Trial Outcomes & Findings for Study Describing the Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) Versus a Licensed Quadrivalent-inactivated Influenza Vaccine (IIV4) (Fluarix® Quadrivalent) in Participants 18 Years of Age and Older in South Korea (NCT NCT05144945)
NCT ID: NCT05144945
Last Updated: 2025-09-11
Results Overview
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
301 participants
Primary outcome timeframe
Day 1 (pre-vaccination)
Results posted on
2025-09-11
Participant Flow
The study was conducted at 3 active sites in South Korea from 07 December 2021 to 01 September 2022.
A total of 301 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
Participants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
151
|
|
Overall Study
Safety Analysis Set
|
149
|
151
|
|
Overall Study
COMPLETED
|
149
|
151
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
Participants received a single intramuscular (IM) injection of 0.5 milliliters (mL) RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.2 years
STANDARD_DEVIATION 11.9 • n=150 Participants
|
46.1 years
STANDARD_DEVIATION 12.6 • n=151 Participants
|
46.1 years
STANDARD_DEVIATION 12.2 • n=301 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=150 Participants
|
89 Participants
n=151 Participants
|
184 Participants
n=301 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=150 Participants
|
62 Participants
n=151 Participants
|
117 Participants
n=301 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination)Population: Analysis was performed on PPAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants with protocol deviations were excluded from the PPAS.
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)
A/H1N1
|
30.8 titers
Interval 24.7 to 38.3
|
38.9 titers
Interval 31.7 to 47.7
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)
A/H3N2
|
50.1 titers
Interval 40.7 to 61.7
|
47.5 titers
Interval 39.1 to 57.6
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)
B/Victoria
|
109 titers
Interval 86.6 to 136.0
|
104 titers
Interval 83.2 to 130.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Per Protocol Analysis Set (PPAS)
B/Yamagata
|
237 titers
Interval 185.0 to 302.0
|
262 titers
Interval 213.0 to 323.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination)Population: Analysis was performed on FAS population that included all randomized participants who received a dose of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the intervention to which they were randomized.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)
A/H1N1
|
29.8 titers
Interval 24.0 to 37.1
|
38.7 titers
Interval 31.6 to 47.4
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)
A/H3N2
|
49.3 titers
Interval 40.1 to 60.6
|
47.2 titers
Interval 38.9 to 57.2
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)
B/Victoria
|
104 titers
Interval 83.2 to 131.0
|
103 titers
Interval 81.8 to 128.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 1- Full Analysis Set (FAS)
B/Yamagata
|
239 titers
Interval 188.0 to 304.0
|
259 titers
Interval 210.0 to 319.0
|
PRIMARY outcome
Timeframe: Day 29 (post-vaccination)Population: Analysis was performed on PPAS population.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS
A/H1N1
|
961 titers
Interval 784.0 to 1177.0
|
868 titers
Interval 732.0 to 1030.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS
A/H3N2
|
643 titers
Interval 529.0 to 781.0
|
378 titers
Interval 321.0 to 445.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS
B/Victoria
|
646 titers
Interval 523.0 to 798.0
|
490 titers
Interval 413.0 to 580.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- PPAS
B/Yamagata
|
1268 titers
Interval 1072.0 to 1499.0
|
897 titers
Interval 782.0 to 1029.0
|
PRIMARY outcome
Timeframe: Day 29 (post-vaccination)Population: Analysis was performed on FAS population.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS
A/H1N1
|
955 titers
Interval 783.0 to 1164.0
|
863 titers
Interval 728.0 to 1022.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS
A/H3N2
|
649 titers
Interval 535.0 to 787.0
|
379 titers
Interval 323.0 to 446.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS
B/Victoria
|
640 titers
Interval 520.0 to 788.0
|
486 titers
Interval 410.0 to 576.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 29- FAS
B/Yamagata
|
1268 titers
Interval 1076.0 to 1495.0
|
899 titers
Interval 784.0 to 1031.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on PPAS population.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS
A/H1N1
|
31.2 ratio
Interval 25.2 to 38.8
|
22.3 ratio
Interval 17.9 to 27.8
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS
A/H3N2
|
12.8 ratio
Interval 10.2 to 16.1
|
7.96 ratio
Interval 6.43 to 9.87
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS
B/Victoria
|
5.95 ratio
Interval 4.82 to 7.34
|
4.70 ratio
Interval 3.82 to 5.79
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-PPAS
B/Yamagata
|
5.35 ratio
Interval 4.36 to 6.58
|
3.42 ratio
Interval 2.85 to 4.1
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on FAS population.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. GMFR were calculated as the ratio of GMTs post-vaccination (on Day 29) and pre-vaccination (on Day 1).
