drugset / Trial / NCT03521973
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
Phase 2
Completed
200 enrolled
Sanaria Inc.
Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.
Timeline
- Start
- 2018-06-14
- Primary completion
- 2021-05-18
- Completion
- 2021-08-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfSPZ Vaccine | Vaccine | 900000 unknown | Other |