MedTrace Logo

Safety and Immunogenicity Study of GSK Biologicals' Malaria Vaccine 257049, When Incorporated Into an EPI Regimen

NCT00436007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2018-08-16

Study results available
· View outcomes & findings →

Summary

This study is being done to assess the possibility of the potential integration of malaria vaccine into the EPI regimen. It will evaluate whether the malaria vaccine is safe and immunogenic in infants aged 6 to 10 weeks at first dose, when co-administered with other EPI vaccine antigens. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

GSK 257049

GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine

BIOLOGICAL

Tritanrix™ HepB/Hib

GSK Biologicals' re-constituted diphtheria, tetanus, pertussis, hepatitis B vaccine (Tritanrix™ HepB) and Haemophilus influenzae type B vaccine (Hiberix™)

BIOLOGICAL

Rouvax™

Aventis Pasteur's attenuated measles vaccine.

BIOLOGICAL

Stamaril™

Aventis Pasteur's attenuated yellow fever vaccine.

BIOLOGICAL

Polio Sabin™

GSK Biologicals' oral polio virus vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-09-15
Completion
2009-10-07

Countries

  • Gabon
  • Ghana
  • 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 NCT00436007 on ClinicalTrials.gov