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Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region

NCT00197028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-08-20

Study results available
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Summary

GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).

This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.

In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI) regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

RTS,S/AS02D

3-dose intramuscular injection in the thigh

BIOLOGICAL

TETRActHib™

3-dose intramuscular injection in the thigh.

BIOLOGICAL

Engerix-B®

3-dose intramuscular injection in the thigh.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-08-23
Primary Completion
2007-12-27
Completion
2007-12-27

Countries

  • Mozambique

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 NCT00197028 on ClinicalTrials.gov