Clinical Trial Search

Primary: Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population — 107…

Primary: Concentrations of Antibodies Against Hepatitis B (Anti-HB) — 13.0; 14.3; 16.9; 111.8 milli-international unit per milliliter

Primary: Part A Dose-Escalation: Number of Participants Who Experienced Any Serious Adverse Events Related To Vaccine Administration — 0; 0 Participants

Primary: Number of Participants With Solicited Adverse Events by Immunization and Type — 8; 18; 4; 13 Participants

Primary: Safety and Reactogenicity (SAEs and AEs) — 45; 53; 22; 37 Number of events

Primary: Number of Participants With Local and Systemic Adverse Events in Years 1 and 2 — 15; 14; 15; 15 Participants

Primary: Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination — 1; 0; 0; 1 Participants

Primary: Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination — 0; 5; 0; 12 Participants

Primary: Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. — 0; 0; 0; 0…

Primary: Time to First PCR-detectable Malaria Infection During the Active Detection of Infection (ADI) Phase in Groups 1 and 4 — 1.01; 1.49 Events per person year at risk — p=0.009

Primary: Safety - Most Frequently Reported Adverse Events and Grade — 3; 10; 0; 2 Number of adverse events

Primary: Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B — 0; 1 participants

Primary: Safety - Most Frequently Reported Adverse Events and Grade — 5; 9; 0; 4 adverse events

Primary: Number of Participants With Positive Sensitive Blood Smear (sBS) — 0; 0 Participants

Primary: Number of Participants With Solicited Adverse Events With Each Vaccination by Grade — 0; 0; 0; 0 Participants

Primary: Number of Local and Systemic Adverse Events (AEs) to Assess the Safety of the Study Drug — 34; 24; 23; 16 Adverse Events

Primary: Occurrence of Unsolicited Adverse Events (AEs), According to the Medical Dictionary for Regulatory Activities (MedRA) Classification. — 17; 6; 4 Participants

Primary: Number of Participants With Local and Systemic Adverse Events in Year One — 39; 27; 19; 11 Participants

Primary: Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination — 24; 11; 35; 15 events

Primary: Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge — 14; 10; 12 Participants — p=0.7675

Primary: Number of Participants With Possibly, Probably, or Definitely Related Serious Adverse Events (SAEs) — 0; 0 Participants

Primary: Number of Subjects With Serious Adverse Events (SAEs). — 17; 17 subjects

Primary: Number of Subjects Reported With Serious Adverse Events (SAEs) — 5; 4; 5; 7 Participants

Primary: Participants With Local Adverse Events (AEs) - Year One — 3; 1; 0; 0 Participants

Primary: Occurrence of Solicited Adverse Events Over a 7 Day Follow-up Period After Each Immunization (the Day of the Immunization and 6 Subsequent Days) During the Vaccination…

Primary: Number of Participants With Local and Systemic Adverse Events in Year 1 — 2; 6; 4; 6 Participants

Primary: Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Challenge — 4; 6; 12 Participants — p=<0.0001

Primary: Number of Participants With Adverse Events Within 7 Days After Each Vaccine Administration — 51; 43; 43 Participants

Primary: Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis) — 452.87; 422.49 EU/mL

Primary: Number of Serious Adverse Events and Grade 3 Adverse Events — 0; 0; 0; 0 adverse events