From the *Department of Science/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, Republic of South Africa; †Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Science, University of the Witwatersrand, Johannesburg, Republic of South Africa; ‡Benmed Hospital, Johannesburg, Republic of South Africa; and §Department of Clinical Development, Sanofi Pasteur, Marcy l'Etoile, France.
Accepted for publication December 14, 2010.
Supported by Sanofi Pasteur.
Sanofi Pasteur developed the protocol in conjunction with the study Investigators—Dr. Madhi, Dr. Mitha, Dr. Cutland, and Dr. Groome. Dr Eduardo Santos-Lima is employed by Sanofi Pasteur as Director, Clinical Development and Clinical Trial Leader for the investigational vaccine. The data were analyzed by Sanofi Pasteur in conjunction with the trial Investigators. As the Sponsor, Sanofi Pasteur paid for the conduct of the trial, but the Investigators received no direct payment from Sanofi Pasteur for conducting this study and have no financial ties to Sanofi Pasteur. The production of this publication was managed by Dr. Andrew Lane, who wrote the first draft and who is an employee of Sanofi Pasteur, with the full involvement of the Investigators and the Clinical Trial Leader. The manuscript was produced according to the International Committee of Medical Journal Editors (ICMJE) guidelines for authorship, the European Medical Writers Association guidelines and Good Publication Practice. Each Investigator has therefore been involved in the review of draft manuscripts and has approved the final manuscript. The study Investigators received honoraria from Sanofi Pasteur for conference attendance for the presentation of the data reported in this manuscript, or for the presentation of other Sanofi Pasteur-sponsored clinical trials in which they were involved, or for the attendance of specific seminars at such conferences.
ClinTrial.gov identifier: NCT00362336.
Presented at the 26th International Pediatric Association Congress of Pediatrics (IPACP); August 4–9, 2010; Johannesburg, South Africa.
Address for correspondence: Eduardo Santos-Lima, MD, Clinical Development, Sanofi Pasteur, 1541 Ave Marcel Mérieux, 69280 Marcy l'Etoile, France. E-mail: [email protected].
