CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Falciparum Malaria Protein 11 with AS02A adjuvantbiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Male or non-pregnant female 18 to 50 years of age (inclusive) at screening.
  • ✓Free of obvious health problems as established by medical history and clinical examination before entering the study.
  • ✓Female must be using birth control, surgically sterilized, or at least 1-year post menopausal.
  • ✓Available to participate for duration of study (approximately 15 months).
Key exclusion· 10
  • ✕Prior receipt of an investigational malaria vaccine.
  • ✕Any history of malaria.
  • ✕Known exposure to malaria within the previous 12 months.
  • ✕Planned travel to malarious areas during the study period.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00312702
NCT00312702Phase 2Completed
CompareCT.gov

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

U.S. Army Medical Research and Development Command·interventional·Posted Apr 10, 2006·Updated Nov 26, 2018

In Brief

A Phase 2 clinical trial evaluating Falciparum Malaria Protein 11 with AS02A adjuvant for Malaria and Plasmodium Falciparum Malaria. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Plasmodium Falciparum Malaria
CountriesUnited States
CollaboratorsGlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2006
Enrollment StartApr 1, 2006
Primary CompletionOct 1, 2006
Study CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.2 years ago

Interventions

Falciparum Malaria Protein 11 with AS02A adjuvantbiological

vaccine