Clinical Trials Directory

Trials / Completed

CompletedNCT01310413

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
842 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
6 Months – 17 Years
Healthy volunteers
Accepted

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

TypeNameDescription
BIOLOGICALInfluenza A (H5N1) Virus monovalent vaccineAll subjects will receive 2 doses administered as an intramuscular (IM) injection.
BIOLOGICALSaline placeboAll subjects will receive 2 doses administered as an intramuscular (IM) injection.

Timeline

Start date
2011-03-07
Primary completion
2011-07-21
Completion
2014-01-26
First posted
2011-03-08
Last updated
2021-11-01
Results posted
2014-03-31

Locations

17 sites across 3 countries: United States, Canada, Thailand

Source: ClinicalTrials.gov record NCT01310413. Inclusion in this directory is not an endorsement.