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS
A/H1N1
|
32.0 ratio
Interval 25.8 to 39.6
|
22.3 ratio
Interval 17.9 to 27.7
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS
A/H3N2
|
13.2 ratio
Interval 10.5 to 16.4
|
8.04 ratio
Interval 6.49 to 9.95
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS
B/Victoria
|
6.14 ratio
Interval 4.99 to 7.55
|
4.74 ratio
Interval 3.86 to 5.83
|
|
Geometric Mean Fold-rise (GMFR) for Influenza Vaccine Antibodies-FAS
B/Yamagata
|
5.31 ratio
Interval 4.33 to 6.51
|
3.47 ratio
Interval 2.89 to 4.17
|
PRIMARY outcome
Timeframe: Day 29 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS
A/H1N1
|
95.9 percentage of participants
Interval 91.2 to 98.5
|
92.0 percentage of participants
Interval 86.4 to 95.8
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS
A/H3N2
|
90.3 percentage of participants
Interval 84.3 to 94.6
|
74.7 percentage of participants
Interval 66.9 to 81.4
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS
B/Victoria
|
73.1 percentage of participants
Interval 65.1 to 80.1
|
56.0 percentage of participants
Interval 47.7 to 64.1
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-PPAS
B/Yamagata
|
69.0 percentage of participants
Interval 60.8 to 76.4
|
47.3 percentage of participants
Interval 39.1 to 55.6
|
PRIMARY outcome
Timeframe: Day 29 (post-vaccination)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (\<) 1:10 (1/dilution) and a post-vaccination titer \>=1:40 (1/dilution) or a pre-vaccination titer \>= 1:10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 29.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS
A/H1N1
|
96.0 percentage of participants
Interval 91.4 to 98.5
|
92.1 percentage of participants
Interval 86.5 to 95.8
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS
A/H3N2
|
90.6 percentage of participants
Interval 84.7 to 94.8
|
74.8 percentage of participants
Interval 67.1 to 81.5
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS
B/Victoria
|
73.8 percentage of participants
Interval 66.0 to 80.7
|
56.3 percentage of participants
Interval 48.0 to 64.3
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Vaccine Antibodies-FAS
B/Yamagata
|
67.8 percentage of participants
Interval 59.6 to 75.2
|
47.7 percentage of participants
Interval 39.5 to 56.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
A/H1N1: Day 1
|
51.7 percentage of participants
Interval 43.3 to 60.1
|
58.0 percentage of participants
Interval 49.7 to 66.0
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
A/H3N2: Day 1
|
69.7 percentage of participants
Interval 61.5 to 77.0
|
65.3 percentage of participants
Interval 57.1 to 72.9
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
B/Victoria: Day 1
|
82.8 percentage of participants
Interval 75.6 to 88.5
|
82.7 percentage of participants
Interval 75.6 to 88.4
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
B/Yamagata: Day 1
|
89.7 percentage of participants
Interval 83.5 to 94.1
|
94.7 percentage of participants
Interval 89.8 to 97.7
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
A/H1N1: Day 29
|
98.6 percentage of participants
Interval 95.1 to 99.8
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
A/H3N2: Day 29
|
99.3 percentage of participants
Interval 96.2 to 100.0
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
B/Victoria: Day 29
|
99.3 percentage of participants
Interval 96.2 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 40 (1/Dilution) Against Influenza Vaccine Antibodies-PPAS
B/Yamagata: Day 29
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=40 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
A/H1N1: Day 1
|
51.0 percentage of participants
Interval 42.7 to 59.3
|
57.6 percentage of participants
Interval 49.3 to 65.6
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
A/H3N2: Day 1
|
69.1 percentage of participants
Interval 61.0 to 76.4
|
64.9 percentage of participants
Interval 56.7 to 72.5
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
B/Victoria: Day 1
|
81.9 percentage of participants
Interval 74.7 to 87.7
|
82.1 percentage of participants
Interval 75.1 to 87.9
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
B/Yamagata: Day 1
|
89.9 percentage of participants
Interval 83.9 to 94.3
|
94.7 percentage of participants
Interval 89.8 to 97.7
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
A/H1N1: Day 29
|
98.7 percentage of participants
Interval 95.2 to 99.8
|
99.3 percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
A/H3N2: Day 29
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
99.3 percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
B/Victoria: Day 29
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) Against Influenza Vaccine Antibodies-FAS
B/Yamagata: Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on PPAS population. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=145 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=150 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
A/H1N1: Day 1
|
82.1 percentage of participants
Interval 74.8 to 87.9
|
90.0 percentage of participants
Interval 84.0 to 94.3
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
A/H3N2: Day 1
|
91.0 percentage of participants
Interval 85.2 to 95.1
|
93.3 percentage of participants
Interval 88.1 to 96.8
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
B/Victoria: Day 1
|
96.6 percentage of participants
Interval 92.1 to 98.9
|
96.0 percentage of participants
Interval 91.5 to 98.5
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
B/Yamagata: Day 1
|
96.6 percentage of participants
Interval 92.1 to 98.9
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
A/H1N1: Day 29
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
A/H3N2: Day 29
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
B/Victoria: Day 29
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- PPAS
B/Yamagata: Day 29
|
100 percentage of participants
Interval 97.5 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 29 (post-vaccination)Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers \>=10 (1/dilution) against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
A/H1N1: Day 1
|
81.2 percentage of participants
Interval 74.0 to 87.1
|
90.1 percentage of participants
Interval 84.1 to 94.3
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
A/H3N2: Day 1
|
