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

NCT01218308 | Completed Phase 3 Results

• 1 other identifier: 114541
• Study Type: interventional
• Target: 5,220
• Locations: 8 countries
• Sites: 12

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

Keywords

Influenza

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B.

  To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

  From Day 14 to Day 180

Secondary Outcomes (18)

• Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B.

  From Day 14 to Day 180

• Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain.

  From Day 14 to Day 180

• Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain.

  From Day 14 to Day 180

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

  At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

• Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

  At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

Study Arms (2)

FluLaval® Quadrivalent Group

EXPERIMENTAL

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.

Biological: FluLaval® Quadrivalent

Havrix Group

ACTIVE COMPARATOR

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.

Biological: Havrix™

Interventions

FluLaval® Quadrivalent BIOLOGICAL

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

Also known as: Quadrivalent seasonal influenza vaccine GSK2282512A

FluLaval® Quadrivalent Group

Havrix™ BIOLOGICAL

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

Havrix Group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Dhaka, 1000, Bangladesh

Location

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

GSK Investigational Site

Tegucigalpa, Honduras

Location

GSK Investigational Site

Beirut, 1107-2020, Lebanon

Location

GSK Investigational Site

Panama City, Panama

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

GSK Investigational Site

Dasmariñas, Cavite, 4114, Philippines

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Adana, 1330, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 6100, Turkey (Türkiye)

Location

GSK Investigational Site

Eskişehir, Turkey (Türkiye)

Location

GSK Investigational Site

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 24328444 DERIVED

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 11, 2010
• Study Start: December 9, 2010
• Primary Completion: January 9, 2012
• Study Completion: January 9, 2012
• Last Updated: August 1, 2018
• Results First Posted: April 2, 2013

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

PH (2); TH (1); LE (1); TU (4); PA (1); BA (1); HO (1); DO (1)