An Extended Follow up of a RTS,S/AS01E Malaria Vaccine Trial (MAL059)
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ClinicalTrials.gov Identifier: NCT00872963 |
Recruitment Status : Unknown
Verified December 2015 by KEMRI-Wellcome Trust Collaborative Research Program.
Recruitment status was: Active, not recruiting
First Posted : April 1, 2009
Last Update Posted : December 7, 2015
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Condition or disease | Intervention/treatment |
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Malaria | Biological: RTS,S/AS01E |
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Extended Follow up of a Phase 2b Vaccine Trial With RTS,S/AS01E in Kilifi District, Kenya. |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | February 2016 |
Estimated Study Completion Date : | August 2016 |

Group/Cohort | Intervention/treatment |
---|---|
RABIES VACCINE
Those subjects who received the active comparator
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Biological: RTS,S/AS01E
0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule
Other Name: rabies vaccine BP, Sanofi-Pasteur |
RTS,S/AS01E
The subjects who received investigational product
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Biological: RTS,S/AS01E
0.5MLS of RTS,S/AS01E at 0,1,2 monthly schedule 0.5mls Rabies vaccine at 0,1,2 monthly schedule
Other Name: rabies vaccine BP, Sanofi-Pasteur |
- Long term febrile malaria episodes [ Time Frame: 4 years ]
- To compare the age distribution of episodes of malaria following vaccination with RTS,S with the age distribution following control vaccination. [ Time Frame: 4 years ]
- To compare the in vitro markers of naturally acquired immunity in vaccinated and unvaccinated children, and assess the associations of these markers with subsequent episodes of febrile malaria. [ Time Frame: 4 years ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 19 Months to 35 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Enrollment and vaccination in the RTS,S/AS01E clinical trial (NCT00380393)
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Exclusion Criteria:
- Moving out of the study area, so that follow up is impractical.

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): NCT00872963
Kenya | |
Kemri Wellcome Trust Research Programme | |
Kilifi, Coast Province, Kenya, 80108 |
Principal Investigator: | Ally Olotu | KEMRI-Wellcome Trust Collaborative Research Program |
Responsible Party: | KEMRI-Wellcome Trust Collaborative Research Program |
ClinicalTrials.gov Identifier: | NCT00872963 |
Other Study ID Numbers: |
SSC 1512 |
First Posted: | April 1, 2009 Key Record Dates |
Last Update Posted: | December 7, 2015 |
Last Verified: | December 2015 |
malaria vaccine RTS,S, |
Malaria Protozoan Infections Parasitic Diseases Infections |
Vector Borne Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |