Having HDSS identification number was instrumental for the assessment. All staff members underwent training to insure that they understood the nature of the study, the importance of accurate data collection and their performance was monitored by supervisors. In addition, external monitors assured that the data was accurate and was compliant with GCP. Collecting blood samples from those participating in the immunogenicity cohort posed some challenges but blood specimens were successfully collected by venipuncture

at all 41 fixed site clinics spread over in the entire study area. It was mandatory that blood samples need to be transferred to Matlab laboratory, centrifuged and to be stored in the refrigerator within two hours of collection. It was not an easy task and we had to arrange more than one transport to a FSC. This was the first time venous blood was Pictilisib manufacturer collected in the community at Matlab without any problem. Selleckchem PCI32765 The participant’s parent/guardian consented after full understanding of the study. A constraint faced by the team was continuation of the vaccination program through both rainy and hot seasons. The rains make travel difficult for the CHRW staff as well as the community participants who

must walk to the FSC. The very hot weather emphasizes the importance of maintaining the proper temperature of the vaccine while it is taken into the field. Though these factors represented challenges, they were managed successfully through careful planning. Our experience too with

this study indicates that a Phase III vaccine clinical efficacy study, with GCP standards, can be conducted while maintaining high quality and coverage in rural community level. The conduct of the study in this area with a long standing HDSS, and relationship with the communities in which the communities benefit from the services of the institution facilitates the ability to conduct such studies. This research study was funded by PATH’s Rotavirus Vaccine Programme, under a grant from the GAVI Alliance, and was co-sponsored by Merck. ICDDR,B acknowledges with gratitude the commitment of PATH to its research efforts. The study was designed and analyzed by scientists from Merck & Co., Inc, with substantial input from PATH staff and site investigators. PATH staff independently monitored study execution at sites and participated in pharmacovigilance and data analyses. We also acknowledge the sincere effort of all our study staffs and the support of the community members throughout the study area without which this study would ever have been materialized. Conflict of Interest Statement: MC, SR, and MJD were employees of Merck when the clinical trial was conducted; MC and MJD owned equity in the company. No other conflicts of interest are declared.