90.6 percentage of participants
Interval 84.7 to 94.8
|
93.4 percentage of participants
Interval 88.2 to 96.8
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
B/Victoria: Day 1
|
96.0 percentage of participants
Interval 91.4 to 98.5
|
96.0 percentage of participants
Interval 91.6 to 98.5
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
B/Yamagata: Day 1
|
96.6 percentage of participants
Interval 92.3 to 98.9
|
99.3 percentage of participants
Interval 96.4 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
A/H1N1: Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
A/H3N2: Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
B/Victoria: Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
|
Percentage of Participants With Detectable Antibody Titers >= 10 (1/Dilution) Against Influenza Vaccine Antibodies- FAS
B/Yamagata: Day 29
|
100 percentage of participants
Interval 97.6 to 100.0
|
100 percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: Within 30 minutes post-vaccinationPopulation: Analysis was performed on safety analysis set that included participants who had received a dose of the study vaccine and were analyzed according to the vaccine they actually received.
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccinationPopulation: Analysis was performed on safety analysis set.
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited systemic reactions included fever, headache, malaise, myalgia, shivering, fatigue, nausea, and arthralgia.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Solicited Systemic Reactions
Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Headache
|
21 Participants
|
38 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Malaise
|
50 Participants
|
49 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Myalgia
|
64 Participants
|
64 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Shivering
|
14 Participants
|
16 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Fatigue
|
35 Participants
|
40 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Nausea
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Solicited Systemic Reactions
Arthralgia
|
12 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccinationPopulation: Analysis was performed on safety analysis set.
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRF and considered as related to the study intervention administered. Solicited injection site reactions included pain, erythema, swelling, induration, bruising and tenderness.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site Reactions
Pain
|
77 Participants
|
83 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Erythema
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Swelling
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Induration
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Bruising
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site Reactions
Tenderness
|
34 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 28 days post-vaccination (i.e., up to Day 29)Population: Analysis was performed on safety analysis set.
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not had any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
|
16 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 6 months post-vaccination (i.e., up to Day 181)Population: Analysis was performed on safety analysis set.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. A SAE which caused death of the participant was considered as fatal SAE. An AESIs were defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Outcome measures
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 Participants
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 Participants
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI)
AESI
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
Serious events: 0 serious events
Other events: 96 other events
Deaths: 0 deaths
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
Serious events: 0 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4)
n=149 participants at risk
Participants received a single IM injection of 0.5 mL RIV4 on Day 1.
|
Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4)
n=151 participants at risk
Participants received a single IM injection of 0.5 mL IIV4 on Day 1.
|
|---|---|---|
|
General disorders
Chills
|
9.4%
14/149 • Number of events 14 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
10.6%
16/151 • Number of events 16 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
General disorders
Fatigue
|
23.5%
35/149 • Number of events 35 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
26.5%
40/151 • Number of events 40 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
General disorders
Injection Site Pain
|
55.0%
82/149 • Number of events 111 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
56.3%
85/151 • Number of events 104 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
General disorders
Malaise
|
33.6%
50/149 • Number of events 50 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
32.5%
49/151 • Number of events 49 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
12/149 • Number of events 12 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
10.6%
16/151 • Number of events 16 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
43.0%
64/149 • Number of events 64 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
42.4%
64/151 • Number of events 64 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
|
Nervous system disorders
Headache
|
15.4%
23/149 • Number of events 23 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
25.2%
38/151 • Number of events 38 • Unsolicited AE data were collected from Day 1 up to 28 days post-vaccination. Solicited reaction data were collected within 7 days post-vaccination. SAEs data were collected from Day 1 up to 6 months post-vaccination (i.e., up to Day 181)
Analysis was performed on safety analysis set. Solicited reaction was an expected adverse reaction (sign or symptoms) observed and reported under conditions prelisted (i.e., solicited) in CRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRF in terms of symptom and/or onset window post-vaccination. In AE section, solicited reaction Shivering was reported as Chills.
|
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 participant 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