A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS02A Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States

NCT00312702 Phase 1/Phase 2 COMPLETED Results posted

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	18
Start date	2006-04
Completion	2007-04

Conditions

• Malaria
• Plasmodium Falciparum Malaria

Interventions

• Falciparum Malaria Protein 11 with AS02A adjuvant

Primary outcomes

• Safety - Most Frequently Reported Adverse Events and Grade — 30 days post vaccination
  An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Countries

United States