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Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

NCT01051661 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6154

Last updated 2021-02-26

Study results available
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Summary

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)

Intramuscular injection, one or two doses

BIOLOGICAL

GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)

Intramuscular injection, two doses

BIOLOGICAL

Placebo

Intramuscular injection, one dose

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
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-12
Primary Completion
2011-08-31
Completion
2011-09-09

Countries

  • Australia
  • Brazil
  • Colombia
  • Costa Rica
  • Mexico
  • Philippines
  • Singapore
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
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 NCT01051661 on ClinicalTrials.gov