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 Taiwanese Adults 65 Years of Age and Older (NCT NCT04537234)
NCT ID: NCT04537234
Last Updated: 2025-09-24
Results Overview
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
165 participants
Primary outcome timeframe
Day 0 (pre-vaccination)
Results posted on
2025-09-24
Participant Flow
The study was conducted at 4 active centers in Taiwan. A total of 165 participants were enrolled and randomized between 10 November 2020 to 12 January 2021.
A total of 165 participants were vaccinated in the study.
Participant milestones
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
83
|
|
Overall Study
COMPLETED
|
80
|
83
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
Participants received a single injection of 0.7 milliliters (mL) QIV-HD, intramuscularly (IM) at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
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 Taiwanese Adults 65 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.5 years
STANDARD_DEVIATION 5.37 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 5.71 • n=7 Participants
|
71.4 years
STANDARD_DEVIATION 5.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on the full analysis set (FAS) that included randomized participants who received one of the study vaccine and had a post-vaccination blood sample. Participants were analyzed according to the vaccine group to which they were randomized.
GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria Lineage), and B2 (B Yamagata Lineage). Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
A/H1N1
|
23.6 titers
Interval 18.1 to 30.6
|
24.1 titers
Interval 18.5 to 31.5
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
A/H3N2
|
111 titers
Interval 78.4 to 156.0
|
169 titers
Interval 120.0 to 238.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
B1
|
88.0 titers
Interval 66.7 to 116.0
|
98.2 titers
Interval 76.6 to 126.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0
B2
|
149 titers
Interval 111.0 to 199.0
|
160 titers
Interval 121.0 to 211.0
|
PRIMARY outcome
Timeframe: Day 28 (post-vaccination)Population: Analysis was performed on FAS.
GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
A/H3N2
|
643 titers
Interval 522.0 to 791.0
|
427 titers
Interval 324.0 to 563.0
|
|
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
B1
|
812 titers
Interval 645.0 to 1023.0
|
324 titers
Interval 253.0 to 414.0
|
|
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
B2
|
707 titers
Interval 595.0 to 840.0
|
361 titers
Interval 290.0 to 450.0
|
|
Geometric Mean Titers of Influenza Vaccine Antibodies at Day 28
A/H1N1
|
283 titers
Interval 221.0 to 364.0
|
109 titers
Interval 78.2 to 151.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination), Day 28 (post-vaccination)Population: Analysis was performed on FAS.
GMTRs of anti-influenza antibodies were measured by using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
A/H3N2
|
5.81 ratio
Interval 4.28 to 7.87
|
2.53 ratio
Interval 1.87 to 3.41
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
B1
|
9.23 ratio
Interval 7.0 to 12.2
|
3.30 ratio
Interval 2.48 to 4.39
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
B2
|
4.76 ratio
Interval 3.65 to 6.21
|
2.26 ratio
Interval 1.76 to 2.89
|
|
Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
A/H1N1
|
12.0 ratio
Interval 9.09 to 15.9
|
4.50 ratio
Interval 3.47 to 5.82
|
PRIMARY outcome
Timeframe: Day 28 (post-vaccination)Population: Analysis was performed on FAS.
Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage). Seroconversion was defined as either a pre-vaccination HAI titer less than (\<) 10 (1/dilution) at Day 0 and a post-vaccination titer greater than or equal to (\>=) 40 (1/dilution) at Day 28 or a pre-vaccination titer \>=10 (1/dilution) at Day 0 and a \>= four-fold increase in post-vaccination titer at Day 28.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
A/H1N1
|
86.3 percentage of participants
Interval 76.7 to 92.9
|
50.6 percentage of participants
Interval 39.4 to 61.8
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
A/H3N2
|
61.3 percentage of participants
Interval 49.7 to 71.9
|
28.9 percentage of participants
Interval 19.5 to 39.9
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
B2
|
50.0 percentage of participants
Interval 38.6 to 61.4
|
24.1 percentage of participants
Interval 15.4 to 34.7
|
|
Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
B1
|
78.8 percentage of participants
Interval 68.2 to 87.1
|
37.3 percentage of participants
Interval 27.0 to 48.7
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination)Population: Analysis was performed on FAS.
