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Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

NCT00971321 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2019-02-25

Study results available
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Summary

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

Conditions

Interventions

BIOLOGICAL

Pandemic influenza vaccine GSK2340272A

Two primary intramuscular (IM) injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-10
Primary Completion
2010-11-24
Completion
2010-11-24

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 NCT00971321 on ClinicalTrials.gov