MedTrace Logo

A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.

NCT00197067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-12-27

No results posted yet for this study

Summary

GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum and also would provide protection against infection with hepatitis B virus. Studies conducted using the formulation RTS,S/AS02A (0.25 ml dose) in children and adults have shown to be safe. Currently all intramuscular vaccines in the EPI schedule are administered at a dose volume of 0.5 ml and in this context, a new variant of RTS,S/AS02D (0.5 ml dose) formulation has been composed which has the same active constituents in the same quantities as in a 0.25 ml dose of RTS,S/AS02A. In this study, RTS,S/AS02D (0.5 ml dose) was compared to the existing formulation, RTS,S/AS02A (0.25 ml dose).

Conditions

Interventions

BIOLOGICAL

RTS,S/AS02D and RTS,S/AS02A

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-15
Primary Completion
2005-04-26
Completion
2005-04-26

Countries

  • Mozambique

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 NCT00197067 on ClinicalTrials.gov