A phase II randomized, double-blind (observer blind), adjuvant justification study of RTS,S/AS01B and RTS,S/AS02A, candidate malaria vaccines, administered according to a 0, 1, 2 months schedule in malaria-naive adults aged 18 to 45 years

Femme et Homme

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Extrait

Immunogenicity • To demonstrate the superiority of anti-CS antibody response at 1 month post Dose 3 induced by RTS,S vaccine antigen formulated with AS01B adjuvant compared to RTS,S vaccine antigen reconstituted with saline. • To demonstrate the superiority of the anti-CS antibody response at 1 month post Dose 3 induced by RTS,S vaccine antigen formulated with AS02A adjuvant compared to RTS,S vaccine antigen reconstituted with saline. The primary objective of the trial is considered reached if 1 of the 2 co-primary objectives is met.

Critère d'inclusion

Malaria disease

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Kusajili – Centralise les essais cliniques mondiaux

A phase II randomized, double-blind (observer blind), adjuvant justification study of RTS,S/AS01B and RTS,S/AS02A, candidate malaria vaccines, administered according to a 0, 1, 2 months schedule in ma...