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Trial record 4 of 4 for:    seqirus | QIVc

Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165617
Recruitment Status : Completed
First Posted : May 24, 2017
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Seqirus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza, Human
Interventions Biological: QIVc
Biological: Non-influenza Comparator Vaccine
Enrollment 4514
Recruitment Details Subjects were enrolled over 3 seasons, starting in SH 2017, followed by NH 2017-2018 and NH 2018-2019. Recruitment was conducted in 8 countries over these 3 seasons: Australia, Philippines and Thailand (Season 1); Estonia and Finland i(Season 2); and Estonia, Finland, Lithuania, Poland and Spain (Season 3)
Pre-assignment Details  
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Hide Arm/Group Description

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Period Title: Overall Study
Started 2258 2256
Completed 2249 2247
Not Completed 9 9
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine Total
Hide Arm/Group Description

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Total of all reporting groups
Overall Number of Baseline Participants 2258 2256 4514
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2258 participants 2256 participants 4514 participants
8.7  (4.00) 8.9  (4.11) 8.8  (4.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants 2256 participants 4514 participants
Female
1106
  49.0%
1082
  48.0%
2188
  48.5%
Male
1152
  51.0%
1174
  52.0%
2326
  51.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants 2256 participants 4514 participants
Hispanic or Latino
11
   0.5%
11
   0.5%
22
   0.5%
Not Hispanic or Latino
2245
  99.4%
2245
  99.5%
4490
  99.5%
Unknown or Not Reported
2
   0.1%
0
   0.0%
2
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants 2256 participants 4514 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1106
  49.0%
1100
  48.8%
2206
  48.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.1%
2
   0.0%
Black or African American
1
   0.0%
0
   0.0%
1
   0.0%
White
1140
  50.5%
1139
  50.5%
2279
  50.5%
More than one race NA [1]  NA [1]  NA [2] 
Unknown or Not Reported
11
   0.5%
15
   0.7%
26
   0.6%
[1]
Data field not captured in the eCRF
[2]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2258 participants 2256 participants 4514 participants
Philippines
902
  39.9%
898
  39.8%
1800
  39.9%
Finland
168
   7.4%
158
   7.0%
326
   7.2%
Poland
147
   6.5%
151
   6.7%
298
   6.6%
Australia
96
   4.3%
99
   4.4%
195
   4.3%
Thailand
201
   8.9%
199
   8.8%
400
   8.9%
Lithuania
142
   6.3%
150
   6.6%
292
   6.5%
Estonia
599
  26.5%
599
  26.6%
1198
  26.5%
Spain
3
   0.1%
2
   0.1%
5
   0.1%
1.Primary Outcome
Title Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years
Hide Description

The primary efficacy endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season.

Dataset Used: FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

The success criterion used for this primary objective was as follows: The efficacy of the QIVc was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE was above 20%.

Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2257 2252
Measure Type: Number
Unit of Measure: Number of cases
175 364
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical Analysis title - Absolute Vaccine Efficacy Any Strain. Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 20% (primary endpoint) using the protocol definition of ILI for the entire age range (2 to <18 years of age).
Type of Statistical Test Superiority
Comments Success criterion were met as the LL of the 2-sided 95% CI was above 20%.
Method of Estimation Estimation Parameter Absolute Efficacy
Estimated Value 54.63
Confidence Interval (2-Sided) 95%
45.67 to 62.12
Estimation Comments [Not Specified]
2.Primary Outcome
Title Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years
Hide Description The co-primary efficacy endpoint: was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season.Absolute vaccine efficacy of QIVc by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain in subjects ≥3 years to <18 years of age
Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥3 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2208 2201
Measure Type: Number
Unit of Measure: Number of cases
171 351
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥3 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical analysis title - Absolute Vaccine Efficacy, Any Strain Adjusted aVE for QIVc vs. comparator. Success criteria for the primary efficacy endpoint was met if the LL of the 2-sided 95% CI of the aVE estimate was greater than 30% (co-primary endpoint) using the protocol definition of ILI for the entire age range (≥ 3 to <18 years of age).
Type of Statistical Test Superiority
Comments Success criteria was met as the LL of the 2-sided 95% CI of the VE estimate was greater than 30% (co-primary endpoint)
Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 54.03
Confidence Interval (2-Sided) 95%
44.8 to 61.71
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Hide Description

The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.

Dataset used: FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine QIVc (≥2 Years to <9 Years of Age) Comparator (≥2 Years to <9 Years of Age) QIVc (≥4 Years to <18 Years of Age) Comparator (≥4 Years to <18 Years of Age) QIVc (≥9 Years to <18 Years of Age) Comparator (≥9 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-influenza Comparator Vaccine:

Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2257 2252 1146 1142 2045 2032 1111 1110
Measure Type: Number
Unit of Measure: Number of cases
175 364 123 234 154 310 52 130
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 54.63
Confidence Interval (2-Sided) 95%
45.67 to 62.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <9 Years of Age), Comparator (≥2 Years to <9 Years of Age)
Comments Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 2 to <9yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 50.51
Confidence Interval (2-Sided) 95%
38.43 to 60.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QIVc (≥4 Years to <18 Years of Age), Comparator (≥4 Years to <18 Years of Age)
Comments Statistical analysis title: Absolute Vaccine Efficacy, Any Strain, 4 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 4 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 53.33
Confidence Interval (2-Sided) 95%
43.38 to 61.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QIVc (≥9 Years to <18 Years of Age), Comparator (≥9 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 9 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 61.85
Confidence Interval (2-Sided) 95%
47.37 to 72.34
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Hide Description

The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of RT-PCR-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years

Dataset used: FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.

Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine QIVc (≥2 Years to <9 Years of Age) Comparator (≥2 Years to <9 Years of Age) QIVc (≥4 Years to <18 Years of Age) Comparator (≥4 Years to <18 Years of Age) QIVc (≥9 Years to <18 Years of Age) Comparator (≥9 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2257 2252 1146 1142 2045 2032 1111 1110
Measure Type: Number
Unit of Measure: Number of cases
175 364 123 234 154 310 52 130
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <18yrs
Type of Statistical Test Superiority
Comments Absolute Vaccine Efficacy (aVE) for 2 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints
Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 54.63
Confidence Interval (2-Sided) 95%
45.67 to 62.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <9 Years of Age), Comparator (≥2 Years to <9 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <9yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <9 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 60.78
Confidence Interval (2-Sided) 95%
49.01 to 69.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QIVc (≥4 Years to <18 Years of Age), Comparator (≥4 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 4 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 59.66
Confidence Interval (2-Sided) 95%
49.08 to 68.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QIVc (≥9 Years to <18 Years of Age), Comparator (≥9 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 9 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 60.72
Confidence Interval (2-Sided) 95%
42.14 to 73.33
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Hide Description

The secondary endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.

Dataset used: FAS Efficacy

Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine QIVc (≥2 Years to <9 Years of Age) Comparator (≥2 Years to <9 Years of Age) QIVc (≥4 Years to <18 Years of Age) Comparator (≥4 Years to <18 Years of Age) QIVc (≥9 Years to <18 Years of Age) Comparator (≥9 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strain

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

QIVc: Cell-derived Quadrivalent Influenza Vaccine

for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-influenza Comparator Vaccine:

Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2257 2252 1146 1142 2045 2032 1111 1110
Measure Type: Number
Unit of Measure: Number of cases
115 279 79 190 101 237 36 89
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 60.81
Confidence Interval (2-Sided) 95%
51.3 to 68.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <9 Years of Age), Comparator (≥2 Years to <9 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <9yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 60.78
Confidence Interval (2-Sided) 95%
49.01 to 69.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QIVc (≥4 Years to <18 Years of Age), Comparator (≥4 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 9 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 59.66
Confidence Interval (2-Sided) 95%
49.08 to 68.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QIVc (≥9 Years to <18 Years of Age), Comparator (≥9 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 9 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 60.72
Confidence Interval (2-Sided) 95%
42.14 to 73.33
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine
Hide Description The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to influenza Type A or B strain antigenically matched to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to <18 years, 2 to <9 years, 4 to <18 years, and 9 to <18 years.
Time Frame Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine QIVc (≥2 Years to <9 Years of Age) Comparator (≥2 Years to <9 Years of Age) QIVc (≥4 Years to <18 Years of Age) Comparator (≥4 Years to <18 Years of Age) QIVc (≥9 Years to <18 Years of Age) Comparator (≥9 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 2257 2252 1146 1142 2045 2032 1111 1110
Measure Type: Number
Unit of Measure: Number of cases
90 236 64 164 81 200 26 72
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <18 Years of Age), Non-Influenza Comparator Vaccine
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <18 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 63.64
Confidence Interval (2-Sided) 95%
53.64 to 71.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection QIVc (≥2 Years to <9 Years of Age), Comparator (≥2 Years to <9 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 2 to <9yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 2 to <9 Years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 63.04
Confidence Interval (2-Sided) 95%
50.66 to 72.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection QIVc (≥4 Years to <18 Years of Age), Comparator (≥4 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 4 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 4 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 61.58
Confidence Interval (2-Sided) 95%
50.25 to 70.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection QIVc (≥9 Years to <18 Years of Age), Comparator (≥9 Years to <18 Years of Age)
Comments Statistical analysis title Absolute Vaccine Efficacy, Any Strain, 9 to <18yrs
Type of Statistical Test Superiority
Comments

Statistical analysis description:

Absolute Vaccine Efficacy (aVE) for 9 to <18 years. Note that no prespecified criteria for success were defined for the secondary efficacy endpoints

Method of Estimation Estimation Parameter Absolute Vaccine Efficacy
Estimated Value 64.78
Confidence Interval (2-Sided) 95%
44.84 to 77.51
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay)
Hide Description Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.
Time Frame Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses)
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Hide Analysis Population Description
FAS Immunogenicity - All Subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline at after the last vaccination
Arm/Group Title QIVc (≥2 Years to <9 Years of Age) - Season 2 Comparator (≥2 Years to <9 Years of Age) - Season 2 QIVc (≥2 Years to <9 Years of Age) - Season 3 Comparator (≥2 Years to <9 Years of Age) - Season 3
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 210 212 154 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Geometric mean titers (GMTs)
A/H1N1 Day 1 HI GMT
50.83
(41.89 to 61.66)
47.51
(39.15 to 57.64)
36.62
(22.61 to 59.31)
31.76
(19.88 to 50.74)
A/H1N1 Day 22/50 HI GMT
283.45
(249.22 to 322.38)
49.20
(43.24 to 55.98)
380.70
(283.12 to 511.91)
48.22
(36.14 to 64.32)
A/H3N2 Day 1 HI GMT
97.02
(86.51 to 108.81)
94.40
(84.19 to 105.84)
20.85
(15.99 to 27.20)
20.74
(16.02 to 26.85)
A/H3N2 Day 22/50 HI GMT
168.73
(150.87 to 188.70)
96.27
(86.05 to 107.70)
67.64
(57.03 to 80.24)
16.73
(14.17 to 19.77)
B/Victoria Day 1 HI GMT
11.67
(9.97 to 13.67)
11.73
(10.02 to 13.73)
9.54
(7.25 to 12.54)
9.41
(7.22 to 12.28)
B/Victoria Day 22/50 HI GMT
45.25
(39.73 to 51.54)
11.94
(10.48 to 13.60)
66.82
(51.29 to 87.04)
11.94
(9.23 to 15.44)
B/Yamagata Day 1 HI GMT
10.87
(9.46 to 12.50)
12.17
(10.59 to 13.99)
23.98
(16.74 to 34.36)
27.33
(19.27 to 38.76)
B/Yamagata Day 22/50 HI GMT
52.81
(45.77 to 60.94)
12.34
(10.68 to 14.24)
108.49
(85.16 to 138.22)
21.68
(17.11 to 27.46)
8.Secondary Outcome
Title ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay)
Hide Description

Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

Seroconversion was defined as: either a prevaccination HI titer <1:10 and a postvaccination HI titer

≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4 fold increase in postvaccination HI titer)

Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.

