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Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine

NCT00223990 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2021-02-12

Study results available
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Summary

This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.

Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.

This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.

One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).

Conditions

  • Malaria, Falciparum

Interventions

BIOLOGICAL

FMP1/AS02A

FMP1/AS02A candidate malaria vaccine

BIOLOGICAL

RabAvert

RabAvert rabies vaccine

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Kenya Medical Research Institute

    collaborator OTHER

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Bernhards Ogutu, M.D. · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-08
Primary Completion
2006-04-26
Completion
2007-06-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00223990 on ClinicalTrials.gov