Clinical trial
Phase I Pediatric FMP2.1/AS02A Trial in Mali
NCT00358332 · U.S. Army Medical Research and Development Command, U.S. Fed · Completed
Key facts
| NCT number | NCT00358332 |
|---|---|
| Title | Phase I Pediatric FMP2.1/AS02A Trial in Mali |
| Official title | Randomized, Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of WRAIR's AMA-1 Malaria Vaccine (FMP2.1) Adjuvanted in GSKBio's AS02A Vs. Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali |
| Lead sponsor | U.S. Army Medical Research and Development Command, U.S. Fed |
| Collaborators | National Institute of Allergy and Infectious Diseases (NIAID) NIH Walter Reed Army Institute of Research (WRAIR) U.S. Fed GlaxoSmithKline Industry University of Maryland, Baltimore |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Plasmodium Falciparum Malaria |
| Intervention type | Biological |
| Interventions | FMP2.1/AS02A, Rabies vaccine (RabAvert) |
| Enrollment | 100 |
| Start date | Nov 1, 2006 |
| Primary completion | Dec 1, 2007 |
| Completion | Dec 1, 2007 |
| First posted | Jul 31, 2006 |
| Last update posted | Oct 24, 2011 |
| Countries | Mali |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: