To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
135
Subjects vaccinated with FMP1/AS02 vaccine
Subjects vaccinated on corresponding FMP1/AS02A vaccination days
Walter Reed Project Kombewa Clinic
Kombewa, Nyanza Province, Kenya
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Time frame: 40 days
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
Time frame: 90 days
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
Time frame: 8 months
Anti-FMP1 Antibody Titer Responses
Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine
Time frame: 364 days
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