Trial Outcomes & Findings for A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (NCT NCT06361875)
NCT ID: NCT06361875
Last Updated: 2026-08-04
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
908 participants
Primary outcome timeframe
Within 30 minutes after vaccine administration on Day 1
Results posted on
2026-08-04
Participant Flow
The study was conducted at 19 centers in 2 countries from 01 April 2024 to 09 June 2025. QIV mRNA= Quadrivalent influenza modified messenger ribonucleic acid vaccine; QIV-SD= Standard dose quadrivalent influenza vaccine; RIV4= Quadrivalent recombinant influenza vaccine; QIV-HD= High dose quadrivalent influenza vaccine.
A total of 908 participants were enrolled and randomized in the study. Randomization was stratified by cohort and age group (18 to 64 years and \>= 65 years). Participants were assigned to either QIV mRNA groups, QIV-SD, RIV4 or QIV-HD (only for participants aged 65 years and above) in a ratio of allocation between 2 groups as 1:1 or 1:2.
Participant milestones
| Measure |
QIV mRNA LNP 1: 30 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
QIV mRNA LNP 1: 96 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
121
|
119
|
120
|
120
|
27
|
75
|
119
|
119
|
60
|
|
Overall Study
COMPLETED
|
26
|
117
|
112
|
119
|
115
|
25
|
71
|
114
|
110
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
7
|
1
|
5
|
2
|
4
|
5
|
9
|
0
|
Reasons for withdrawal
| Measure |
QIV mRNA LNP 1: 30 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
QIV mRNA LNP 1: 96 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Protocol Deviation
|
0
|
2
|
2
|
0
|
1
|
0
|
1
|
2
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
0
|
3
|
2
|
1
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
1
|
0
|
0
|
2
|
1
|
2
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above
Baseline characteristics by cohort
| Measure |
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
QIV mRNA LNP 1: 96 mcg
n=121 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
Total
n=908 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 15.4 • n=20 Participants
|
57.9 years
STANDARD_DEVIATION 16.4 • n=20 Participants
|
55.8 years
STANDARD_DEVIATION 17.5 • n=40 Participants
|
57.5 years
STANDARD_DEVIATION 17.2 • n=6 Participants
|
55.6 years
STANDARD_DEVIATION 17.5 • n=7 Participants
|
56.0 years
STANDARD_DEVIATION 18.6 • n=13 Participants
|
56.2 years
STANDARD_DEVIATION 17.6 • n=6 Participants
|
57.2 years
STANDARD_DEVIATION 16.5 • n=6 Participants
|
57.0 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 4.50 • n=6 Participants
|
57.7 years
STANDARD_DEVIATION 16.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=20 Participants
|
64 Participants
n=20 Participants
|
70 Participants
n=40 Participants
|
63 Participants
n=6 Participants
|
63 Participants
n=7 Participants
|
15 Participants
n=13 Participants
|
36 Participants
n=6 Participants
|
65 Participants
n=6 Participants
|
59 Participants
n=5 Participants
|
32 Participants
n=6 Participants
|
480 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=20 Participants
|
57 Participants
n=20 Participants
|
49 Participants
n=40 Participants
|
57 Participants
n=6 Participants
|
57 Participants
n=7 Participants
|
12 Participants
n=13 Participants
|
39 Participants
n=6 Participants
|
54 Participants
n=6 Participants
|
60 Participants
n=5 Participants
|
28 Participants
n=6 Participants
|
428 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=6 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
17 Participants
n=6 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=13 Participants
|
9 Participants
n=6 Participants
|
14 Participants
n=6 Participants
|
16 Participants
n=5 Participants
|
9 Participants
n=6 Participants
|
111 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=20 Participants
|
104 Participants
n=20 Participants
|
104 Participants
n=40 Participants
|
99 Participants
n=6 Participants
|
104 Participants
n=7 Participants
|
24 Participants
n=13 Participants
|
63 Participants
n=6 Participants
|
101 Participants
n=6 Participants
|
99 Participants
n=5 Participants
|
50 Participants
n=6 Participants
|
776 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed Origin
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 30 minutes after vaccine administration on Day 1Population: The modified full analysis set (mFAS) included participants who had received the study vaccine.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) After Vaccine Administration
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine administration on Day 1Population: The mFAS included participants who had received the study vaccine.
An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. Solicited injection site reactions are reactions at and around the injection site of the vaccine observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions After Vaccine Administration
|
71 Participants
|
76 Participants
|
79 Participants
|
74 Participants
|
17 Participants
|
50 Participants
|
24 Participants
|
18 Participants
|
13 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after vaccine administration on Day 1Population: The mFAS included participants who had received the study vaccine.
