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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00307021 |
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.
Condition | Intervention | Phase |
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Plasmodium Falciparum |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years |
Enrollment: | 180 |
Study Start Date: | April 2006 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Active Comparator |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
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Group B: Experimental |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
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Ages Eligible for Study: | 18 Months to 4 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 105874 |
Study First Received: | February 16, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00307021 |
Health Authority: | United States: Food and Drug Administration |
Malaria Coccidiosis Malaria, Falciparum Parasitic Diseases |
Protozoan Infections Parasitic Diseases Malaria Malaria, Falciparum |
Coccidiosis |