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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197041
First Posted: September 20, 2005
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 could be protected against malaria by a vaccine.

GSK Biologicals is developing in partnership with 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. Previous studies have shown the candidate malaria vaccine RTS,S/AS02 to be safe when administered in adults and children aged 1-11 years. However, to assess if this vaccine could provide protection against malaria in children, this study has been undertaken.


Condition Intervention Phase
Malaria Biological: RTS,S/AS02A Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, Administered Intramuscularly According to a 0, 1 and 2 Month Vaccination Schedule in Toddlers and Children Aged 1 to 4 Years in a Malaria-endemic Region of Mozambique.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to the first clinical episode of symptomatic Plasmodium falciparum malaria infection detected over the 6-month surveillance period after Dose 3 vaccination.

Secondary Outcome Measures:
  • Occurrence of episodes of asymptomatic and symptomatic infections of Plasmodium falciparum malaria. Occurrence of solicited symptoms, unsolicited symptoms and SAEs.

Enrollment: 2022
Study Start Date: July 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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 preventing important childhood diseases. The control vaccines include the following:

  • If the child is of 24 months or older, he/she may receive 3 doses of a vaccine, called Engerix-B™, which protects against hepatitis B.
  • If the child is less than 24 months, he/she may receive: two doses of a vaccine called Prevnar® and one dose of a vaccine called Hiberix™. Prevnar® prevents pneumonia and meningitis caused by some Streptococcus pneumoniae bacteria. Hiberix™ prevents severe infections such as pneumonia and meningitis caused by Haemophilus influenzae type b bacteria (Hib). All children will be monitored for the development of malaria disease over an 18-month period extending from the third vaccination. All participants will also be monitored for vaccine safety from first vaccination to study close.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197041


Locations
Mozambique
GSK Investigational Site
Maputo, Mozambique
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 257049/026
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197041     History of Changes
Other Study ID Numbers: 257049/026
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: September 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases