Prior to conducting the study, the investigators received approvals from the DCGI, the Institutional Review Board for DBT, and the ethics review committees of each study site. The study partners also consulted with the State Governments of Delhi, Maharashtra, and Tamil Nadu, as well as the Ministry of Health and Family Welfare. In addition, the study was approved by the Western Institutional Review Board in the United States and met the highest international clinical trial standards. The DSMB strictly monitored the trial throughout for adherence to these standards and protocols. The trial design included a strong safety net to identify and treat illnesses, especially gastroenteritis, among study infants as early as possible. All of the infants enrolled in the trial received high-quality medical and emergency care during the trial period.
The support laboratory was the Translational Health Science and Technology Institute with Dr Sudhanshu Vrati as the lead. Quintiles was responsible for several aspects of the trial including medical monitoring, data management, site monitoring, pharmacovigilance, and biostatistics. Good Clinical Practice compliance of the clinical trials was audited by ANTHA Clinical Quality Assurance.
|Contact: Allison Clifford|