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Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine

NCT00323622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1737

Last updated 2016-12-09

Study results available
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Summary

The RTS,S/AS02A vaccine (or GSK 257049 vaccine), GSK Biologicals' candidate Plasmodium falciparum (P. falciparum) malaria vaccine is being developed 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 P. falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).

This phase IIb trial is being carried out following the demonstration of efficacy of the candidate malaria vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.

In this study, the children from Mozambique (NCT= NCT00197041) are followed-up to assess the safety, immunogenicity and efficacy of the candidate malaria vaccine for a two year period commencing 21 months after Dose 1.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 2. During this extension study, no new subjects will be recruited and no vaccine will be administered.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

IM injection in the deltoid muscle

BIOLOGICAL

Engerix™-B

IM injection in the deltoid muscle

BIOLOGICAL

Hiberix®

IM injection in the deltoid muscle

BIOLOGICAL

Prevnar™

IM injection in the deltoid muscle

DRUG

sulfadoxine-pyrimethamine

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

DRUG

amodiaquine

1 dose orally per day for 3 days, 4 weeks prior to onset of surveillance

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
33 Months
Max Age
69 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Mozambique

Study Locations

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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 NCT00323622 on ClinicalTrials.gov