At a glance
ClinicalIndex Comparison Record- ✓Healthy male or female child aged 12-47 months at screening
- ✓Written informed consent from at least one parent/guardian
- ✓Available for ~14 months study duration
- ✕Acute disease at entry that poses threat to subject
- ✕Prior rabies vaccine or investigational vaccine receipt
- ✕Investigational drug/vaccine within 30 days before first dose or within 30 days after third dose (except study vaccine)
- ✕Chronic immunosuppressants (>14 days) or immune-modifying drugs within 6 months of vaccination; prednisone ≥0.5 mg/kg/day excluded
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Dbl-blind,Randomized,Controlled,Phase IIb Field Trial in 12-47 Month-old Children in Western Kenya to Eval the Efficacy,Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine vs Rabies Vaccine
In Brief
A Phase 2 clinical trial evaluating FMP1/AS02A and RabAvert for Malaria, Falciparum. Completed, enrolled 400 participants across 1 site.
Detailed Summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions. This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination. One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
Study Details
Timeline
Interventions
FMP1/AS02A candidate malaria vaccine
RabAvert rabies vaccine