The vaccine or

placebo were administered as three doses on a 6-, 10-, 14-week CB-839 mouse schedule with the standard EPI vaccines, with the first dose being given at 4–12 weeks of age, and subsequent doses 4–10 weeks later. A total of 1136 infants received either vaccine or placebo in Bangladesh. Subjects were followed for efficacy and safety by field workers during monthly home visits following the first dose of study vaccine (the first participant enrolled in March 2007 and the last in March 2008) until the study close out visit in March 2009. Weight was collected at four time points during the study; by study vaccination staff at study vaccine doses one (5.3–10.8 weeks of age), two (9.1–17.5 weeks of age), and three (12.8–21.3 weeks of age), and by a field worker at the final home follow-up

visit in March 2009 (15–26 months of age); and birth weight was retrospectively collected based on information recorded on the mother’s health card when the delivery took place in a hospital. Weight at study doses two and three was measured as part of routine data collection for the Health and Demographic Surveillance System (HDSS) by the study vaccination staff and was recorded in the Matlab field site databases. Height was not collected as part of the trial. The vaccine trial was approved by Western Institutional Review Board (Olympia, WA, USA) and the Ethical Review Committee of the ICDDR,B. The Matlab field site, run by the OSI 906 ICDDR,B, is located 55 km south-east of Dhaka, and has a population of approximately 224,000 people [23]. A central treatment hospital treats approximately 15,000 cases of diarrhea each year, 60% of which are in children under five years of age [24]. found There are additional community treatment centres at Nayergaon and Kalirbazaar [23]. Stool samples are collected from all patients from the HDSS area who are admitted to the treatment facilities in Matlab, and are routinely tested for common enteric pathogens, including rotavirus [24]. Community health research workers (CHRWs) collect surveillance data through monthly household visits, and offer immunization

services in their home (a fixed-site clinic) twice per month [23]. We examined data collected on anthropometric measurements of infants enrolled in the Phase 3 trial. The additional anthropometry data collection and linking with Phase 3 data was approved as a separate protocol by the Institutional Review Board at the Johns Hopkins Bloomberg School of Public Health and the Ethical Review Committee of the ICDDR,B, and was not sponsored by Merck. Approximately one year following the end of the Phase 3 trial, in March and April 2010, field workers visited each of the enrolled subjects at their homes, obtained written informed consent from mothers or care givers interested in having their child participate, and collected final follow-up data on weight and height.