Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand.

"S.R., P.K., and W.J. clinical investigators involved in these studies received fees from Sanofi through their institutions for the conduct of this clinical study but did not receive any direct payment from Sanofi in this regard. J.L. is an employee of AIXIAL, who was contracted by Sanofi for the statistical aspects of this study. V.J.M. is an employee of Sanofi Healthcare India Private Ltd (SHIPL). L.S., Y.Y., K.V., S.M. and F.N. hold Sanofi stock and are employees of Sanofi."

"The study was funded by Sanofi."

"This Phase III, randomized, open-label study was conducted at 3 sites in Thailand (WHO UTN: U1111-1233-9694; ClinicalTrials.gov: NCT04429295). The study protocol and 2 amendments were approved by the appropriate institutional review board, and the study was performed according to ethical principles derived from international guidelines, including the Declaration of Helsinki and the International Council for Harmonization Guidelines for Good Clinical Practice. An informed consent form was signed by each participant’s parent(s) or legally acceptable representative(s) before enrolment. The study was conducted between June 2020 and May 2021."