CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 135 enrolled
Drug / intervention
FMP1/AS02A Malaria vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00317473
NCT00317473Phase 1Completed
CompareCT.gov

Double-blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR's MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine.

U.S. Army Medical Research and Development Command·interventional·Posted Apr 24, 2006·Updated Oct 2, 2017

In Brief

A Phase 1 clinical trial evaluating FMP1/AS02A Malaria vaccine and Imovax Rabies vaccine for Plasmodium Falciparum Malaria. Completed, enrolled 135 participants across 1 site.

Detailed Summary

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPlasmodium Falciparum Malaria
CountriesKenya
CollaboratorsKenya Medical Research Institute, Walter Reed Army Institute of Research (WRAIR), The PATH Malaria Vaccine Initiative (MVI), United States Agency for International Development (USAID), GlaxoSmithKline

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2006
Enrollment StartJun 1, 2003
Primary CompletionJul 1, 2004
Study CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.2 years ago

Interventions

FMP1/AS02A Malaria vaccinebiological

Subjects vaccinated with FMP1/AS02 vaccine

Imovax Rabies vaccinebiological

Subjects vaccinated on corresponding FMP1/AS02A vaccination days