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Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children

NCT00360230 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2018-02-19

Study results available
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Summary

This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

2 different formulations are tested. For each formulation, 3 different dosing schedules are tested

BIOLOGICAL

Rabipur

3-dose intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
17 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-30
Primary Completion
2007-08-25
Completion
2008-05-30

Countries

  • Ghana

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 NCT00360230 on ClinicalTrials.gov