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Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age

NCT01310413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 842

Last updated 2021-11-01

Study results available
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Summary

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.

Conditions

Interventions

BIOLOGICAL

Influenza A (H5N1) Virus monovalent vaccine

All subjects will receive 2 doses administered as an intramuscular (IM) injection.

BIOLOGICAL

Saline placebo

All subjects will receive 2 doses administered as an intramuscular (IM) injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-07
Primary Completion
2011-07-21
Completion
2014-01-26

Countries

  • United States
  • Canada
  • Thailand

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 NCT01310413 on ClinicalTrials.gov