Trial Outcomes & Findings for Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older (NCT NCT04498832)
NCT ID: NCT04498832
Last Updated: 2025-09-23
Results Overview
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2100 participants
Primary outcome timeframe
Day 28 (post-vaccination)
Results posted on
2025-09-23
Participant Flow
The study was conducted at 10 active centers in Japan.
A total of 2100 participants were enrolled and randomized between 21 October 2020 to 14 January 2021.
Participant milestones
| Measure |
QIV-HD
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
QIV-SD
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
1049
|
1051
|
|
Overall Study
COMPLETED
|
1048
|
1047
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
QIV-HD
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
QIV-SD
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older
Baseline characteristics by cohort
| Measure |
QIV-HD
n=1049 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
QIV-SD
n=1051 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
Total Title
n=2100 Participants
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 4.89 • n=93 Participants
|
68.4 years
STANDARD_DEVIATION 4.96 • n=4 Participants
|
68.3 years
STANDARD_DEVIATION 4.93 • n=27 Participants
|
|
Sex: Female, Male
Female
|
486 Participants
n=93 Participants
|
504 Participants
n=4 Participants
|
990 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
563 Participants
n=93 Participants
|
547 Participants
n=4 Participants
|
1110 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1049 Participants
n=93 Participants
|
1051 Participants
n=4 Participants
|
2100 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 28 (post-vaccination)Population: Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
A/H1N1
|
110.0 titers
Interval 100.0 to 121.1
|
309.0 titers
Interval 282.1 to 338.4
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
A/H3N2-like
|
239.9 titers
Interval 222.0 to 259.1
|
540.0 titers
Interval 504.4 to 578.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
B/Victoria-like
|
139.2 titers
Interval 129.4 to 149.8
|
354.8 titers
Interval 333.0 to 378.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
B/Yamagata
|
254.7 titers
Interval 237.7 to 273.0
|
795.8 titers
Interval 750.3 to 844.1
|
PRIMARY outcome
Timeframe: Day 28 (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 by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
A/H1N1
|
47.9 percentage of participants
Interval 44.9 to 51.0
|
77.6 percentage of participants
Interval 75.0 to 80.1
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
A/H3N2-like
|
47.3 percentage of participants
Interval 44.2 to 50.4
|
75.4 percentage of participants
Interval 72.6 to 77.9
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
B/Victoria-like
|
47.8 percentage of participants
Interval 44.7 to 50.8
|
79.2 percentage of participants
Interval 76.6 to 81.6
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
B/Yamagata
|
39.0 percentage of participants
Interval 36.1 to 42.1
|
74.4 percentage of participants
Interval 71.7 to 77.1
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 (post-vaccination)Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Victoria: Day 28
|
152.0 titers
Interval 141.4 to 163.4
|
447.3 titers
Interval 420.8 to 475.5
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H1N1: Day 0
|
14.9 titers
Interval 13.9 to 16.1
|
14.5 titers
Interval 13.5 to 15.5
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H1N1: Day 28
|
110.0 titers
Interval 100.0 to 121.1
|
309.0 titers
Interval 282.1 to 338.4
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H3N2: Day 0
|
54.6 titers
Interval 50.0 to 59.7
|
54.9 titers
Interval 50.3 to 59.9
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H3N2: Day 28
|
319.9 titers
Interval 297.1 to 344.5
|
721.4 titers
Interval 676.6 to 769.2
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H3N2-like: Day 0
|
41.0 titers
Interval 37.6 to 44.7
|
40.8 titers
Interval 37.5 to 44.4
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
A/H3N2-like: Day 28
|
239.9 titers
Interval 222.0 to 259.1
|
540.0 titers
Interval 504.4 to 578.0
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Victoria: Day 0
|
24.7 titers
Interval 23.0 to 26.5
|
26.3 titers
Interval 24.4 to 28.3
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Victoria-like: Day 0
|
22.3 titers
Interval 20.9 to 23.9
|
23.7 titers
Interval 22.1 to 25.5
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Victoria-like: Day 28
|
139.2 titers
Interval 129.4 to 149.8
|
354.8 titers
Interval 333.0 to 378.0
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Yamagata: Day 0
|
60.4 titers
Interval 55.3 to 66.0
|
70.4 titers
Interval 64.4 to 77.1
|
|
GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
B/Yamagata: Day 28
|
254.7 titers
Interval 237.7 to 273.0
|
795.8 titers
Interval 750.3 to 844.1
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 28 (post-vaccination)Population: Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.
GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
A/H1N1
|
7.33 ratio
Interval 6.71 to 8.01
|
21.33 ratio
Interval 19.57 to 23.25
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
A/H3N2
|
5.86 ratio
Interval 5.34 to 6.42
|
13.14 ratio
Interval 12.05 to 14.32
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
A/H3N2-like
|
5.85 ratio
Interval 5.33 to 6.42
|
13.23 ratio
Interval 12.13 to 14.43
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
B/Victoria
|
6.17 ratio
Interval 5.66 to 6.72
|
17.06 ratio
Interval 15.78 to 18.44
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
B/Victoria-like
|
6.27 ratio
Interval 5.76 to 6.82
|
14.97 ratio
Interval 13.88 to 16.14
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
B/Yamagata
|
4.21 ratio
Interval 3.88 to 4.57
|
11.29 ratio
Interval 10.39 to 12.27
|
SECONDARY outcome
Timeframe: Day 28 (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 by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer \<10 (1/dilution) and a post-vaccination titer \>=40 (1/dilution) or a pre-vaccination titer \>=10 (1/dilution) and a \>= four-fold increase in post-vaccination titer at Day 28.
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
A/H1N1
|
47.9 percentage of participants
Interval 44.9 to 51.0
|
77.6 percentage of participants
Interval 75.0 to 80.1
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
A/H3N2
|
48.2 percentage of participants
Interval 45.2 to 51.3
|
76.4 percentage of participants
Interval 73.7 to 79.0
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
A/H3N2-like
|
47.3 percentage of participants
Interval 44.2 to 50.4
|
75.4 percentage of participants
Interval 72.6 to 77.9
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
B/Victoria
|
47.4 percentage of participants
Interval 44.3 to 50.4
|
82.1 percentage of participants
Interval 79.7 to 84.4
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
B/Victoria-like
|
47.8 percentage of participants
Interval 44.7 to 50.8
|
79.2 percentage of participants
Interval 76.6 to 81.6
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
B/Yamagata
|
39.0 percentage of participants
Interval 36.1 to 42.1
|
74.4 percentage of participants
Interval 71.7 to 77.1
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 28 (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 method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers \>=40 (1/dilution) is reported in the outcome measure.
