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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00380393 |
Purpose
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Biological: GSK malaria vaccine 257049 Vaccine Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Bio's Candidate Vaccine RTS,S/AS01, Administered According to a 0,1,2-mths Schedule in Children Aged 5 to 17 Mths Living in Tanzania & Kenya |
| Enrollment: | 855 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Group B: Active Comparator |
Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine
3 dose intramuscular injection
|
| Group A: Experimental |
Biological: GSK malaria vaccine 257049 Vaccine
3 dose intramuscular injection
|
Eligibility| Ages Eligible for Study: | 5 Months to 17 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Kenya | |
| GSK Investigational Site | |
| Kilifi, Kenya, 80108 | |
| Tanzania | |
| GSK Investigational Site | |
| Amani, Tanga, Tanzania | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 106464 |
| Study First Received: | September 25, 2006 |
| Last Updated: | September 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00380393 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Tanzania: TFDA (Tanzania Food and Drugs Authority); Kenya: Ministry of Health - Pharmacy and Poisons Board |
|
RTS S/AS01 Malaria Plasmodium Falciparum |
|
Protozoan Infections Coccidiosis Parasitic Diseases Malaria |