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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ClinicalTrials.gov Identifier: NCT00197067 |
Recruitment Status
:
Completed
First Posted
: September 20, 2005
Last Update Posted
: June 2, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria | Biological: RTS,S/AS02D and RTS,S/AS02A | Phase 1 |
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 |

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Biological: RTS,S/AS02D and RTS,S/AS02A
- RTS
- S/AS02D and RTS
- S/AS02A
- 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.
- To assess antibody levels for relevant immunological indicators at time points when blood sampling will be done.

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

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
Mozambique | |
GSK Investigational Site | |
Maputo, Mozambique |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
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 |