An AR is any noxious and unintended response to a study vaccine related to any dose. Solicited systemic reactions are systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions After Vaccine Administration
|
58 Participants
|
71 Participants
|
73 Participants
|
60 Participants
|
18 Participants
|
48 Participants
|
21 Participants
|
17 Participants
|
16 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Within 28 days after vaccine administration on Day 1Population: The mFAS included participants who had received the study vaccine.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events After Vaccine Administration
|
30 Participants
|
26 Participants
|
26 Participants
|
32 Participants
|
11 Participants
|
20 Participants
|
15 Participants
|
14 Participants
|
10 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 180 days after vaccine administration on Day 1Population: The mFAS included participants who had received the study vaccine.
An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or emergency department.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs)
|
10 Participants
|
12 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
7 Participants
|
12 Participants
|
13 Participants
|
8 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 daysPopulation: The mFAS included participants who had received the study vaccine.
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is 1 of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. The AESIs was defined as anaphylactic reactions (including bronchospasms, and laryngeal spasms), Guillain-Barré syndrome, neuritis (including Bell's palsy), myocarditis, pericarditis, myopericarditis and vasculitis.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Any SAE
|
4 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
Any AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 8 days after vaccine administration on Day 1Population: The mFAS included participants who had received the study vaccine.
Blood samples were collected for the assessment of abnormal hematology and clinical chemistry parameters. Only participants with outside the normal range hematology and clinical chemistry parameters are reported.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Biological Test Results
Direct bilirubin
|
6 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Biological Test Results
White blood cell
|
9 Participants
|
10 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Hemoglobin
|
13 Participants
|
18 Participants
|
22 Participants
|
17 Participants
|
7 Participants
|
13 Participants
|
16 Participants
|
17 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Neutrophils
|
7 Participants
|
5 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Eosinophils
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Basophils
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Lymphocytes
|
4 Participants
|
13 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Monocytes
|
13 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
1 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Platelets
|
7 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Erythrocytes
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
5 Participants
|
6 Participants
|
20 Participants
|
15 Participants
|
16 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Creatinine
|
14 Participants
|
12 Participants
|
21 Participants
|
12 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
16 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Biological Test Results
C-reactive protein
|
22 Participants
|
24 Participants
|
15 Participants
|
24 Participants
|
4 Participants
|
17 Participants
|
23 Participants
|
23 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Aspartate aminotransferase
|
18 Participants
|
24 Participants
|
20 Participants
|
22 Participants
|
3 Participants
|
13 Participants
|
25 Participants
|
18 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Alanine aminotransferase
|
6 Participants
|
11 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Total bilirubin
|
6 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Biological Test Results
Troponin I
|
3 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: The mFAS included participants who had received the study vaccine.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% confidence interval (CI) was based on the Clopper-Pearson method.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 1
