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Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

NCT00976820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2017-12-12

Study results available
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Summary

The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.

This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.

Conditions

  • Influenza

Interventions

BIOLOGICAL

GSK2340274A

Two intramuscular injections

BIOLOGICAL

GSK2340273A

Two intramuscular injections

Sponsors & Collaborators

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-20
Primary Completion
2011-03-21
Completion
2011-03-21

Countries

  • United States
  • Canada

Study Locations

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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 NCT00976820 on ClinicalTrials.gov