interval 6.4 to 14.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-HZ/su Dose 2
|
1.6 Percentage of participants
Interval 0.4 to 3.9
|
1.2 Percentage of participants
Interval 0.2 to 3.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-mRNA-1273 booster dose
|
5.9 Percentage of participants
Interval 3.4 to 9.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-mRNA-1273 booster dose
|
22.4 Percentage of participants
Interval 17.6 to 27.9
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-mRNA-1273 booster dose
|
19.5 Percentage of participants
Interval 14.9 to 24.7
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-mRNA-1273 booster dose
|
12.1 Percentage of participants
Interval 8.5 to 16.6
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-mRNA-1273 booster dose
|
36.4 Percentage of participants
Interval 30.7 to 42.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-mRNA-1273 booster dose
|
5.1 Percentage of participants
Interval 2.8 to 8.5
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-mRNA-1273 booster dose
|
21.0 Percentage of participants
Interval 16.3 to 26.3
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-mRNA-1273 booster dose
|
29.4 Percentage of participants
Interval 24.1 to 35.2
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-mRNA-1273 booster dose
|
45.6 Percentage of participants
Interval 39.6 to 51.7
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-mRNA-1273 booster dose
|
9.9 Percentage of participants
Interval 6.6 to 14.1
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-mRNA-1273 booster dose
|
1.5 Percentage of participants
Interval 0.4 to 3.7
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
7.9 Percentage of participants
Interval 4.9 to 11.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
30.3 Percentage of participants
Interval 24.9 to 36.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
31.5 Percentage of participants
Interval 25.9 to 37.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
13.5 Percentage of participants
Interval 9.6 to 18.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
51.7 Percentage of participants
Interval 45.5 to 57.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
10.1 Percentage of participants
Interval 6.8 to 14.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
24.0 Percentage of participants
Interval 19.0 to 29.6
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
39.0 Percentage of participants
Interval 33.1 to 45.1
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
64.0 Percentage of participants
Interval 58.0 to 69.8
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
10.1 Percentage of participants
Interval 6.8 to 14.4
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
3.0 Percentage of participants
Interval 1.3 to 5.8
|
SECONDARY outcome
Timeframe: Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)Population: The Flu D-QIV and mRNA-1273 Exposed set (for solicited safety analysis) included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented and with the electronic diary completed post-each vaccination. Here, 'number analyzed' = participants with available data for each specified category.
The assessed solicited systemic AEs included abdominal pain, arthralgia, chills, diarrhea, fatigue, fever, gastrointestinal symptoms, headache, myalgia, nausea and vomiting. Fever is defined as temperature ≥ 38.0°C/100.4°F by any route. The preferred location for measuring temperature was the oral route.
Outcome measures
| Measure |
HZ/suSeq Group
n=496 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=497 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, Across doses
|
10.5 Percentage of participants
Interval 7.9 to 13.5
|
6.6 Percentage of participants
Interval 4.6 to 9.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, Across doses
|
30.8 Percentage of participants
Interval 26.8 to 35.1
|
29.8 Percentage of participants
Interval 25.8 to 34.0
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, Across doses
|
33.1 Percentage of participants
Interval 28.9 to 37.4
|
29.2 Percentage of participants
Interval 25.2 to 33.4
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, Across doses
|
24.0 Percentage of participants
Interval 20.3 to 28.0
|
16.1 Percentage of participants
Interval 13.0 to 19.6
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, Across doses
|
63.7 Percentage of participants
Interval 59.3 to 67.9
|
57.7 Percentage of participants
Interval 53.3 to 62.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, Across doses
|
6.0 Percentage of participants
Interval 4.1 to 8.5
|
5.8 Percentage of participants
Interval 3.9 to 8.3
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, Across doses
|
39.5 Percentage of participants
Interval 35.2 to 44.0
|
27.8 Percentage of participants
Interval 23.9 to 31.9
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, Across doses
|
51.0 Percentage of participants
Interval 46.5 to 55.5
|
46.7 Percentage of participants
Interval 42.2 to 51.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, Across doses
|
64.3 Percentage of participants
Interval 59.9 to 68.5
|
58.8 Percentage of participants
Interval 54.3 to 63.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, Across doses
|
21.4 Percentage of participants