HAI homologous strain A/H1N1
|
86.2 titer
Interval 65.4 to 114.0
|
102 titer
Interval 76.4 to 136.0
|
86.2 titer
Interval 64.1 to 116.0
|
78.6 titer
Interval 59.8 to 103.0
|
98.2 titer
Interval 51.1 to 189.0
|
99.9 titer
Interval 72.7 to 137.0
|
102 titer
Interval 78.0 to 132.0
|
106 titer
Interval 79.7 to 140.0
|
80.9 titer
Interval 57.0 to 115.0
|
84.1 titer
Interval 46.0 to 154.0
|
|
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 1
HAI homologous strain A/H3N2
|
50.1 titer
Interval 36.7 to 68.5
|
53.3 titer
Interval 39.3 to 72.4
|
49.8 titer
Interval 37.3 to 66.5
|
45.0 titer
Interval 33.8 to 59.9
|
33.4 titer
Interval 16.5 to 67.8
|
60.1 titer
Interval 41.6 to 86.8
|
43.4 titer
Interval 32.1 to 58.7
|
55.4 titer
Interval 41.1 to 74.7
|
47.0 titer
Interval 32.8 to 67.3
|
50.0 titer
Interval 27.2 to 91.8
|
|
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 1
HAI homologous strain B/Yamagata-lineage
|
179 titer
Interval 142.0 to 225.0
|
278 titer
Interval 222.0 to 348.0
|
211 titer
Interval 169.0 to 264.0
|
192 titer
Interval 154.0 to 240.0
|
196 titer
Interval 125.0 to 310.0
|
245 titer
Interval 188.0 to 319.0
|
182 titer
Interval 140.0 to 236.0
|
209 titer
Interval 167.0 to 262.0
|
186 titer
Interval 137.0 to 252.0
|
244 titer
Interval 162.0 to 367.0
|
|
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 1
HAI homologous strain B/Victoria-lineage
|
86.7 titer
Interval 65.9 to 114.0
|
91.6 titer
Interval 69.3 to 121.0
|
94.6 titer
Interval 72.1 to 124.0
|
77.7 titer
Interval 59.3 to 102.0
|
65.1 titer
Interval 41.6 to 102.0
|
78.5 titer
Interval 57.0 to 108.0
|
76.4 titer
Interval 57.9 to 101.0
|
77.7 titer
Interval 58.9 to 103.0
|
139 titer
Interval 98.0 to 198.0
|
122 titer
Interval 74.5 to 199.0
|
PRIMARY outcome
Timeframe: Day 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Day 29 are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI was based on the Clopper-Pearson method.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H1N1
|
357 titer
Interval 283.0 to 451.0
|
447 titer
Interval 362.0 to 553.0
|
396 titer
Interval 317.0 to 495.0
|
558 titer
Interval 441.0 to 706.0
|
640 titer
Interval 348.0 to 1176.0
|
486 titer
Interval 385.0 to 613.0
|
314 titer
Interval 252.0 to 393.0
|
493 titer
Interval 395.0 to 615.0
|
221 titer
Interval 160.0 to 305.0
|
362 titer
Interval 235.0 to 558.0
|
|
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H3N2
|
320 titer
Interval 247.0 to 414.0
|
369 titer
Interval 286.0 to 477.0
|
445 titer
Interval 350.0 to 566.0
|
507 titer
Interval 396.0 to 649.0
|
503 titer
Interval 278.0 to 910.0
|
391 titer
Interval 281.0 to 542.0
|
232 titer
Interval 181.0 to 298.0
|
621 titer
Interval 476.0 to 811.0
|
216 titer
Interval 150.0 to 311.0
|
226 titer
Interval 126.0 to 407.0
|
|
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Yamagata-lineage
|
381 titer
Interval 310.0 to 468.0
|
603 titer
Interval 499.0 to 728.0
|
494 titer
Interval 409.0 to 596.0
|
585 titer
Interval 493.0 to 695.0
|
453 titer
Interval 306.0 to 668.0
|
524 titer
Interval 417.0 to 658.0
|
505 titer
Interval 405.0 to 629.0
|
651 titer
Interval 539.0 to 787.0
|
427 titer
Interval 325.0 to 562.0
|
390 titer
Interval 262.0 to 582.0
|
|
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Victoria-lineage
|
232 titer
Interval 183.0 to 295.0
|
242 titer
Interval 191.0 to 306.0
|
302 titer
Interval 241.0 to 379.0
|
269 titer
Interval 214.0 to 338.0
|
173 titer
Interval 95.7 to 314.0
|
270 titer
Interval 195.0 to 373.0
|
371 titer
Interval 302.0 to 455.0
|
320 titer
Interval 256.0 to 400.0
|
520 titer
Interval 391.0 to 692.0
|
256 titer
Interval 174.0 to 377.0
|
PRIMARY outcome
Timeframe: Day 1Population: The mFAS included participants who had received the study vaccine.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
HAI homologous strain A/H1N1
|
92.5 percentage of participants
Interval 86.2 to 96.5
|
90.7 percentage of participants
Interval 83.9 to 95.3
|
87.5 percentage of participants
Interval 80.2 to 92.8
|
91.5 percentage of participants
Interval 84.8 to 95.8
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
96.0 percentage of participants
Interval 88.8 to 99.2
|
94.1 percentage of participants
Interval 88.3 to 97.6
|
94.1 percentage of participants
Interval 88.3 to 97.6
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
HAI homologous strain A/H3N2
|
83.3 percentage of participants
