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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.

Primary Purpose

Malaria

Status
Completed
Phase
Phase 1
Locations
Mozambique
Study Type
Interventional
Intervention
RTS,S/AS02D and RTS,S/AS02A
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Malaria

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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

To assess antibody levels for relevant immunological indicators at time points when blood sampling will be done.

Full Information

First Posted
September 13, 2005
Last Updated
December 26, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00197067
Brief Title
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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2004 (Actual)
Primary Completion Date
April 26, 2005 (Actual)
Study Completion Date
April 26, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
RTS,S/AS02D and RTS,S/AS02A
Other Intervention Name(s)
RTS, S/AS02D and RTS, S/AS02A
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess antibody levels for relevant immunological indicators at time points when blood sampling will be done.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Maputo
Country
Mozambique

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study is available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD for this study is available via the Clinical Study Data Request site.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
IPD Sharing URL
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=19808

Learn more about this trial

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.

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