Interval 17.8 to 25.2
|
12.9 Percentage of participants
Interval 10.1 to 16.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, Across doses
|
3.2 Percentage of participants
Interval 1.9 to 5.2
|
1.6 Percentage of participants
Interval 0.7 to 3.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-FluD-QIV dose
|
2.9 Percentage of participants
Interval 1.6 to 4.7
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-FluD-QIV dose
|
6.7 Percentage of participants
Interval 4.7 to 9.3
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-FluD-QIV dose
|
6.3 Percentage of participants
Interval 4.3 to 8.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-FluD-QIV dose
|
10.6 Percentage of participants
Interval 8.0 to 13.7
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-FluD-QIV dose
|
19.6 Percentage of participants
Interval 16.2 to 23.4
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-FluD-QIV dose
|
0.8 Percentage of participants
Interval 0.2 to 2.1
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-FluD-QIV dose
|
15.9 Percentage of participants
Interval 12.8 to 19.5
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-FluD-QIV dose
|
19.6 Percentage of participants
Interval 16.2 to 23.4
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-FluD-QIV dose
|
14.5 Percentage of participants
Interval 11.5 to 17.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-FluD-QIV dose
|
5.7 Percentage of participants
Interval 3.8 to 8.2
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-FluD-QIV dose
|
1.0 Percentage of participants
Interval 0.3 to 2.4
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-mRNA-1273 booster dose
|
8.5 Percentage of participants
Interval 6.2 to 11.3
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-mRNA-1273 booster dose
|
28.6 Percentage of participants
Interval 24.7 to 32.8
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-mRNA-1273 booster dose
|
29.6 Percentage of participants
Interval 25.6 to 33.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-mRNA-1273 booster dose
|
16.5 Percentage of participants
Interval 13.4 to 20.1
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-mRNA-1273 booster dose
|
58.5 Percentage of participants
Interval 54.0 to 62.8
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-mRNA-1273 booster dose
|
5.2 Percentage of participants
Interval 3.5 to 7.6
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-mRNA-1273 booster dose
|
31.7 Percentage of participants
Interval 27.6 to 35.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-mRNA-1273 booster dose
|
46.2 Percentage of participants
Interval 41.7 to 50.7
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-mRNA-1273 booster dose
|
62.1 Percentage of participants
Interval 57.7 to 66.4
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-mRNA-1273 booster dose
|
19.2 Percentage of participants
Interval 15.8 to 22.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-mRNA-1273 booster dose
|
2.2 Percentage of participants
Interval 1.1 to 3.9
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Abdominal Pain, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
6.6 Percentage of participants
Interval 4.6 to 9.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Arthralgia, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
29.8 Percentage of participants
Interval 25.8 to 34.0
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Chills, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
29.2 Percentage of participants
Interval 25.2 to 33.4
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Diarrhea, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
16.1 Percentage of participants
Interval 13.0 to 19.6
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fatigue, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
57.7 Percentage of participants
Interval 53.3 to 62.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Fever, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
5.8 Percentage of participants
Interval 3.9 to 8.3
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Gastrointestinal Symptoms, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
27.8 Percentage of participants
Interval 23.9 to 31.9
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Headache, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
46.7 Percentage of participants
Interval 42.2 to 51.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Myalgia, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
58.8 Percentage of participants
Interval 54.3 to 63.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Nausea, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
12.9 Percentage of participants
Interval 10.1 to 16.1
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs)
Vomiting, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
1.6 Percentage of participants
Interval 0.7 to 3.1
|
SECONDARY outcome
Timeframe: Within 14 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)Population: The HZ/su and mRNA-1273 Exposed set (for unsolicited safety analysis) included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented and with unsolicited AEs data available for the specified duration post-vaccination. Here, 'number analyzed' = participants with available data for each specified category.