Outcome measures
| Measure |
QIV-SD
n=1047 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1048 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H1N1: Day 0
|
18.2 percentage of participants
Interval 15.9 to 20.7
|
16.1 percentage of participants
Interval 13.9 to 18.4
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H1N1: Day 28
|
67.6 percentage of participants
Interval 64.7 to 70.5
|
85.1 percentage of participants
Interval 82.8 to 87.2
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H3N2: Day 0
|
51.7 percentage of participants
Interval 48.6 to 54.7
|
52.3 percentage of participants
Interval 49.3 to 55.4
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H3N2: Day 28
|
93.4 percentage of participants
Interval 91.7 to 94.8
|
98.9 percentage of participants
Interval 98.0 to 99.4
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H3N2-like: Day 0
|
43.7 percentage of participants
Interval 40.7 to 46.8
|
43.9 percentage of participants
Interval 40.9 to 47.0
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
A/H3N2-like: Day 28
|
88.4 percentage of participants
Interval 86.3 to 90.3
|
96.8 percentage of participants
Interval 95.5 to 97.7
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Victoria: Day 0
|
27.8 percentage of participants
Interval 25.1 to 30.7
|
29.7 percentage of participants
Interval 27.0 to 32.6
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Victoria: Day 28
|
81.4 percentage of participants
Interval 78.9 to 83.7
|
97.9 percentage of participants
Interval 96.8 to 98.7
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Victoria-like: Day 0
|
24.1 percentage of participants
Interval 21.5 to 26.8
|
25.1 percentage of participants
Interval 22.5 to 27.9
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Victoria-like: Day 28
|
79.8 percentage of participants
Interval 77.2 to 82.1
|
96.8 percentage of participants
Interval 95.5 to 97.7
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Yamagata: Day 0
|
56.9 percentage of participants
Interval 53.9 to 60.0
|
60.6 percentage of participants
Interval 57.5 to 63.6
|
|
Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
B/Yamagata: Day 28
|
92.3 percentage of participants
Interval 90.5 to 93.8
|
98.9 percentage of participants
Interval 98.0 to 99.4
|
SECONDARY outcome
Timeframe: Within 30 minutes post-vaccinationPopulation: Analysis was performed on safety analysis set (SafAS) population which included participants who had received the study vaccine and had any safety data available.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Outcome measures
| Measure |
QIV-SD
n=1051 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1049 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days post-vaccinationPopulation: Analysis was performed on the SafAS population.
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 CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Outcome measures
| Measure |
QIV-SD
n=1051 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1049 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site pain
|
334 Participants
|
503 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site erythema
|
328 Participants
|
86 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site swelling
|
185 Participants
|
82 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site induration
|
107 Participants
|
52 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site bruising
|
11 Participants
|
5 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Fever
|
1 Participants
|
8 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Headache
|
75 Participants
|
105 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Malaise
|
59 Participants
|
102 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Myalgia
|
130 Participants
|
197 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions
Shivering
|
25 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Within 28 days post-vaccinationPopulation: Analysis was performed on SafAS population.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
QIV-SD
n=1051 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1049 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
|
85 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 28 post-vaccinationPopulation: Analysis was performed on the SafAS population.
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.
Outcome measures
| Measure |
QIV-SD
n=1051 Participants
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
QIV-HD
n=1049 Participants
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
5 Participants
|
2 Participants
|
Adverse Events
QIV-HD
Serious events: 2 serious events
Other events: 614 other events
Deaths: 0 deaths
QIV-SD
Serious events: 5 serious events
Other events: 569 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QIV-HD
n=1049 participants at risk
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
QIV-SD
n=1051 participants at risk
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1049 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.10%
1/1051 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/1049 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.10%
1/1051 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.10%
1/1049 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.00%
0/1051 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/1049 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.10%
1/1051 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/1049 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.10%
1/1051 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.10%
1/1049 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.00%
0/1051 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Still's Disease
|
0.00%
0/1049 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
0.10%
1/1051 • Number of events 1 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
Other adverse events
| Measure |
QIV-HD
n=1049 participants at risk
Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
|
QIV-SD
n=1051 participants at risk
Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
8.2%
86/1049 • Number of events 86 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
31.2%
328/1051 • Number of events 328 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
General disorders
Injection Site Induration
|
5.0%
52/1049 • Number of events 52 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
10.2%
107/1051 • Number of events 107 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
General disorders
Injection Site Pain
|
48.0%
503/1049 • Number of events 504 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
31.8%
334/1051 • Number of events 334 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
General disorders
Injection Site Swelling
|
7.8%
82/1049 • Number of events 82 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
17.6%
185/1051 • Number of events 185 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
General disorders
Malaise
|
9.7%
102/1049 • Number of events 103 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
5.6%
59/1051 • Number of events 59 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.8%
197/1049 • Number of events 197 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
12.4%
130/1051 • Number of events 130 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
|
Nervous system disorders
Headache
|
10.2%
107/1049 • Number of events 108 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
7.2%
76/1051 • Number of events 76 • Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.
|
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