Time Frame Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects)
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Hide Analysis Population Description
FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <9 Years of Age) - Season 2 Comparator (≥2 Years to <9 Years of Age) QIVc (≥2 Years to <9 Years of Age) - Season 3 Non-Influenza Comparator Vaccine
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-influenza Comparator Vaccine:

Non-influenza comparator vaccine for intramuscular use

Overall Number of Participants Analyzed 210 212 154 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
59.5
(52.55 to 66.22)
1.9
(0.52 to 4.80)
74.0
(66.35 to 80.75)
6.2
(2.88 to 11.46)
A/H3N2
19.0
(13.97 to 25.02)
1.9
(0.52 to 4.80)
51.9
(43.76 to 60.06)
1.4
(0.17 to 4.89)
B/Victoria
40.0
(33.32 to 46.97)
2.9
(1.06 to 6.11)
58.4
(50.23 to 66.32)
3.4
(1.13 to 7.86)
B/Yamagata
49.5
(42.57 to 56.49)
4.8
(2.31 to 8.58)
58.4
(50.23 to 66.32)
1.4
(0.17 to 4.89)
9.Secondary Outcome
Title Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay)
Hide Description

Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

Geometric mean ratios (GMRs) measure the ratio in immunogenicity titers within subject\

Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.

Time Frame Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <9 Years of Age) - Season 2 Comparator (≥2 Years to <9 Years of Age) - Season 2 QIVc (≥2 Years to <9 Years of Age) - Season 3 Comparator (≥2 Years to <9 Years of Age) - Season 3
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 210 212 154 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Geometric mean ratio (GMR)
A/H1N1
5.76
(5.06 to 6.55)
1.00
(0.88 to 1.14)
9.73
(7.24 to 13.09)
1.23
(0.92 to 1.64)
A/H3N2
1.74
(1.56 to 1.95)
0.99
(0.89 to 1.11)
4.14
(3.49 to 4.91)
1.02
(0.87 to 1.21)
B/Victoria
3.79
(3.33 to 4.32)
1.00
(0.88 to 1.14)
7.01
(5.38 to 9.14)
1.25
(0.97 to 1.62)
B/Yamagata
4.63
(4.01 to 5.34)
1.08
(0.94 to 1.25)
5.27
(4.14 to 6.72)
1.05
(0.83 to 1.33)
10.Secondary Outcome
Title Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (HI Assay)
Hide Description

Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to <9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay.

The measures for assessing immunogenicity as determined by HI were as follows: Percentage of subjects with an HI titer ≥1:40 on Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains

Time Frame Day 1 (all subjects), Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated"subjects receiving 2 doses)
Hide Outcome Measure Data
Hide Analysis Population Description
Dataset used: FAS Immunogenicity = all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination.
Arm/Group Title QIVc (≥2 Years to <9 Years of Age) - Season 2 Comparator (≥2 Years to <9 Years of Age) - Season 2 QIVc (≥2 Years to <9 Years of Age) - Season 3 Comparator (≥2 Years to <9 Years of Age) - Season 3
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

** Strain compositions recommended by the World Health Organization for the 2018-2019 Northern Hemisphere influenza season (WHO, 2018) for quadrivalent vaccines.

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 210 212 154 145
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
A/H1N1
88.6
(83.47 to 92.54)
58.6
(51.59 to 65.31)
94.8
(90.02 to 97.73)
55.2
(46.70 to 63.43)
A/H3N2
90.0
(85.12 to 93.70)
92.4
(87.92 to 95.58)
74.0
(66.35 to 80.75)
24.8
(18.03 to 32.68)
B/Victoria
54.3
(47.29 to 61.16)
24.30
(18.65 to 30.66)
68.8
(60.88 to 76.04)
13.1
(8.08 to 19.70)
B/Yamagata
63.8
(56.91 to 70.31)
21.4
(16.08 to 27.60)
79.2
(71.95 to 85.33)
46.2
(37.90 to 54.67)
11.Secondary Outcome
Title Safety: Percentage of Subjects With Solicited Local and Systemic Adverse Events for 7 Days After Vaccination
Hide Description

The measures for assessing safety and tolerability were as follows: Percentage of subjects with solicited local and systemic adverse events (AEs) for 7 days after vaccination on Day 1 (for "previously vaccinated" subjects) or for 7 days after vaccination on Day 1 and Day 29 (for "not previously vaccinated" subjects) in the QIVc group and the non-influenza comparator vaccine group.

Dataset used: Solicited Safety Set

Time Frame days after vaccination on Day 1 (for "previously vaccinated" subjects) or for 7 days after vaccination on Day 1 and Day 29 (for "not previously vaccinated" subjects)
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Dataset used: Solicited Safety Set = All subjects in the Exposed Set who had gone through any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics.

Note: Other solicited adverse events refer to use of analgesics / antipyretics for prophylaxis or treatment.

Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Comparator (≥2 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 2255 2254
Measure Type: Number
Unit of Measure: Percentage of participants
Solicited AEs 51.4 48.6
Solicited Local AEs 36.8 33.6
Solicited Systemic AEs 31.4 30.5
Other 8.6 7.3
12.Secondary Outcome
Title Safety: Percentage of Subjects With Unsolicited AEs for 21 Days After Vaccination
Hide Description

The measures for assessing safety and tolerability were as follows: Percentage of subjects with unsolicited AEs assessed from Day 1 to Day 22 (for "previously vaccinated" subjects) or from Day 1 to Day 50 (for "not previously vaccinated" subjects) in the QIVc group and the non-influenza comparator vaccine group.

Dataset used: Unsolicited Safety Set (Unsolicited Adverse Events)

Time Frame Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects)
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Hide Analysis Population Description
Dataset used: unsolicited Safety Set defined as all subjects in the Exposed Set who had gone through any AE assessments, ie, a subject did not have to have any AEs to be included in this population
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Comparator (≥2 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 2258 2255
Measure Type: Number
Unit of Measure: Percentage of participants
Any AE 28.0 27.9
Any AE (Mild) 24.4 24.6
Any AE (Moderate) 4.8 4.5
Any AE (Severe) 0.5 0.5
Related AE 4.3 3.9
13.Secondary Outcome
Title Safety: Subjects With SAEs, AEs Leading to Withdrawal From Vaccination and/or the Study,(MAAEs) Within 30 Days of a 1st Occurrence, Post-ILI, and NOCDs Reported During Entire Study Participation or End of Flue Season, Whichever Was Longer
Hide Description

The measures for assessing safety and tolerability were as follows: Percentage of subjects with SAEs, AEs leading to withdrawal from vaccination and/or the study, Medically-Attended AEs (MAAEs) within 30 days after the first occurrence of an ILI, and New Onset of Chronic Diseases (NOCDs) reported during the subject's entire participation in the study (ie, from Day 1 to Day 181 [for "previously vaccinated" subjects] or from Day 1 to Day 209 [for "not previously vaccinated" subjects]), or until the end of influenza season, whichever was longer, and all medications associated with these events.

Dataset used: Overall Safety Set

Time Frame Day 1 to Day 181 (for previously vaccinated subjects) or to Day 209 (for not previously vaccinated subjects)
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Hide Analysis Population Description
Dataset used: overall safety set defined as all subjects in the Solicited Safety Set and/or Unsolicited Safety Set. Subjects providing only 30 minutes postvaccination safety data were also reported separately in a 30-minute postvaccination safety analysis.
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Comparator (≥2 Years to <18 Years of Age)
Hide Arm/Group Description:

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Overall Number of Participants Analyzed 2258 2255
Measure Type: Number
Unit of Measure: Percentage of participants
SAE 1.1 1.3
Related SAE 0 0
AE leading to study withdrawal 0 0
MAAE 27.2 30.1
NOCD 0.4 0.5
Death 0 0.04
Time Frame Day 1 through end of study
Adverse Event Reporting Description Adverse event reporting additional description: Nonserious Unsolicited AEs and SAEs are reported
 
Arm/Group Title QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Hide Arm/Group Description

Cell-derived Seasonal Quadrivalent Influenza Vaccine

QIVc: Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Non-Influenza Comparator Vaccine

Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

All-Cause Mortality
QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2258 (0.00%)      1/2255 (0.04%)    
Hide Serious Adverse Events
QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/2258 (1.11%)      30/2255 (1.33%)    
Gastrointestinal disorders     
Gastritis * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Irritable Bowel Syndrome * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Nausea * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
General disorders     
Unevaluable event * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Infections and infestations     
Pharyngitis * 1  1/2258 (0.04%)  1 1/2255 (0.04%)  1
Tonsillitis bacterial * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Chronic Tonsillitis * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Pneumonia * 1  5/2258 (0.22%)  5 3/2255 (0.13%)  3
Dengue fever * 1  2/2258 (0.09%)  2 2/2255 (0.09%)  2
Pneumonia mycoplasma * 1  2/2258 (0.09%)  2 0/2255 (0.00%)  0
Appendicitis * 1  1/2258 (0.04%)  1 2/2255 (0.09%)  2
Appendicitis perforated * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Bronchitis * 1  1/2258 (0.04%)  1 1/2255 (0.04%)  1
Campylobacter gastroenteritis * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Dengue hemorrhagic fever * 1  1/2258 (0.04%)  1 1/2255 (0.04%)  1
Enterococcal Gastroenteritis * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Gastrointestinal viral infection * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Gastroenteritis * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Gastroenteritis rotavirus * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Impetigo * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Otitis media chronic * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Otitis media * 1  0/2258 (0.00%)  0 2/2255 (0.09%)  2
Pneumonia bacterial * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Urinary tract infection * 1  0/2258 (0.00%)  0 3/2255 (0.13%)  3
Viral infection * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Injury, poisoning and procedural complications     
Clavicle fracture * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Hand fracture * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Contusion * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Ligament rupture * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Multiple fractures * 1  0/2258 (0.00%)  0 0/2255 (0.00%)  0
Skull fracture * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Metabolism and nutrition disorders     
Diabetic Ketoacidosis * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Type I Diabetes Mellitus * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Nervous system disorders     
Neuropathy, peripheral * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Speech disorder developmental * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Brain Edema * 1  0/2258 (0.00%)  0 0/2255 (0.00%)  0
Loss of consciousness * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Status Migrainosus * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Psychiatric disorders     
Anorexia nervosa * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  0/2258 (0.00%)  0 1/2255 (0.04%)  1
Skin and subcutaneous tissue disorders     
Drug eruption * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
Urticaria * 1  1/2258 (0.04%)  1 0/2255 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
QIVc (≥2 Years to <18 Years of Age) Non-Influenza Comparator Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   871/2258 (38.57%)      963/2255 (42.71%)    
General disorders     
Influenza like illness * 1  791/2258 (35.03%)  791 894/2255 (39.65%)  894
Infections and infestations     
Nasopharyngitis * 1  111/2258 (4.92%)  111 135/2255 (5.99%)  135
Upper respiratory tract infection * 1  298/2258 (13.20%)  298 270/2255 (11.97%)  270
1
Term from vocabulary, MedDRA 22.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Seqirus Clinical Trial Manager
Organization: Seqirus
Phone: 1-855-358-8966
EMail: seqirus.clinicaltrials@Seqirus.com
Layout table for additonal information
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT03165617    
Other Study ID Numbers: V130_12
2016-002883-15 ( EudraCT Number )
First Submitted: May 17, 2017
First Posted: May 24, 2017
Results First Submitted: September 23, 2020
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020