An unsolicited AE was defined as any AE that was either not included in the list of solicited events using a participant diary, or was included in the list of solicited events, but with an onset more than 7 days following administration of a study intervention.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, Across doses
|
31.6 Percentage of participants
Interval 26.1 to 37.5
|
28.8 Percentage of participants
Interval 23.5 to 34.7
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-HZ/su Dose 1
|
14.5 Percentage of participants
Interval 10.5 to 19.4
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-HZ/su Dose 2
|
10.1 Percentage of participants
Interval 6.7 to 14.4
|
14.8 Percentage of participants
Interval 10.7 to 19.7
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose
|
22.8 Percentage of participants
Interval 17.9 to 28.2
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose + HZ/su Dose 1
|
—
|
20.6 Percentage of participants
Interval 15.9 to 26.0
|
SECONDARY outcome
Timeframe: Within 14 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)Population: The Flu D-QIV and mRNA-1273 Exposed set (for unsolicited safety analysis) included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented and with unsolicited AEs data available for the specified duration post-vaccination. Here, 'number analyzed' = participants with available data for each specified category.
An unsolicited AE was defined as any AE that was either not included in the list of solicited events using a participant diary, or was included in the list of solicited events, but with an onset more than 7 days following administration of a study intervention.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, Across doses
|
35.2 Percentage of participants
Interval 31.0 to 39.6
|
25.1 Percentage of participants
Interval 21.3 to 29.2
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-FluD-QIV dose
|
16.9 Percentage of participants
Interval 13.7 to 20.6
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose
|
26.2 Percentage of participants
Interval 22.3 to 30.3
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
25.1 Percentage of participants
Interval 21.3 to 29.2
|
SECONDARY outcome
Timeframe: Within 30 days after each vaccine dose and across vaccine doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)Population: The HZ/su and mRNA-1273 Exposed set (for unsolicited safety analysis) included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented and with unsolicited AEs data available for the specified duration post-vaccination. Here, 'number analyzed' = participants with data available for each specified category.
An unsolicited AE was defined as any AE that was either not included in the list of solicited events using a participant diary, or was included in the list of solicited events, but with an onset more than 7 days following administration of a study intervention.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, Across doses
|
41.5 Percentage of participants
Interval 35.6 to 47.6
|
46.1 Percentage of participants
Interval 40.0 to 52.2
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-HZ/su Dose 1
|
25.2 Percentage of participants
Interval 20.1 to 30.9
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-HZ/su Dose 2
|
15.1 Percentage of participants
Interval 11.0 to 20.1
|
23.3 Percentage of participants
Interval 18.3 to 29.0
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose
|
25.0 Percentage of participants
Interval 20.0 to 30.6
|
—
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1237 booster dose + HZ/su Dose 1
|
—
|
37.1 Percentage of participants
Interval 31.3 to 43.2
|
SECONDARY outcome
Timeframe: Within 30 days after each vaccine dose and across vaccine doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)Population: The Flu D-QIV and mRNA-1273 Exposed set (for unsolicited safety analysis) included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented and with unsolicited AEs data available for the specified duration post-vaccination. Here, 'number analyzed' = participants with data available for each specified category.
An unsolicited AE was defined as any AE that was either not included in the list of solicited events using a participant diary, or was included in the list of solicited events, but with an onset more than 7 days following administration of a study intervention.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, Across doses
|
43.1 Percentage of participants
Interval 38.7 to 47.5
|
36.9 Percentage of participants
Interval 32.7 to 41.4
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-FluD-QIV dose
|
27.3 Percentage of participants
Interval 23.4 to 31.5
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose
|
29.6 Percentage of participants
Interval 25.6 to 33.8
|
—
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs)
Unsolicited AEs, post-mRNA-1273 booster dose + FluD-QIV dose
|
—
|
36.9 Percentage of participants
Interval 32.7 to 41.4
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each groupPopulation: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Serious Adverse Events (SAEs)
|
1.5 Percentage of participants
Interval 0.4 to 3.7
|
1.5 Percentage of participants
Interval 0.4 to 3.8
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Serious Adverse Events (SAEs)
|
1.8 Percentage of participants
Interval 0.6 to 4.2
|
2.2 Percentage of participants
Interval 0.8 to 4.8
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each groupPopulation: The Flu D-QIV and mRNA-1273 Exposed set included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented.
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Serious Adverse Events (SAEs)
|
0.2 Percentage of participants
Interval 0.0 to 1.1
|
0.2 Percentage of participants
Interval 0.0 to 1.1
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The Flu D-QIV and mRNA-1273 Exposed set included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented.
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Serious Adverse Events (SAEs)
|
1.4 Percentage of participants
Interval 0.6 to 2.9
|
0.4 Percentage of participants
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each groupPopulation: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
The assessed pIMDs included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Potential Immune Mediated Diseases (pIMDs)
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
The assessed pIMDs included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Potential Immune Mediated Diseases (pIMDs)
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each groupPopulation: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
AESIs were defined as medical concepts that may have been related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Adverse Events of Special Interest (AESIs)
|
1.1 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
AESIs were defined as medical concepts that may have been related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Adverse Events of Special Interest (AESIs)
|
1.1 Percentage of participants
|
0.7 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each groupPopulation: The Flu D-QIV and mRNA-1273 Exposed set included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented.
AESIs were defined as medical concepts that may have been related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Adverse Events of Special Interest (AESIs)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The Flu D-QIV and mRNA-1273 Exposed set included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented.
AESIs were defined as medical concepts that may have been related to COVID-19 or were of interest in COVID-19 vaccine safety surveillance.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Adverse Events of Special Interest (AESIs)
|
0.0 Percentage of participants
|
0.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
A suspected HZ episode is defined as a new unilateral rash accompanied by pain broadly defined to include allodynia, pruritus or other sensations without alternative diagnosis.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Clinically Suspected HZ Episodes
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The HZ/su and mRNA-1273 Exposed set included all participants in the HZ/su and mRNA-1273 booster cohort (HZ/suSeq and HZ/suCoAd groups) with at least 1 vaccine administration documented.
Primary Case Definition: Experienced at least TWO of following systemic symptoms: fever (temperature ≥38ºC), chills, myalgia, headache, sore throat, new olfactory \& taste disorder(s), OR at least ONE of following respiratory signs: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; AND must have at least one nasopharyngeal (NP) or nasal swab, or saliva or respiratory sample positive for SARS-CoV-2 by PCR. Secondary Case Definition: Following systemic symptoms: fever, or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea AND a positive NP or nasal swab, or saliva or respiratory sample for SARS-CoV-2 by PCR. Tertiary Case Definition: Documented COVID-19 diagnosis made by health care provider and not meeting the above case definitions.
Outcome measures
| Measure |
HZ/suSeq Group
n=272 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Meeting Case Definitions of COVID-19
Primary Case Definition
|
4.4 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Meeting Case Definitions of COVID-19
Secondary Case Definition
|
2.2 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Meeting Case Definitions of COVID-19
Tertiary Case Definition
|
0.7 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)Population: The Flu D-QIV and mRNA-1273 Exposed set included all participants in the Flu D-QIV and mRNA-1273 booster cohort (FluD-QIVSeq and FluD-QIVCoAd groups) with at least 1 vaccine administration documented.
Primary Case Definition: Experienced at least TWO of following systemic symptoms: fever (temperature ≥38ºC), chills, myalgia, headache, sore throat, new olfactory \& taste disorder(s), OR at least ONE of following respiratory signs: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; AND must have at least one nasopharyngeal (NP) or nasal swab, or saliva or respiratory sample positive for SARS-CoV-2 by PCR. Secondary Case Definition: Following systemic symptoms: fever, or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea AND a positive NP or nasal swab, or saliva or respiratory sample for SARS-CoV-2 by PCR. Tertiary Case Definition: Documented COVID-19 diagnosis made by health care provider and not meeting the above case definitions.