Interval 75.4 to 89.5
|
85.6 percentage of participants
Interval 77.9 to 91.4
|
83.3 percentage of participants
Interval 75.4 to 89.5
|
84.6 percentage of participants
Interval 76.8 to 90.6
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
85.3 percentage of participants
Interval 75.3 to 92.4
|
79.8 percentage of participants
Interval 71.5 to 86.6
|
84.0 percentage of participants
Interval 76.2 to 90.1
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
HAI homologous strain B/Yamagata-lineage
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
98.3 percentage of participants
Interval 94.0 to 99.8
|
100 percentage of participants
Interval 97.0 to 100.0
|
98.3 percentage of participants
Interval 94.0 to 99.8
|
96.3 percentage of participants
Interval 81.0 to 99.9
|
100 percentage of participants
Interval 95.2 to 100.0
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
100 percentage of participants
Interval 96.9 to 100.0
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
HAI homologous strain B/Victoria-lineage
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
94.1 percentage of participants
Interval 88.2 to 97.6
|
95.0 percentage of participants
Interval 89.4 to 98.1
|
94.0 percentage of participants
Interval 88.1 to 97.6
|
100 percentage of participants
Interval 87.2 to 100.0
|
96.0 percentage of participants
Interval 88.8 to 99.2
|
93.3 percentage of participants
Interval 87.2 to 97.1
|
93.3 percentage of participants
Interval 87.2 to 97.1
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
PRIMARY outcome
Timeframe: Day 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Day 29 are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 29
HAI homologous strain A/H1N1
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 97.0 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
99.1 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 29
HAI homologous strain A/H3N2
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
98.3 percentage of participants
Interval 94.0 to 99.8
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 29
HAI homologous strain B/Yamagata-lineage
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 97.0 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 29
HAI homologous strain B/Victoria-lineage
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 97.0 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
98.6 percentage of participants
Interval 92.6 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
PRIMARY outcome
Timeframe: Days 1 and 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Days 1 and 29 are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Clopper-Pearson method.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H1N1
|
4.07 ratio
Interval 3.22 to 5.14
|
4.32 ratio
Interval 3.35 to 5.57
|
4.59 ratio
Interval 3.68 to 5.74
|
7.18 ratio
Interval 5.61 to 9.2
|
6.29 ratio
Interval 3.39 to 11.7
|
4.84 ratio
Interval 3.55 to 6.59
|
3.12 ratio
Interval 2.31 to 4.21
|
4.69 ratio
Interval 3.45 to 6.39
|
2.73 ratio
Interval 1.99 to 3.76
|
4.31 ratio
Interval 2.34 to 7.92
|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H3N2
|
6.34 ratio
Interval 5.03 to 7.98
|
6.85 ratio
Interval 5.26 to 8.92
|
8.93 ratio
Interval 6.92 to 11.5
|
11.4 ratio
Interval 8.6 to 15.1
|
14.0 ratio
Interval 7.18 to 27.3
|
6.68 ratio
Interval 5.19 to 8.6
|
5.44 ratio
Interval 4.09 to 7.25
|
11.0 ratio
Interval 8.21 to 14.8
|
4.59 ratio
Interval 3.25 to 6.5
|
4.53 ratio
Interval 2.34 to 8.75
|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Yamagata-lineage
|
2.12 ratio
Interval 1.83 to 2.46
|
2.15 ratio
Interval 1.81 to 2.54
|
2.34 ratio
Interval 1.99 to 2.74
|
3.08 ratio
Interval 2.53 to 3.74
|
2.29 ratio
Interval 1.45 to 3.6
|
2.14 ratio
Interval 1.77 to 2.58
|
2.82 ratio
Interval 2.19 to 3.63
|
3.08 ratio
Interval 2.52 to 3.77
|
2.30 ratio
Interval 1.71 to 3.09
|
1.60 ratio
Interval 1.06 to 2.41
|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Victoria-lineage
|
2.66 ratio
Interval 2.2 to 3.22
|
2.57 ratio
Interval 2.13 to 3.1
|
3.19 ratio
Interval 2.63 to 3.88
|
3.47 ratio
Interval 2.86 to 4.2
|
2.68 ratio
Interval 1.85 to 3.89
|
3.44 ratio
Interval 2.73 to 4.33
|
4.92 ratio
Interval 3.78 to 6.41
|
4.12 ratio
Interval 3.17 to 5.35
|
3.73 ratio
Interval 2.64 to 5.27
|
2.10 ratio
Interval 1.32 to 3.36
|
PRIMARY outcome
Timeframe: Day 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Day 29 are reported.
