Madhi, Shabir A.
Rivera, Luis M.
Sáez-Llorens, Xavier
Menéndez, Clara
Carrim-Ganey, Nazira
Cotton, Mark F.
Katzman, Darren
Luttig, Mariëtha M.
Candelario, Rosalba
Baker, Sherryl
Roychoudhury, Mahua
Funding for this research was provided by:
Novartis Vaccines Division
GlaxoSmithKline Biologicals SA
Article History
Received: 13 June 2017
Accepted: 29 December 2017
First Online: 15 January 2018
Ethics approval and consent to participate
: Written informed consent was obtained from all women, or their parent/legal representative if minors, prior to enrolment in the study. Informed assent was also obtained from women who were classified as minors. This study was conducted under the approval of the following institutional review boards or ethics committees: Comite de Docencia e Investigación, Hospital Santo Tomás, Panama; Consejo Nacional de Bioetica en Salud, the Dominican Republic; University of the Witwatersrand Human Research Ethics Committee (Medical), South Africa; Health Research Ethics Committee Research Development and Support Division, Stellenbosh University, South Africa; and National Bioethics Health Committee, Mozambique.
: Not applicable. The present manuscript does not contain any individual person’s data in any form.
: RC and MR were employees of the Novartis Vaccines Division at the time of the study. DK was an employee of the GSK group of companies. ML is an employee of the GSK group of companies. SB is a consultant statistician for the GSK group of companies GBS project. SM, XSL and MC declare having received grants from the Novartis Vaccines Division and the GSK group of companies for the work under consideration. Outside the work under consideration, SM declares having received grants from Pfizer, Novartis, Minervax and the Bill and Melinda Gates foundation for the conduct of clinical trials and personal fees for educational material from Medscape, MC declares having received grants from BMS, Gilead, VPM, Novavax, PATH, NIH and Penta for several pharmaceutical and vaccine studies and personal fees from ViiV and MSD for contribution to workshop and symposium. All other authors have no conflicts of interest to declare. On 2 March 2015 Novartis’ non-influenza Vaccines Business was acquired by the GSK group of companies.
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