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Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

NCT00764790 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3317

Last updated 2018-07-31

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Conditions

Interventions

BIOLOGICAL

Fluarix

One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.

BIOLOGICAL

Fluzone

One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-01
Primary Completion
2009-03-05
Completion
2009-06-01

Countries

  • United States
  • Hong Kong
  • Mexico
  • Taiwan
  • Thailand

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 NCT00764790 on ClinicalTrials.gov