The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 29; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 29. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H1N1
|
51.3 percentage of participants
Interval 41.9 to 60.5
|
56.9 percentage of participants
Interval 47.4 to 66.1
|
63.3 percentage of participants
Interval 54.1 to 71.9
|
71.6 percentage of participants
Interval 62.4 to 79.5
|
65.4 percentage of participants
Interval 44.3 to 82.8
|
63.0 percentage of participants
Interval 50.9 to 74.0
|
35.9 percentage of participants
Interval 27.2 to 45.3
|
51.3 percentage of participants
Interval 41.9 to 60.6
|
38.3 percentage of participants
Interval 26.1 to 51.8
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H3N2
|
68.1 percentage of participants
Interval 58.9 to 76.3
|
69.8 percentage of participants
Interval 60.6 to 78.0
|
72.5 percentage of participants
Interval 63.6 to 80.3
|
80.2 percentage of participants
Interval 71.7 to 87.0
|
73.1 percentage of participants
Interval 52.2 to 88.4
|
75.3 percentage of participants
Interval 63.9 to 84.7
|
53.8 percentage of participants
Interval 44.4 to 63.1
|
73.5 percentage of participants
Interval 64.5 to 81.2
|
56.7 percentage of participants
Interval 43.2 to 69.4
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Yamagata-lineage
|
30.3 percentage of participants
Interval 22.2 to 39.3
|
31.9 percentage of participants
Interval 23.6 to 41.2
|
37.5 percentage of participants
Interval 28.8 to 46.8
|
44.0 percentage of participants
Interval 34.8 to 53.5
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
32.9 percentage of participants
Interval 22.3 to 44.9
|
37.6 percentage of participants
Interval 28.8 to 47.0
|
45.3 percentage of participants
Interval 36.1 to 54.8
|
31.7 percentage of participants
Interval 20.3 to 45.0
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Victoria-lineage
|
35.3 percentage of participants
Interval 26.8 to 44.6
|
37.1 percentage of participants
Interval 28.3 to 46.5
|
50.8 percentage of participants
Interval 41.6 to 60.1
|
50.0 percentage of participants
Interval 40.6 to 59.4
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
56.2 percentage of participants
Interval 44.1 to 67.8
|
58.1 percentage of participants
Interval 48.6 to 67.2
|
48.7 percentage of participants
Interval 39.4 to 58.1
|
50.0 percentage of participants
Interval 36.8 to 63.2
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
PRIMARY outcome
Timeframe: Day 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Day 29 are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 29
HAI homologous strain A/H1N1
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
98.3 percentage of participants
Interval 93.9 to 99.8
|
98.3 percentage of participants
Interval 94.1 to 99.8
|
97.4 percentage of participants
Interval 92.6 to 99.5
|
100 percentage of participants
Interval 86.8 to 100.0
|
98.6 percentage of participants
Interval 92.6 to 100.0
|
98.3 percentage of participants
Interval 94.0 to 99.8
|
96.6 percentage of participants
Interval 91.5 to 99.1
|
95.0 percentage of participants
Interval 86.1 to 99.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 29
HAI homologous strain A/H3N2
|
92.4 percentage of participants
Interval 86.1 to 96.5
|
96.6 percentage of participants
Interval 91.4 to 99.1
|
95.8 percentage of participants
Interval 90.5 to 98.6
|
98.3 percentage of participants
Interval 93.9 to 99.8
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
97.3 percentage of participants
Interval 90.5 to 99.7
|
94.0 percentage of participants
Interval 88.1 to 97.6
|
96.6 percentage of participants
Interval 91.5 to 99.1
|
91.7 percentage of participants
Interval 81.6 to 97.2
|
92.9 percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 29
HAI homologous strain B/Yamagata-lineage
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
99.1 percentage of participants
Interval 95.3 to 100.0
|
99.2 percentage of participants
Interval 95.4 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 86.8 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
99.1 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 96.9 to 100.0
|
100 percentage of participants
Interval 94.0 to 100.0
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 29
HAI homologous strain B/Victoria-lineage
|
92.4 percentage of participants
Interval 86.1 to 96.5
|
94.0 percentage of participants
Interval 88.0 to 97.5
|
96.7 percentage of participants
Interval 91.7 to 99.1
|
94.8 percentage of participants
Interval 89.1 to 98.1
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
93.2 percentage of participants
Interval 84.7 to 97.7
|
99.1 percentage of participants
Interval 95.3 to 100.0
|
94.9 percentage of participants
Interval 89.2 to 98.1
|
100 percentage of participants
Interval 94.0 to 100.0
|
100 percentage of participants
Interval 87.7 to 100.0
|
PRIMARY outcome
Timeframe: Days 1 and 29Population: The mFAS included participants who had received the study vaccine. During the study, participants miss few scheduled site visits for sample collection and only participants with data collected at Days 1 and 29 are reported.
The HAI Ab was measured by hemagglutinin inhibition using quality control sera (sheep, ferret and/or human sera) measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
QIV mRNA LNP 1: 96 mcg
n=119 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=116 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=26 Participants
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=73 Participants
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=117 Participants
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=117 Participants
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 Participants
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
QIV mRNA LNP 1: 30 mcg
n=28 Participants
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H1N1: 2-fold increase
|
79.0 percentage of participants
Interval 70.6 to 85.9
|
80.2 percentage of participants
Interval 71.7 to 87.0
|
85.8 percentage of participants
Interval 78.3 to 91.5
|
91.4 percentage of participants
Interval 84.7 to 95.8
|
80.8 percentage of participants
Interval 60.6 to 93.4
|
84.9 percentage of participants
Interval 74.6 to 92.2
|
65.8 percentage of participants
Interval 56.5 to 74.3
|
75.2 percentage of participants
Interval 66.4 to 82.7
|
65.0 percentage of participants
Interval 51.6 to 76.9
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H1N1: 4-fold increase
|
51.3 percentage of participants
Interval 41.9 to 60.5
|
56.9 percentage of participants
Interval 47.4 to 66.1
|
64.2 percentage of participants
Interval 54.9 to 72.7
|
72.4 percentage of participants
Interval 63.3 to 80.3
|
65.4 percentage of participants
Interval 44.3 to 82.8
|
63.0 percentage of participants
Interval 50.9 to 74.0
|
36.8 percentage of participants
Interval 28.0 to 46.2
|
51.3 percentage of participants
Interval 41.9 to 60.6
|
38.3 percentage of participants
Interval 26.1 to 51.8
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H3N2: 2-fold increase
|
89.9 percentage of participants
Interval 83.0 to 94.7
|
89.7 percentage of participants
Interval 82.6 to 94.5
|
93.3 percentage of participants
Interval 87.3 to 97.1
|
94.0 percentage of participants
Interval 88.0 to 97.5
|
92.3 percentage of participants
Interval 74.9 to 99.1
|
94.5 percentage of participants
Interval 86.6 to 98.5
|
77.8 percentage of participants
Interval 69.2 to 84.9
|
90.6 percentage of participants
Interval 83.8 to 95.2
|
83.3 percentage of participants
Interval 71.5 to 91.7
|
82.1 percentage of participants
Interval 63.1 to 93.9
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain A/H3N2: 4-fold increase
|
72.3 percentage of participants
Interval 63.3 to 80.1
|
71.6 percentage of participants
Interval 62.4 to 79.5
|
74.2 percentage of participants
Interval 65.4 to 81.7
|
80.2 percentage of participants
Interval 71.7 to 87.0
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
76.7 percentage of participants
Interval 65.4 to 85.8
|
56.4 percentage of participants
Interval 46.9 to 65.6
|
74.4 percentage of participants
Interval 65.5 to 82.0
|
56.7 percentage of participants
Interval 43.2 to 69.4
|
67.9 percentage of participants
Interval 47.6 to 84.1
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Yamagata-lineage: 2-fold increase
|
66.4 percentage of participants
Interval 57.2 to 74.8
|
64.7 percentage of participants
Interval 55.2 to 73.3
|
73.3 percentage of participants
Interval 64.5 to 81.0
|
78.4 percentage of participants
Interval 69.9 to 85.5
|
76.9 percentage of participants
Interval 56.4 to 91.0
|
68.5 percentage of participants
Interval 56.6 to 78.9
|
61.5 percentage of participants
Interval 52.1 to 70.4
|
75.2 percentage of participants
Interval 66.4 to 82.7
|
70.0 percentage of participants
Interval 56.8 to 81.2
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Yamagata-lineage: 4-fold increase
|
30.3 percentage of participants
Interval 22.2 to 39.3
|
31.9 percentage of participants
Interval 23.6 to 41.2
|
37.5 percentage of participants
Interval 28.8 to 46.8
|
44.0 percentage of participants
Interval 34.8 to 53.5
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
32.9 percentage of participants
Interval 22.3 to 44.9
|
37.6 percentage of participants
Interval 28.8 to 47.0
|
45.3 percentage of participants
Interval 36.1 to 54.8
|
31.7 percentage of participants
Interval 20.3 to 45.0
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Victoria-lineage: 2-fold increase
|
70.6 percentage of participants
Interval 61.5 to 78.6
|
73.3 percentage of participants
Interval 64.3 to 81.1
|
77.5 percentage of participants
Interval 69.0 to 84.6
|
83.6 percentage of participants
Interval 75.6 to 89.8
|
88.5 percentage of participants
Interval 69.8 to 97.6
|
76.7 percentage of participants
Interval 65.4 to 85.8
|
77.8 percentage of participants
Interval 69.2 to 84.9
|
71.8 percentage of participants
Interval 62.7 to 79.7
|
71.7 percentage of participants
Interval 58.6 to 82.5
|
60.7 percentage of participants
Interval 40.6 to 78.5
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Hemagglutination Inhibition Antibody Titer at Day 29
HAI homologous strain B/Victoria-lineage: 4-fold increase
|
37.0 percentage of participants
Interval 28.3 to 46.3
|
37.1 percentage of participants
Interval 28.3 to 46.5
|
52.5 percentage of participants
Interval 43.2 to 61.7
|
51.7 percentage of participants
Interval 42.3 to 61.1
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
56.2 percentage of participants
Interval 44.1 to 67.8
|
59.0 percentage of participants
Interval 49.5 to 68.0
|
50.4 percentage of participants
Interval 41.0 to 59.8
|
50.0 percentage of participants
Interval 36.8 to 63.2
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
SECONDARY outcome
Timeframe: Days 1 and 29Population: As stated in the Clinical Study Report, samples for the assessment of neutralizing antibodies were not collected from study participants. Consequently, no neutralizing antibody analyses were conducted. Furthermore, as the study has been completed, the sponsor does not intend to collect samples or perform neutralizing antibody analyses in the future.
