We are grateful for thoughtful input to the manuscript from Umesh Parashar. Contributors: We benefited from the work of the Data Safety Monitoring Board which monitored the work at all five sites, led by the Chair, King Holmes and the

following members: Wasif Ali Panobinostat in vivo Khan, Edward Agbenyega, Grace Irimu, Mamadou Keita, Dih Sy Hien, Nik Zarifah Reed, Janet Wittes. We also appreciate the input into study design and analysis of Michele Coia, Michael J. Dallas, Steve Rivers, Donna Hyatt, and Florian Schödel from Merck and Co, and Kristen Lewis and Duncan Steele from PATH. Conflict of Interest Statement: Selleckchem Entinostat SOS received Merck funding as a member of the Advisory Board for Pediatric Vaccines and Vaccine New Products; MC was an employee of Merck when the study was conducted and owned equity in the company. No other conflicts of interest are declared. “
“In recent years, the World Health Organization has recommended two live, oral rotavirus vaccines for all infants worldwide [1]. Based on data from large, randomized placebo-controlled safety and efficacy trials conducted in Europe and Latin America for one [2] and

Europe and USA for the other [3], the vaccines were first recommended in 2006 for use in the Americas and Europe [4] and subsequently the recommendation was expanded to all countries worldwide in 2009 [1], after efficacy data from Asia and Africa became available [5], [6], [7], [8] and [9]. The urgency to have rotavirus second vaccines evaluated and

recommended for use in developing country populations is driven by the high global mortality of rotavirus disease, which is estimated to account for over 450,000 of the 1.3 million diarrhoeal deaths observed in young children every year [10]. Currently, very few developing countries with the highest rotavirus mortality rates have introduced rotavirus vaccines into their routine Expanded Program for Immunization (EPI) schedules. The two vaccines are fundamentally different with regard to their composition – one is a single-strain, attenuated human-based strain (Rotarix™, GSK Biologicals, Rixensart, Belgium) which is recommended as a 2-dose vaccine to be administered at EPI visit 1 and visit 2 and the other is a pentavalent bovine-human reassortant (RotaTeq®, Merck & Co, Whitehouse, New Jersey, USA), recommended as a 3-dose regimen to be administered with EPI visits 1, 2 and 3.