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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00307021 |
Purpose
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 |
|---|---|---|
|
Plasmodium Falciparum Malaria |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Group A |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
|
| Experimental: Group B |
Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
3-dose intramuscular injection, 2 different formulations
|
Eligibility| Ages Eligible for Study: | 18 Months to 48 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00307021 History of Changes |
| Other Study ID Numbers: | 105874 |
| Study First Received: | February 16, 2006 |
| Last Updated: | September 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Parasitic Diseases Malaria, Falciparum Malaria Coccidiosis |
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases |