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

NCT01218308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5220

Last updated 2018-08-01

Study results available
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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

Interventions

BIOLOGICAL

FluLaval® Quadrivalent

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

BIOLOGICAL

Havrix™

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-09
Primary Completion
2012-01-09
Completion
2012-01-09

Countries

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218308 on ClinicalTrials.gov