Antibody titer was measured by using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
A/H1N1
|
33.8 percentage of participants
Interval 23.6 to 45.2
|
36.1 percentage of participants
Interval 25.9 to 47.4
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
A/H3N2
|
76.3 percentage of participants
Interval 65.4 to 85.1
|
84.3 percentage of participants
Interval 74.7 to 91.4
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
B1
|
81.3 percentage of participants
Interval 71.0 to 89.1
|
85.5 percentage of participants
Interval 76.1 to 92.3
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 0
B2
|
85.0 percentage of participants
Interval 75.3 to 92.0
|
86.7 percentage of participants
Interval 77.5 to 93.2
|
PRIMARY outcome
Timeframe: Day 28 (post-vaccination)Population: Analysis was performed on FAS.
Antibody titer was measured using HAI assay method for 4 influenza virus strains: A/H1N1, A/H3N2, B1 (B Victoria lineage), and B2 (B Yamagata lineage).
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=80 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
A/H3N2
|
100 percentage of participants
Interval 95.5 to 100.0
|
96.4 percentage of participants
Interval 89.8 to 99.2
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
A/H1N1
|
97.5 percentage of participants
Interval 91.3 to 99.7
|
79.5 percentage of participants
Interval 69.2 to 87.6
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
B1
|
98.8 percentage of participants
Interval 93.2 to 100.0
|
98.8 percentage of participants
Interval 93.5 to 100.0
|
|
Percentage of Participants With Antibody Titers >=40 (1/Dilution) at Day 28
B2
|
100 percentage of participants
Interval 95.5 to 100.0
|
100 percentage of participants
Interval 95.7 to 100.0
|
PRIMARY outcome
Timeframe: Within 30 minutes post-vaccinationPopulation: Analysis was performed on the safety analysis set (SafAS) that included participants who had received one of the study vaccines and had any safety data available; and were analyzed according to the vaccine they actually received.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal 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 systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post-vaccinationPopulation: Analysis was performed on the SafAS. Here, 'Number analyzed' = participants with available data for each specified category.
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 protocol and CRB and considered as related to the product administered. Solicited injection site reactions included pain, erythema, swelling, induration, and bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site Pain
|
37 Participants
|
30 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site Induration
|
8 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Fever
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Headache
|
9 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Malaise
|
9 Participants
|
7 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Myalgia
|
22 Participants
|
10 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Shivering
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site Erythema
|
8 Participants
|
7 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site Swelling
|
8 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactions
Injection site Bruising
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 28 days post-vaccinationPopulation: Analysis was performed on the SafAS.
An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not had any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
|
8 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: From Day 0 up to 28 days post-vaccinationPopulation: Analysis was performed on the SafAS.
An 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. AESIs was defined as event for which ongoing monitoring and rapid communication by the investigator to the sponsor was done.
Outcome measures
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 Participants
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 Participants
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
AESIs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) Including Adverse Event of Special Interest (AESIs)
SAE
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: High-Dose Quadrivalent Influenza Vaccine (QIV-HD)
n=82 participants at risk
Participants received a single injection of 0.7 mL QIV-HD, IM at Day 0.
|
Group 2: Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD)
n=83 participants at risk
Participants received a single injection of 0.5 mL QIV-SD, IM at Day 0.
|
|---|---|---|
|
General disorders
Injection Site Erythema
|
9.8%
8/82 • Number of events 8 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
8.4%
7/83 • Number of events 7 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
General disorders
Injection Site Induration
|
9.8%
8/82 • Number of events 8 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
2.4%
2/83 • Number of events 2 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
General disorders
Injection Site Pain
|
45.1%
37/82 • Number of events 37 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
36.1%
30/83 • Number of events 30 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
General disorders
Injection Site Swelling
|
9.8%
8/82 • Number of events 8 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
2.4%
2/83 • Number of events 2 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
General disorders
Malaise
|
11.0%
9/82 • Number of events 9 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
8.4%
7/83 • Number of events 7 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
26.8%
22/82 • Number of events 22 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
12.0%
10/83 • Number of events 10 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
|
Nervous system disorders
Headache
|
11.0%
9/82 • Number of events 9 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
6.0%
5/83 • Number of events 5 • 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 (post-vaccination) up to 28 days post-vaccination.
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 protocol and CRB and considered as related to the product administered. 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. Analysis was performed on SafAS.
|
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