MedTrace Logo

Efficacy of GSK Biologicals' Candidate Malaria Vaccine 257049 Against Malaria Disease in Infants and Children in Africa

NCT00866619 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15459

Last updated 2019-10-09

Study results available
· View outcomes & findings →

Summary

The purpose of this observer-blind study is to gather key efficacy, safety, and immunogenicity information on GSK's candidate malaria vaccine in infants and children.

Conditions

Interventions

BIOLOGICAL

Malaria Vaccine 257049

administered intramuscularly into the left deltoid.

BIOLOGICAL

Meningococcal C Conjugate Vaccine

administered intramuscularly into the left deltoid.

BIOLOGICAL

Cell-culture rabies vaccine

administered intramuscularly into the left deltoid.

BIOLOGICAL

TritanrixHepB/Hib

administered intramuscularly into the left deltoid.

BIOLOGICAL

Polio Sabin Oral Polio Vaccine (GSK)

administered orally.

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
17 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-27
Primary Completion
2011-03-01
Completion
2014-01-31

Countries

  • Burkina Faso
  • Gabon
  • Ghana
  • Kenya
  • Malawi
  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases
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 NCT00866619 on ClinicalTrials.gov