The NT Ab was planned to be measured using seroneutralization (SN) measurement method. The 95% CI was planned to be calculated using the Clopper-Pearson method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 29Population: As stated in the Clinical Study Report, samples for the assessment of neutralizing antibodies were not collected from study participants. Consequently, no neutralizing antibody analyses were conducted. Furthermore, as the study has been completed, the sponsor does not intend to collect samples or perform neutralizing antibody analyses in the future.
The NT Ab was planned to be measured using SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination was planned to be reported. The 95% CI was planned to be calculated using the Clopper-Pearson method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1 and 29Population: As stated in the Clinical Study Report, samples for the assessment of neutralizing antibodies were not collected from study participants. Consequently, no neutralizing antibody analyses were conducted. Furthermore, as the study has been completed, the sponsor does not intend to collect samples or perform neutralizing antibody analyses in the future.
The NT Ab was planned to be measured using SN measurement method. The 95% CI for the single percentage was planned to be calculated using the Clopper-Pearson method.
Outcome measures
Outcome data not reported
Adverse Events
QIV mRNA LNP 1: 30 mcg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
QIV mRNA LNP 1: 96 mcg
Serious events: 4 serious events
Other events: 81 other events
Deaths: 1 deaths
QIV mRNA LNP 1: 132 mcg
Serious events: 2 serious events
Other events: 87 other events
Deaths: 0 deaths
QIV mRNA LNP 1: 192 mcg
Serious events: 3 serious events
Other events: 91 other events
Deaths: 0 deaths
QIV mRNA LNP 2: 96 mcg
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
QIV mRNA LNP 2: 192 mcg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
QIV mRNA LNP 3: 192 mcg
Serious events: 1 serious events
Other events: 57 other events
Deaths: 0 deaths
QIV-SD
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
RIV4
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
QIV-HD
Serious events: 1 serious events
Other events: 24 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
QIV mRNA LNP 1: 30 mcg
n=28 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
QIV mRNA LNP 1: 96 mcg
n=120 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 participants at risk
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 participants at risk
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 participants at risk
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
1.3%
1/75 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Gastrointestinal disorders
Duodenal Ulcer Perforation
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.85%
1/118 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Chest Pain
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Death
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
1.7%
1/60 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.85%
1/118 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Injury, poisoning and procedural complications
Sternal Fracture
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.83%
1/120 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/118 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/120 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/117 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/75 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
Other adverse events
| Measure |
QIV mRNA LNP 1: 30 mcg
n=28 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 30 microgram (mcg) intramuscular (IM) injection on Day 1.
|
QIV mRNA LNP 1: 96 mcg
n=120 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 132 mcg
n=118 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 132 mcg IM injection on Day 1.
|
QIV mRNA LNP 1: 192 mcg
n=120 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 1: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 96 mcg
n=117 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 2: 96 mcg IM injection on Day 1.
|
QIV mRNA LNP 2: 192 mcg
n=27 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 2: 192 mcg IM injection on Day 1.
|
QIV mRNA LNP 3: 192 mcg
n=75 participants at risk
Participants received a single vaccine dose of QIV mRNA LNP 3: 192 mcg IM injection on Day 1.
|
QIV-SD
n=119 participants at risk
Participants received a single vaccine dose of QIV-SD IM injection on Day 1.
