| Protocol No: | ECCT/14/09/01 | Date of Protocol: | 18-02-2014 |
| Study Title: | An open extension to the phase III, multi-center study MALARIA-055 PRI (110021) to evaluate long-term efficacy, safety and immunogenicity of the RTS,S/AS01E candidate vaccine against malaria disease caused by Plasmodium falciparum in infants and children in Africa. Study number: MALARIA-076 (200599) |
| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: | It is possible that vaccination with RTS,S/AS01E in infancy and early childhood may affect the rate of acquisition of natural immunity to malaria and there is a concern that vaccinees would have enhanced susceptibility to malaria relative to unvaccinated children of the same age. We intend to conduct long-term surveillance for malaria disease in participants to randomized controlled trial of RTS,S/AS01E. We will describe the patterns of clinical and severe forms in the long-term under different conditions of transmission. In total we will provide in children aged 5-17 months at first vaccination, approximately 7 years of follow-up post-Dose 1 (mean: 85 months; range: 77-91 months), and in infants aged 6-12 weeks at first vaccination, 6 years of follow-up post-Dose 1 (mean: 77 months; range: 68-84 months). |