Clinical Study to Evaluate the Efficacy, Safety and Immun... | NCT03165617

NCT03165617

ID	Type	Description	Link
2016-002883-15	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QIVc (≥2 years to <18 Years of Age)	Experimental	Cell-derived Seasonal Quadrivalent Influenza Vaccine	Biological: QIVc
Non-Influenza Comparator Vaccine	Active Comparator	Non-Influenza Comparator Vaccine	Biological: Non-influenza Comparator Vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QIVc	Biological	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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%.	Day 14 to Day 180 or until the end of the influenza season, whichever is longer
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	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	Day 14 to Day 180 or until the end of the influenza season, whichever is longer

Secondary Outcomes

Measure	Description	Time Frame
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	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female ≥2 to <18 years of age on the day of the first study vaccination
Subject's parent(s) or legal guardian(s) who was/were able to give informed consent/dissent after the nature of the study had been explained in accordance with the practices described in the study and according to local regulatory requirements
If the subject was of an age where, according to local regulations, informed assent was required, he/she must have provided assent to participate in the study
Subject/subject's parent(s) or legal guardian(s) was/were able to comply with study procedures and was/were available for follow-up; and
Subject was in generally good health as per the investigator's medical judgment

Exclusion Criteria:

Clinical signs of fever and/or an oral temperature of ≥100.4°F (38.0°C) within 3 days prior to vaccination;
A known history of any anaphylaxis, serious vaccine reactions or hypersensitivity to any of the vaccine components described in the Investigator's Brochure, or had any of the contraindications listed in the package insert of the comparator vaccine;
A history of Guillain-Barré syndrome or other de-myelinating diseases such as encephalomyelitis and transverse myelitis;
Female subject of childbearing potential (ie, post onset of menarche and before natural or induced menopause), sexually active, and who did not use any acceptable contraceptive methods for at least 2 months prior to study entry and who did not intend to use any acceptable contraceptive methods throughout subject participation (acceptable contraceptive methods included: abstinence; hormonal contraceptive [such as oral, injection, transdermal patch, implant]; diaphragm with spermicide; tubal occlusion device; intrauterine device [IUD]; tubal ligation; male partner using condom; or male partner having been vasectomized);
Pregnant or breast feeding female;
Subject and/or subject's parent/guardians who were not able to comprehend or follow all required study procedures for the entire period of the study;
Received prior Meningococcal ACWY vaccination that conflicted with national recommendations or local practices for the timing of the primary or the booster vaccination;
Received influenza vaccination or had documented influenza disease in the last 6 months;
Known or suspected congenital or acquired immunodeficiency; or received immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or systemic corticosteroid therapy (prednisone or equivalent) at any dose for more than 2 consecutive weeks (14 days) within the past 3 months. Topical, inhaled and intra-nasal corticosteroids were permitted. Intermittent use (1 dose in 30 days) of intra-articular corticosteroids was also permitted;
Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or administration was planned during the study;
Participated in any clinical study with another investigational product within 30 days prior to first study visit or intended to participate in another clinical study at any time during the conduct of this study. Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) was acceptable;
Medical conditions or treatments contraindicating IM vaccination due to increased risk of bleeding. These included known bleeding disorders (such as thrombocytopenia), or treatment with anticoagulants (such as warfarin) in the 3 weeks preceding vaccination. Antiplatelet agents such as low-dose aspirin, ticlopidine (Ticlid) and clopidogrel (Plavix) were permitted;
Evidence or history (within the previous 12 months) of drug or alcohol abuse;
Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who were financially or emotionally dependent on study staff;
Participated in this study in a prior season, if applicable; or
Any clinical condition that, in the opinion of the investigator, may have interfered with the results of the study or pose additional risk to the subject due to participation in the study.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Program Director	Seqirus	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
302 AusTrials Pty Ltd		Sherwood	Queensland	4075	Australia
300 Murdoch Childrens Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34644472	Derived	Nolan T, Fortanier AC, Leav B, Poder A, Bravo LC, Szymanski HT, Heeringa M, Vermeulen W, Matassa V, Smolenov I, Edelman JM. Efficacy of a Cell-Culture-Derived Quadrivalent Influenza Vaccine in Children. N Engl J Med. 2021 Oct 14;385(16):1485-1495. doi: 10.1056/NEJMoa2024848.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	QIVc (≥2 Years to <18 Years of Age)	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
FG001	Non-Influenza Comparator Vaccine

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 30, 2017	Sep 23, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

QIVc (≥2 years to <18 Years of Age)

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	QIVc (≥2 Years to <18 Years of Age)	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
BG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0008.7± 4.00 BG0018.9± 4.11 BG0028.8± 4.06

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001106 BG0011082 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00011 BG00111 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Philippines

Title	Measurements
	BG000902 BG001898 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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%.

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Units	Counts
Participants	OG0002257 OG0012252

Title

Denominators

Categories

Title	Measurements
	OG000175 OG001364

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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).					Absolute Efficacy	54.63			2-Sided	95	45.67	62.12					Superiority	Success criterion were met as the LL of the 2-sided 95% CI was above 20%.

Primary

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

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

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer

ID	Title	Description
OG000	QIVc (≥3 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Secondary

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

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.

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine

Secondary

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

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.

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Secondary

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

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

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use

Secondary

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

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.

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.

Posted

Number

Number of cases

Day 14 to Day 180 or until the end of the influenza season, whichever is longer.

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use
OG002

Secondary

Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay)

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.

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

Posted

Number

95% Confidence Interval

Geometric mean titers (GMTs)

Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses)

ID	Title	Description
OG000	QIVc (≥2 Years to <9 Years of Age) - Season 2	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.
OG001	Comparator (≥2 Years to <9 Years of Age) - Season 2

Secondary

ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects)

ID	Title	Description
OG000	QIVc (≥2 Years to <9 Years of Age) - Season 2	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.

Secondary

Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay)

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

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.

Posted

Number

95% Confidence Interval

Geometric mean ratio (GMR)

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)

ID	Title	Description
OG000	QIVc (≥2 Years to <9 Years of Age) - Season 2	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

Secondary

Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (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

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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)

ID	Title	Description
OG000	QIVc (≥2 Years to <9 Years of Age) - Season 2	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.

Secondary

Safety: Percentage of Subjects With Solicited Local and Systemic Adverse Events for 7 Days After Vaccination

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

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.

Posted

Number

Percentage of participants

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)

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Comparator (≥2 Years to <18 Years of Age)	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Secondary

Safety: Percentage of Subjects With Unsolicited AEs for 21 Days After Vaccination

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)

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

Posted

Number

Percentage of participants

Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects)

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001	Comparator (≥2 Years to <18 Years of Age)	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine

Secondary

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

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

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.

Posted

Number

Percentage of participants

Day 1 to Day 181 (for previously vaccinated subjects) or to Day 209 (for not previously vaccinated subjects)

ID	Title	Description
OG000	QIVc (≥2 Years to <18 Years of Age)	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
OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	QIVc (≥2 Years to <18 Years of Age)	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	0	2,258	25	2,258	871	2,258
EG001	Non-Influenza Comparator Vaccine	Non-Influenza Comparator Vaccine Non-influenza Comparator Vaccine: Non-influenza comparator vaccine for intramuscular use	1	2,255	30	2,255	963	2,255

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0010 events0 affected2,255 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Neuropathy, peripheral	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Speech disorder developmental	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Brain Edema	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0010 events0 affected2,255 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Status Migrainosus	Nervous system disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Unevaluable event	General disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Anorexia nervosa	Psychiatric disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Type I Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Pharyngitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0011 events1 affected2,255 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Chronic Tonsillitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Pneumonia	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0005 events5 affected2,258 at risk EG0013 events3 affected2,255 at risk
Dengue fever	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0002 events2 affected2,258 at risk EG0012 events2 affected2,255 at risk
Pneumonia mycoplasma	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0002 events2 affected2,258 at risk EG0010 events0 affected2,255 at risk
Appendicitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0012 events2 affected2,255 at risk
Appendicitis perforated	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Bronchitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0011 events1 affected2,255 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Dengue hemorrhagic fever	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0011 events1 affected2,255 at risk
Enterococcal Gastroenteritis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0001 events1 affected2,258 at risk EG0010 events0 affected2,255 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Impetigo	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Otitis media chronic	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Otitis media	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0012 events2 affected2,255 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0013 events3 affected2,255 at risk
Viral infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Non-systematic Assessment	EG0000 events0 affected2,258 at risk EG0011 events1 affected2,255 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Influenza like illness	General disorders	MedDRA 22.0	Non-systematic Assessment	EG000791 events791 affected2,258 at risk EG001894 events894 affected2,255 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG000111 events111 affected2,258 at risk EG001135 events135 affected2,255 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Non-systematic Assessment	EG000298 events298 affected2,258 at risk EG001270 events270 affected2,255 at risk

First MCP Posted Date

ID	Term
D007251	Influenza, Human

Non-Influenza Comparator Vaccine

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

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases