Study design and participants
diarrhoea, infection, vomiting, immunodeficiency disorder
INFECTION, DISEASE, IMMUNODEFICIENCY DISORDER
We did a randomised, double-blind, phase 2 clinical study at the Matlab Health Research Center in Chandpur, rural Bangladesh. The protocol was approved by the research review committee and the ethical review committee at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b).Women in the third trimester of their pregnancy were identified by local community health workers and had study objectives and procedures explained to them before they were invited to enrol their infant. Enlisted pregnant women were requested to give birth at the Matlab hospital or subcentre, icddrb, and were asked to enrol their newborn infant for study vaccination within 0–3 days of birth. Eligibility criteria for the mother required willingness and ability to comply with the study procedures and provision of consent for their infant to participate for the entire duration of the study. Eligibility criteria for newborn infants at screening were that they were healthy and were a single birth after at least 37 weeks' gestation. Major exclusion criteria included receipt of rotavirus or any other poliovirus vaccine, any infection or illness at the time of enrolment (vomiting, diarrhoea, or intolerance to liquids), diagnosis or suspicion of any immunodeficiency disorder in the infant or a close family member, or any contraindication for venipuncture (This study was done in compliance with the relevant regulatory requirements and the International Council for Harmonisation Good Clinical Practice guidelines of the Declaration of Helsinki for biomedical research involving human subjects under the guidance of the icddr,b data and safety monitoring board. All parents and guardians who volunteered their children to participate provided written informed consent before enrolment. This study is registered on 