|
RIV4
n=119 participants at risk
Participants received a single vaccine dose of RIV4 IM injection on Day 1.
|
QIV-HD
n=60 participants at risk
Participants received a single vaccine dose of QIV-HD IM injection on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
39.3%
11/28 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
35.8%
43/120 • Number of events 43 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
44.1%
52/118 • Number of events 52 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
49.2%
59/120 • Number of events 59 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
35.9%
42/117 • Number of events 42 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
55.6%
15/27 • Number of events 15 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
46.7%
35/75 • Number of events 35 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
10.9%
13/119 • Number of events 13 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
8.4%
10/119 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
20.0%
12/60 • Number of events 12 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Injection Site Erythema
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
6.7%
8/120 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
8.5%
10/118 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
13.3%
16/120 • Number of events 16 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
9.4%
11/117 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
25.9%
7/27 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
13.3%
10/75 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
2.5%
3/119 • Number of events 3 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
5.0%
3/60 • Number of events 3 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Injection Site Pain
|
39.3%
11/28 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
57.5%
69/120 • Number of events 69 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
64.4%
76/118 • Number of events 76 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
65.8%
79/120 • Number of events 79 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
63.2%
74/117 • Number of events 74 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
63.0%
17/27 • Number of events 17 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
65.3%
49/75 • Number of events 49 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
19.3%
23/119 • Number of events 23 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
15.1%
18/119 • Number of events 18 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
20.0%
12/60 • Number of events 12 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Injection Site Swelling
|
3.6%
1/28 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
7.5%
9/120 • Number of events 9 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
11.9%
14/118 • Number of events 14 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
8.3%
10/120 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
13.7%
16/117 • Number of events 16 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
25.9%
7/27 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
10.7%
8/75 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/119 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
1.7%
2/119 • Number of events 2 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
5.0%
3/60 • Number of events 3 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Pyrexia
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
8.3%
10/120 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
6.8%
8/118 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
15.0%
18/120 • Number of events 18 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
4.3%
5/117 • Number of events 5 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
22.2%
6/27 • Number of events 6 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
9.3%
7/75 • Number of events 7 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Nervous system disorders
Headache
|
35.7%
10/28 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
30.8%
37/120 • Number of events 37 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
33.9%
40/118 • Number of events 41 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
40.8%
49/120 • Number of events 50 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
34.2%
40/117 • Number of events 41 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
44.4%
12/27 • Number of events 12 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
41.3%
31/75 • Number of events 32 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
9.2%
11/119 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
5.0%
6/119 • Number of events 6 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
10.0%
6/60 • Number of events 7 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
7/28 • Number of events 7 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
24.2%
29/120 • Number of events 29 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
22.9%
27/118 • Number of events 27 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
24.2%
29/120 • Number of events 29 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
20.5%
24/117 • Number of events 24 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
29.6%
8/27 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
21.3%
16/75 • Number of events 16 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
3.4%
4/119 • Number of events 4 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
4.2%
5/119 • Number of events 6 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
6.7%
4/60 • Number of events 5 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
39.3%
11/28 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
38.3%
46/120 • Number of events 46 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
46.6%
55/118 • Number of events 55 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
50.0%
60/120 • Number of events 61 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
41.9%
49/117 • Number of events 50 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
51.9%
14/27 • Number of events 14 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
45.3%
34/75 • Number of events 34 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
8.4%
10/119 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
6.7%
8/119 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
15.0%
9/60 • Number of events 9 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
General disorders
Chills
|
21.4%
6/28 • Number of events 6 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
20.8%
25/120 • Number of events 25 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
23.7%
28/118 • Number of events 28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
23.3%
28/120 • Number of events 28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
26.5%
31/117 • Number of events 31 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
40.7%
11/27 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
30.7%
23/75 • Number of events 23 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
2.5%
3/119 • Number of events 3 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
3.4%
4/119 • Number of events 4 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
3.3%
2/60 • Number of events 2 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
|
Investigations
C-Reactive Protein Increased
|
0.00%
0/28 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
9.2%
11/120 • Number of events 11 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
6.8%
8/118 • Number of events 8 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
11.7%
14/120 • Number of events 14 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
12.8%
15/117 • Number of events 15 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
22.2%
6/27 • Number of events 6 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
13.3%
10/75 • Number of events 10 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.84%
1/119 • Number of events 1 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
0.00%
0/60 • SAEs, other AEs and all-cause mortality were collected from the vaccine administration (Day 1) until 12 months after vaccine administration, approximately 366 days.
Analysis was performed on the mFAS.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER