ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.
ClinicalTrials.gov Identifier: NCT00197067
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Malaria Biological: RTS,S/AS02D and RTS,S/AS02A Phase 1

Detailed Description:
Children participating in this study will either receive RTS,S/AS02D (0.5 ml dose) or RTS,S/AS02A (0.25 ml dose) intramuscularly according to 0, 1, 2 months schedule. The children will be followed-up throughout the study period to record safety events. Blood samples will be collected at defined time points to assess the subject's immune response to the relevant immunological indicators.

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Official Title: A Bridging 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 According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
Actual Study Start Date : March 15, 2004
Actual Primary Completion Date : April 26, 2005
Actual Study Completion Date : April 26, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    Biological: RTS,S/AS02D and RTS,S/AS02A
    Other Names:
    • RTS
    • S/AS02D and RTS
    • S/AS02A

Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Occurrence of solicited and unsolicited symptoms and serious adverse events during the entire study period; to assess antibody levels for relevant immunological indicators at time points when post completion of vaccination schedule.

Secondary Outcome Measures :
  1. To assess antibody levels for relevant immunological indicators at time points when blood sampling will be done.

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Healthy children of both sexes between the ages of 3 to 5 years (up to but not including 6th birthday) who had not previously been immunized with hepatitis B vaccine, whose parents or guardians the investigator believed could and would comply with the requirements of the protocol, whose parents or guardians would give written or oral, signed or thumb printed and witnessed informed consent, who were free of obvious health problems as established by medical history and clinical examination before entering into the study and who were available for the foreseen duration of the immunization and follow-up period.

Exclusion criteria:

If the child was found to have major congenital defects or serious chronic illness; history of surgical splenectomy; a diagnosis or clinical suspicion of an immunosuppressive or immunodeficient condition; family history of congenital or hereditary immunodeficiency; history of allergic disease or reactions likely to be exacerbated by any component of the vaccine; previous vaccination with hepatitis B vaccines or with an experimental vaccine; or if the child is simultaneously participating in any other clinical trial, then the child would be excluded from the study.

Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00197067


Locations
Mozambique
GSK Investigational Site
Maputo, Mozambique
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Results for study 257049/034 can be found on the GSK Clinical Study Register  This link exits the ClinicalTrials.gov site

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197067     History of Changes
Other Study ID Numbers: 257049/034
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases