Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317473
Status:
COMPLETED
Last Update Posted:
2017-10-02
First Post:
2006-04-20
Brief Title:
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Double-blindRandomizedControlledDose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIRs MSP-1FMP1 Malaria Vaccine Adjuvanted in GSKs AS02A Versus Rabies Vaccine
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety and reactogenicity of the FMP-1AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
Detailed Description:
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 21 ration to receive one of three dose levels of FMP1AS02A 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSPC No HS171 | OTHER | Ethics Committee | None |
| HSRRB Log No A-12094 | OTHER | None | None |
| KEMRI SSC No 761 | OTHER | None | None |