Outcome measures
| Measure |
HZ/suSeq Group
n=497 Participants
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=498 Participants
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
|---|---|---|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Meeting Case Definitions of COVID-19
Primary Case Definition
|
4.6 Percentage of participants
|
3.2 Percentage of participants
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Meeting Case Definitions of COVID-19
Secondary Case Definition
|
1.8 Percentage of participants
|
2.0 Percentage of participants
|
|
Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Meeting Case Definitions of COVID-19
Tertiary Case Definition
|
0.6 Percentage of participants
|
0.6 Percentage of participants
|
Adverse Events
HZ/suSeq Group
Serious events: 5 serious events
Other events: 248 other events
Deaths: 0 deaths
HZ/suCoAd Group
Serious events: 6 serious events
Other events: 243 other events
Deaths: 0 deaths
FluD-QIVSeq Group
Serious events: 7 serious events
Other events: 463 other events
Deaths: 0 deaths
FluD-QIVCoAd Group
Serious events: 2 serious events
Other events: 445 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HZ/suSeq Group
n=272 participants at risk
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 participants at risk
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
FluD-QIVSeq Group
n=497 participants at risk
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
|
FluD-QIVCoAd Group
n=498 participants at risk
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.37%
1/272 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.37%
1/272 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Seizure
|
0.37%
1/272 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.37%
1/272 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix adenoma
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Negative pressure pulmonary oedema
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Urosepsis
|
0.37%
1/272 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Number of events 1 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
Other adverse events
| Measure |
HZ/suSeq Group
n=272 participants at risk
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
|
HZ/suCoAd Group
n=267 participants at risk
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
|
FluD-QIVSeq Group
n=497 participants at risk
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
|
FluD-QIVCoAd Group
n=498 participants at risk
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
|
|---|---|---|---|---|
|
General disorders
Chills
|
42.6%
116/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
43.4%
116/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
36.0%
179/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
31.3%
156/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Injection site swelling
|
9.2%
25/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
9.7%
26/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
6.4%
32/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
6.0%
30/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Chest discomfort
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Injection site erythema
|
18.0%
49/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
13.5%
36/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
7.8%
39/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
5.4%
27/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Pyrexia
|
11.4%
31/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
13.5%
36/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
6.4%
32/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
5.8%
29/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Injection site pain
|
81.6%
222/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
80.9%
216/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
77.7%
386/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
74.5%
371/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Fatigue
|
57.7%
157/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
62.5%
167/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
66.8%
332/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
60.6%
302/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Oedema peripheral
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Pain
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Swelling face
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.5%
181/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
74.2%
198/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
66.4%
330/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
60.8%
303/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
42.3%
115/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
42.3%
113/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
33.8%
168/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
32.3%
161/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.75%
2/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Headache
|
51.8%
141/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
56.9%
152/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
57.1%
284/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
52.6%
262/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Migraine
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Anosmia
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Sciatica
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Syncope
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Thoracic outlet syndrome
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Tremor
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
68/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
26.6%
71/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
30.6%
152/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
25.1%
125/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Nausea
|
22.8%
62/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
19.9%
53/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
25.8%
128/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
18.7%
93/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
39/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
16.1%
43/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
13.9%
69/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
9.4%
47/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
12/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
4.5%
12/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
6.4%
32/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
3.8%
19/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Constipation
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
25.0%
68/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
22.1%
59/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
13.9%
69/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
13.9%
69/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
15.4%
42/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
15.7%
42/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
19.9%
99/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
14.5%
72/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
COVID-19
|
1.1%
3/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.9%
5/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.2%
6/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Urinary tract infection
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.9%
5/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.80%
4/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
5/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.8%
9/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Nasopharyngitis
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Bronchitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Tooth infection
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Administration site pustule
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Cellulitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Chronic sinusitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Ear infection
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Herpes zoster
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Influenza
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Laryngitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Laryngitis viral
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Nasal herpes
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Sinusitis
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.0%
5/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Fall
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
1.1%
3/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.75%
2/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.74%
2/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Dysuria
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Eye disorders
Cataract
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Eye disorders
Conjunctival haemorrhage
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Eye disorders
Vision blurred
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
SARS-CoV-2 test positive
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Vascular disorders
Hypotension
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.37%
1/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.37%
1/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Influenza like illness
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
General disorders
Tissue infiltration
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.60%
3/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Injury, poisoning and procedural complications
Trunk injury
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
Blood urine present
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Investigations
Liver function test increased
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Eye disorders
Eye pain
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Eye disorders
Pterygium
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Vascular disorders
Hypertension
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.40%
2/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/272 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/267 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.20%
1/497 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
0.00%
0/498 • Solicited local and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose).
|
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