Trial Outcomes & Findings for Study of a Single Dose or Two Doses of a Quadrivalent Influenza Vaccine in Subjects Aged 6 Months or Older in India (NCT NCT02451358)
NCT ID: NCT02451358
Last Updated: 2022-04-19
Results Overview
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
400 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)
Results posted on
2022-04-19
Participant Flow
Study participants were enrolled in 8 centers in India from 27 July 2015 to 26 November 2016.
A total of 400 participants (100 in each group) were enrolled and vaccinated in the study.
Participant milestones
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
100
|
|
Overall Study
Vaccinated at Day 0
|
100
|
100
|
100
|
100
|
|
Overall Study
Vaccinated at Day 28
|
99
|
98
|
0
|
0
|
|
Overall Study
COMPLETED
|
99
|
98
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
Participants aged 6 to 35 months received 2 doses of 0.25 mL Quadrivalent Influenza Vaccine (QIV) (2016-2017 Northern Hemisphere (NH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 Southern Hemisphere (SH) formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=99 Participants
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=98 Participants
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=99 Participants
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 Participants
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
1.0 years
STANDARD_DEVIATION 0.8 • n=99 Participants
|
4.9 years
STANDARD_DEVIATION 1.5 • n=98 Participants
|
11.7 years
STANDARD_DEVIATION 2.2 • n=99 Participants
|
48.5 years
STANDARD_DEVIATION 18.8 • n=100 Participants
|
16.6 years
STANDARD_DEVIATION 21.2 • n=396 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
60 Participants
n=98 Participants
|
50 Participants
n=99 Participants
|
34 Participants
n=100 Participants
|
189 Participants
n=396 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
38 Participants
n=98 Participants
|
49 Participants
n=99 Participants
|
66 Participants
n=100 Participants
|
207 Participants
n=396 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
India
|
99 participants
n=99 Participants
|
98 participants
n=98 Participants
|
99 participants
n=99 Participants
|
100 participants
n=100 Participants
|
396 participants
n=396 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)Population: Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=99 Participants
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=98 Participants
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=99 Participants
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 Participants
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Pre-Vaccination: A/H1N1
|
14.4 Titers (1/dilutions)
Interval 9.83 to 21.1
|
84.1 Titers (1/dilutions)
Interval 53.6 to 132.0
|
107 Titers (1/dilutions)
Interval 83.4 to 138.0
|
44.3 Titers (1/dilutions)
Interval 31.8 to 61.6
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Pre-Vaccination: A/H3N2
|
44.4 Titers (1/dilutions)
Interval 26.6 to 74.2
|
416 Titers (1/dilutions)
Interval 311.0 to 555.0
|
204 Titers (1/dilutions)
Interval 150.0 to 277.0
|
20.8 Titers (1/dilutions)
Interval 15.8 to 27.3
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Pre-Vaccination: B Victoria
|
21.5 Titers (1/dilutions)
Interval 14.0 to 32.8
|
37.5 Titers (1/dilutions)
Interval 23.8 to 59.1
|
54.1 Titers (1/dilutions)
Interval 41.4 to 70.6
|
41.9 Titers (1/dilutions)
Interval 31.9 to 55.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Pre-Vaccination: B Yamagata
|
12.0 Titers (1/dilutions)
Interval 8.82 to 16.3
|
81.1 Titers (1/dilutions)
Interval 53.9 to 122.0
|
91.7 Titers (1/dilutions)
Interval 67.2 to 125.0
|
107 Titers (1/dilutions)
Interval 79.5 to 144.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Post-Vaccination: A/H1N1
|
723 Titers (1/dilutions)
Interval 527.0 to 993.0
|
1895 Titers (1/dilutions)
Interval 1550.0 to 2318.0
|
1641 Titers (1/dilutions)
Interval 1398.0 to 1927.0
|
1232 Titers (1/dilutions)
Interval 969.0 to 1565.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Post-Vaccination: A/H3N2
|
1016 Titers (1/dilutions)
Interval 697.0 to 1482.0
|
3458 Titers (1/dilutions)
Interval 3011.0 to 3971.0
|
2379 Titers (1/dilutions)
Interval 1994.0 to 2838.0
|
980 Titers (1/dilutions)
Interval 736.0 to 1306.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Post-Vaccination: B Victoria
|
658 Titers (1/dilutions)
Interval 441.0 to 982.0
|
2222 Titers (1/dilutions)
Interval 1820.0 to 2713.0
|
2061 Titers (1/dilutions)
Interval 1622.0 to 2617.0
|
1150 Titers (1/dilutions)
Interval 913.0 to 1447.0
|
|
Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies
Post-Vaccination: B Yamagata
|
951 Titers (1/dilutions)
Interval 675.0 to 1338.0
|
3582 Titers (1/dilutions)
Interval 3054.0 to 4201.0
|
2273 Titers (1/dilutions)
Interval 1750.0 to 2951.0
|
1836 Titers (1/dilutions)
Interval 1413.0 to 2385.0
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)Population: Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer \>=40 (1/dilution\[dil\]) at pre-vaccination and at post-final vaccination.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=99 Participants
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=98 Participants
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=99 Participants
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 Participants
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Pre-Vaccination: A/H1N1
|
23 Participants
|
62 Participants
|
86 Participants
|
60 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Pre-Vaccination: A/H3N2
|
40 Participants
|
94 Participants
|
85 Participants
|
34 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Pre-Vaccination: B Victoria
|
30 Participants
|
47 Participants
|
63 Participants
|
53 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Pre-Vaccination: B Yamagata
|
18 Participants
|
65 Participants
|
74 Participants
|
83 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Post-Vaccination: A/H1N1
|
93 Participants
|
98 Participants
|
99 Participants
|
99 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Post-Vaccination: A/H3N2
|
96 Participants
|
98 Participants
|
99 Participants
|
96 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Post-Vaccination: B Victoria
|
88 Participants
|
98 Participants
|
98 Participants
|
99 Participants
|
|
Number of Participants With Seroprotection to Influenza Vaccine Antigens
Post-Vaccination: B Yamagata
|
93 Participants
|
98 Participants
|
98 Participants
|
97 Participants
|
PRIMARY outcome
Timeframe: 28 days post-final vaccination (post-vaccination)Population: Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.
Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer \<10 (1/dil) and post-vaccination titer \>=40 (1/dil), and Significant increase was defined as pre-vaccination titer \>=10 (1/dil) and \>= 4-fold increase of post-vaccination titer.
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=99 Participants
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=98 Participants
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=99 Participants
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 Participants
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
A/H1N1
|
86 Participants
|
87 Participants
|
84 Participants
|
90 Participants
|
|
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
A/H3N2
|
85 Participants
|
77 Participants
|
71 Participants
|
90 Participants
|
|
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
B Victoria
|
84 Participants
|
87 Participants
|
95 Participants
|
92 Participants
|
|
Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens
B Yamagata
|
91 Participants
|
91 Participants
|
86 Participants
|
86 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after any vaccinationPopulation: Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, 'Number Analyzed' = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.
1. Solicited injection site reactions: * Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:\>=50 mm) * Age \>=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities \[age 2-11 years\], significant interference with daily activities \[age \>=12 years\]; Erythema and Swelling \>=50 mm \[age 2-11 years\], \>100 mm \[age \>=12 years\]) 2. Solicited systemic reactions: * Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:\>39.5 degree Celsius; Vomiting:\>=6 episodes/24 hours; Crying abnormal:\>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses \>=3 feeds/meals or most feeds/meals; Irritability: inconsolable) * Age \>=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever\>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)
Outcome measures
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=100 Participants
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=100 Participants
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=100 Participants
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 Participants
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Injection site Pain / Tenderness
|
12 Participants
|
40 Participants
|
35 Participants
|
24 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3: Injection site Pain / Tenderness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Injection site Erythema
|
1 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Injection site Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Injection site Swelling
|
2 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Injection site Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Fever
|
9 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Fever
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Vomiting
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Vomiting
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Crying abnormal
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Crying abnormal
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Drowsiness
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Drowsiness
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Appetite lost
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Appetite lost
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Irritability
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Irritability
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Headache
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Headache
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Malaise
|
0 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Malaise
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Myalgia
|
1 Participants
|
9 Participants
|
16 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Shivering
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine
Grade 3 Shivering
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Quadrivalent Influenza Vaccine Group 4: >=18 Years
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quadrivalent Influenza Vaccine Group 1: 6 to 35 Months
n=100 participants at risk
Participants aged 6 to 35 months received 2 doses of 0.25 mL QIV (2016-2017 NH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 2: 3 to 8 Years
n=100 participants at risk
Participants aged 3 to 8 years received 2 doses of 0.5 mL QIV (2016 SH formulation) intramuscularly, 1 injection each at Day 0 and 28.
|
Quadrivalent Influenza Vaccine Group 3: 9 to 17 Years
n=100 participants at risk
Participants aged 9 to 17 years received 1 dose of 0.5 mL QIV (2015-2016 NH formulation) intramuscularly, at Day 0.
|
Quadrivalent Influenza Vaccine Group 4: >=18 Years
n=100 participants at risk
Participants aged \>=18 years received 1 dose of 0.5 mL QIV (2015 SH formulation) intramuscularly, at Day 0.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
12.0%
12/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
40.0%
40/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
35.0%
35/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
24.0%
24/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Malaise
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
4.0%
4/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
7.0%
7/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
General disorders
Pyrexia
|
14.0%
14/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
8.0%
8/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
2.0%
2/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
5/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
3.0%
3/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.0%
1/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
9.0%
9/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
16.0%
16/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
3.0%
3/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
4.0%
4/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
6.0%
6/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
1.0%
1/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Psychiatric disorders
Irritability
|
6.0%
6/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
5.0%
5/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
0.00%
0/100 • Adverse events (AE) data were collected from Day 0 (post-vaccination) up to 28 days after the final vaccination (up to Day 56 for Group 1 and 2; Day 28 for Group 3 and 4)
A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER