A Study to Evaluate Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02A, and RTS,S/AS01B, Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya.
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|ClinicalTrials.gov Identifier: NCT00197054|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Plasmodium Falciparum||Biological: RTS,S/AS02A and RTS,S/AS01B||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02A, and RTS,S/AS01B, Two Candidate Malaria Vaccines in Malaria-experienced Adults Living in Western Kenya.|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
- Safety of the vaccine up to 7 days post Dose 3.
- Safety of the vaccine upto 4 months post Dose 3. Antibody levels for relevant immunological indicators up to 4 months post Dose 3. Efficacy of the vaccine against malaria infection up to 4 months post Dose 3.
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): NCT00197054
|U.S. Army Research Unit-Kenya|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|