A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

NCT ID: NCT01218308

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 5220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-09
• Study Completion Date: 2012-01-09

Brief Summary

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.

This study will also evaluate the immunogenicity and safety of the investigational vaccine.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

FluLaval® Quadrivalent Group

Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Group Type: EXPERIMENTAL

FluLaval® Quadrivalent

Intervention Type: BIOLOGICAL

One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.

Havrix Group

Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.

Group Type: ACTIVE_COMPARATOR

Havrix™

Intervention Type: BIOLOGICAL

Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.

Interventions

FluLaval® Quadrivalent

One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.

Intervention Type: BIOLOGICAL

Havrix™

Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.

Intervention Type: BIOLOGICAL

Other Intervention Names

Quadrivalent seasonal influenza vaccine GSK2282512A

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
• A male or female child aged between 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
• Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
• Written assent obtained from the subject if/as required by local regulations.
• Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
• Access to a consistent means of telephone contact

Exclusion Criteria

• Child in care.
• Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
• Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at >=12 months of age.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
• Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
• Fever at the time of enrolment.
• Acute disease at the time of enrolment.
• Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Ongoing aspirin therapy.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Dhaka, , Bangladesh

GSK Investigational Site

Santo Domingo, , Dominican Republic

GSK Investigational Site

Tegucigalpa, , Honduras

GSK Investigational Site

Beirut, , Lebanon

GSK Investigational Site

Panama City, , Panama

GSK Investigational Site

City of Muntinlupa, , Philippines

GSK Investigational Site

Dasmariñas, Cavite, , Philippines

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Adana, , Turkey (Türkiye)

GSK Investigational Site

Ankara, , Turkey (Türkiye)

GSK Investigational Site

Eskişehir, , Turkey (Türkiye)

GSK Investigational Site

Izmir, , Turkey (Türkiye)

Countries

Bangladesh; Dominican Republic; Honduras; Lebanon; Panama; Philippines; Thailand; Turkey (Türkiye)

References

Jain VK, Rivera L, Zaman K, Espos RA Jr, Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, Cravioto A, Yunus M, Chanthavanich P, Limkittikul K, Kurugol Z, Alhan E, Caplanusi A, Durviaux S, Boutet P, Ofori-Anyinam O, Chandrasekaran V, Dbaibo G, Innis BL. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013 Dec 26;369(26):2481-91. doi: 10.1056/NEJMoa1215817. Epub 2013 Dec 11.

Reference Type: DERIVED

PMID: 24328444 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

114541

Identifier Type: -

Identifier Source: org_study_id