Faust, Saul N.
Le Roy, Maguelone
Pancharoen, Chitsanu
Weber, Miguel Angel Rodriguez
Cathie, Katrina
Behre, Ulrich
Bernatoniene, Jolanta
Snape, Matthew D.
Helm, Klaus
Medina Pech, Carlos Eduardo
Henry, Ouzama
Baccarini, Carmen
Povey, Michael
Gillard, Paul
Article History
Received: 24 October 2018
Accepted: 31 January 2019
First Online: 7 February 2019
Ethics approval and consent to participate
: This study was approved by independent ethics committees/institutional review boards at each site (University of Tartu, Office of Research and Development; Landesarztekammer Baden-Wurttemberg Medical Board; National Institute of Pediatrics, Coyoacan; Medical Care and Research, Merida; Faculty of Medicine, Chulalongkorn University; NHS, Health Research Authority, North West-Liverpool East Research Ethics Committee) and conducted in accordance with provisions of the Declaration of Helsinki. Written informed consent was obtained from all children’s parents prior to enrolment in the study.
: Not applicable.
: MLR, OH, CB, MP and PG are employees of the GSK group of companies, and OH and PG hold shares in the GSK group of companies as part of their employee remuneration. CB was employed by the GSK group of companies during the conduct of this study and is a current employee of Sanofi Pasteur. She holds shares in the GSK group of companies and Sanofi Pasteur. SNF declares that his institution received grants from the GSK group of companies for the conduct of this trial. SNF also declares support through his institution for the conduct of other trials (from the GSK group of companies, Sanofi-Pasteur, Pfizer, AstraZeneca, MedImmune, Alios, Ablynx and Merck). SNF declares that his institution received other support from Pfizer, AstraZeneca, MedImmune, Sanofi, Sequerius and Merck for advisory board participation. MDS declares that his institution received grants from the GSK group of companies for the conduct of this trial. MDS also declares support through his institution for the conduct of other trials (from the GSK group of companies, Sanofi-Pasteur, Pfizer, MedImmune, Novavax and Johnson and Johnson). CP, MA RW, KC, UB, JB, KH and CE MP have indicated they have no financial relationship or conflict of interest relevant to this article to disclose.
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