Status:
COMPLETED
A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, When Administered to Children Aged 1 to 4 Years Living in a Malaria-endemic Region of Mozambique.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
1-4 years
Phase:
PHASE2
Brief Summary
Malaria is an important cause of death and serious illness among Mozambican children. Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be helpful if children ...
Detailed Description
In this study, the participating children will either receive either 3 doses of the new malaria vaccine or the control vaccine which has been selected because of its benefit to the children in prevent...
Eligibility Criteria
Inclusion
- Healthy male and female children, 1 to 4 years of age at the time of first vaccination (up to but not including 5th birthday).
- Written/thumbprinted and witnessed informed consent obtained from the parents or legal guardians.
Exclusion
- Major congenital defects or serious chronic illness.
- History of allergic reactions to vaccination or to any component of the Hiberix™, Prevnar® or Engerix-B™ vaccines.
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune modifying drugs within six months prior to the first vaccine dose .
- Previous vaccination with an experimental vaccine or with hepatitis B vaccine in children equal to or more than 18 months of age.
- Simultaneous participation in any other clinical trial.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
2022 Patients enrolled
Trial Details
Trial ID
NCT00197041
Start Date
July 1 2003
End Date
April 1 2005
Last Update
September 21 2016
Active Locations (1)
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1
GSK Investigational Site
Maputo, Mozambique