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Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

NCT ID: NCT01711736

Last Updated: 2021-11-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-01

Study Completion Date

2013-06-19

Brief Summary

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The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Detailed Description

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The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).

Conditions

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Influenza

Keywords

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Immunogenicity Children Safety Seasonal influenza Fluarix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GSK2282512A Group

Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.

Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

Group Type EXPERIMENTAL

Quadrivalent influenza GSK2282512A vaccine

Intervention Type BIOLOGICAL

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Fluarix Group

Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.

Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects \< 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

Group Type ACTIVE_COMPARATOR

Fluarix

Intervention Type BIOLOGICAL

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Interventions

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Quadrivalent influenza GSK2282512A vaccine

1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Intervention Type BIOLOGICAL

Fluarix

1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject's parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* A male or female between, and including, 6 and 35 months of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Subjects in stable health as determined by the investigator's clinical examination and assessment of subject's medical history.
* Subjects are eligible regardless of history of administration of influenza vaccine in a previous season.

Exclusion Criteria

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations are permitted.
* Child in care.
* Prior receipt of any seasonal or pandemic influenza vaccine within six months preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dosed.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barré syndrome within six weeks of receipt of prior influenza vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Acute disease and/or fever at the time of enrolment.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Halifax, Nova Scotia, Canada

Site Status

GSK Investigational Site

Brampton, Ontario, Canada

Site Status

GSK Investigational Site

Greater Sudbury, Ontario, Canada

Site Status

GSK Investigational Site

Hamilton, Ontario, Canada

Site Status

GSK Investigational Site

Mirabel, Quebec, Canada

Site Status

GSK Investigational Site

Québec, Quebec, Canada

Site Status

GSK Investigational Site

Santo Domingo, Distrito Nacional, , Dominican Republic

Site Status

GSK Investigational Site

San Pedro Sula, , Honduras

Site Status

Countries

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Canada Dominican Republic Honduras

References

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Bekkat-Berkani R, Ray R, Jain VK, Chandrasekaran V, Innis BL. Evidence update: GlaxoSmithKline's inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 2016;15(2):201-14. doi: 10.1586/14760584.2016.1113878. Epub 2015 Dec 5.

Reference Type BACKGROUND
PMID: 26641539 (View on PubMed)

Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.

Reference Type BACKGROUND
PMID: 26336604 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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2013-003155-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116926

Identifier Type: -

Identifier Source: org_study_id