The study was randomized, controlled, and double-blind and was prospectively registered at ClinicalTrials.gov . Approval was obtained from the Kenyan Medical Research Institute National Ethics Committee, the Tanzanian Medical Research Coordinating Committee, the Central Oxford Research Ethics Committee, the London School of Hygiene and Tropical Medicine Ethics Committee, and the Western Institutional Review Board in Seattle. An independent data and safety monitoring board and local safety monitors were appointed. The study was conducted in accordance with the Helsinki Declaration of 1964 (revised in 1996) and according to Good Clinical Practice guidelines.
GlaxoSmithKline Biologicals was the study sponsor. The database was managed by the sponsor and was opened to the principal investigators at the time of unblinding. Analysis was performed in parallel by an industry author who is an employee of the sponsor and an academic author. Two academic authors and the industry author vouch for the data and analysis. The first draft of the manuscript was written by an academic author, who subsequently implemented revisions from all the authors after their review.
GlaxoSmithKline and both study sites (Kilifi, Kenya, and Korogwe, Tanzania) received funding to undertake the work described in this report from the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative (MVI), which was involved in all aspects of the study design. Permission to submit the manuscript for publication was given by the directors of the Kenya Medical Research Institute and the National Institute for Medical Research of Tanzania. More details of the investigators' and sponsor's roles in the study are given in theSupplementary Appendix , available with the full text of this article at www.nejm.org .
GlaxoSmithKline Biologicals was the study sponsor. The database was managed by the sponsor and was opened to the principal investigators at the time of unblinding. Analysis was performed in parallel by an industry author who is an employee of the sponsor and an academic author. Two academic authors and the industry author vouch for the data and analysis. The first draft of the manuscript was written by an academic author, who subsequently implemented revisions from all the authors after their review.
GlaxoSmithKline and both study sites (Kilifi, Kenya, and Korogwe, Tanzania) received funding to undertake the work described in this report from the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative (MVI), which was involved in all aspects of the study design. Permission to submit the manuscript for publication was given by the directors of the Kenya Medical Research Institute and the National Institute for Medical Research of Tanzania. More details of the investigators' and sponsor's roles in the study are given in the
