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Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

NCT00502593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2018-10-25

Study results available
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Summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

Pandemic Influenza Vaccine (GSK1562902A)

2 doses, intramuscular injection on Days 0 and 21, 3 different formulations are tested.

BIOLOGICAL

Fluarix™

2 doses, intramuscular injection on Days 0 and 21.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-07-23
Primary Completion
2009-12-04
Completion
2009-12-04

Countries

  • Spain

Study Locations

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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 NCT00502593 on ClinicalTrials.gov