CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Falciparum Malaria Protein 11 with AS01B adjuvant.biological
Likely dose
FMP011/AS01B (falciparum malaria protein 11 with AS01B adjuvant) — specific dose not stated in published recordAI-extracted
Key inclusion· 4
  • ✓Male or non-pregnant female aged 18–50 years at screening
  • ✓Free of obvious health problems per medical history and clinical examination
  • ✓Available for ~15 months of study participation
  • ✓Female participants must use birth control, be surgically sterilized, or be ≥1 year post-menopausal
Key exclusion· 9
  • ✕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/NCT00312663
NCT00312663Phase 2Completed
CompareCT.gov

A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B 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 AS01B adjuvant. for Plasmodium Falciparum Malaria. Completed, enrolled 24 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--
ConditionsPlasmodium 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 AS01B adjuvant.biological

malaria experimental vaccine