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Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children

NCT01003418 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-02-15

Study results available
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Summary

The purpose of this study is to assess the safety and immunogenicity of two doses of the H1N1 candidate vaccine administered in children aged between 8 and 12 weeks at the time of first vaccination.

Conditions

Interventions

BIOLOGICAL

GSK2340272A GSK Biologicals' investigational influenza pandemic vaccine

Two doses; intramuscular administration

BIOLOGICAL

Infanrix™-IPV/Hib

Routine infant immunisation vaccine, three doses administered intramuscularly

BIOLOGICAL

Prevenar

Routine infant immunisation vaccine, three doses administered intramuscularly

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-17
Primary Completion
2010-11-25
Completion
2010-11-25

Countries

  • Norway

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 NCT01003418 on ClinicalTrials.gov