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Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

NCT00317473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2017-10-02

Study results available
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Summary

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

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

FMP1/AS02A Malaria vaccine

Subjects vaccinated with FMP1/AS02 vaccine

BIOLOGICAL

Imovax Rabies vaccine

Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • GlaxoSmithKline

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Mark R. Withers, M.D., MPH · USAMRU-K

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2004-07-31
Completion
2005-07-31

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 NCT00317473 on ClinicalTrials.gov