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NCT00443131

Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines

Completed Phase 2 Last updated 25 April 2017
What this trial tests

Phase 2 trial testing GSK Malaria vaccine 257049 in Malaria in 36 participants. Completed in 13 July 2007.

Timeline
26 March 2007
Primary endpoint
1 July 2007
13 July 2007

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment36
Start date26 March 2007
Primary completion1 July 2007
Estimated completion13 July 2007
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of the immune response to RTS,S/AS01 and RTS,S/AS02 adjuvanted vaccines: randomized, double-blind study in malaria-naïve adults.
    Leroux-Roels G, Leroux-Roels I, Clement F, Ofori-Anyinam O, et al · · 2014 · cited 52× · PMID 25424924 · DOI 10.4161/hv.29375
  2. A monoclonal antibody-based immunoassay to measure the antibody response against the repeat region of the circumsporozoite protein of Plasmodium falciparum.
    Radin K, Clement F, Jongert E, Sterckx YG, et al · · 2016 · cited 9× · PMID 27825382 · DOI 10.1186/s12936-016-1596-8

Verify or expand the search:

Other recruiting trials for Malaria

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00443131.

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