Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

Phase 2

Completed

• Conditions: Malaria
• Interventions: Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

• Registration Number: NCT00307021
• Lead Sponsor: GlaxoSmithKline

Brief Summary

GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-03-23
• Study First Posted: 2006-03-27
• Study Start: 2006-04-07
• Primary Completion: 2006-09-15
• Study Completion: 2007-08-22
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049	-
Group B	GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049	-

Primary Outcome Measures

Name	Time	Method
Occurrence of SAEs.	From the time of first vaccination until one month post Dose 3
Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).	One month post Dose 3.

Secondary Outcome Measures

Name	Time	Method
Anti-Hepatitis B surface agent (anti-HBs) antibody titers.	Prior to vaccination, one month post Dose 2 and one month post Dose 3.
Occurrence of unsolicited symptoms.	After each vaccination over a 30-day follow-up
Anti-CS antibody titers.	Prior to vaccination, one month post Dose 2
Occurrence of solicited general and local reactions.	Over a 7-day follow-up period after each vaccination.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇦 Lambaréné, Gabon