In 2005, the Strategic Advisory Group of Experts (SAGE), an advisory committee to the WHO, endorsed the use of RV vaccines for the Americas and LEE011 Europe, where the vaccines had been evaluated, but noted the lack of efficacy data in Asia and Africa [5]. Given this, SAGE recommended that efficacy for RV vaccines should be studied in Asia and Africa, corroborating the view of the RV Accelerated Development and Introduction Program (ADIP) supported by the Global Alliance for Vaccines and Immunization (GAVI). Subsequently, in 2009 the efficacy data for the monovalent

RV vaccine, Rotarix™ (GlaxoSmithKline Biologicals, Rixensart, Belgium), in South Africa and Malawi as well as early introduction experiences from the Americas motivated SAGE to endorse a universal RV vaccination recommendation for that vaccine in all regions of the world to WHO [6]. In response to the initial call for efficacy trials by SAGE, it was deemed important also to document the efficacy of the oral pentavalent RV vaccine (PRV), RotaTeq™ (Merck & Co., Inc., Whitehouse Station, NJ, USA) for prevention of severe RVGE in young children in developing countries. Accordingly, from 2007 until 2009, two large-scale, multi-site, randomized, placebo-controlled field trials were carried out, one in Asia (Vietnam and Bangladesh) Selleckchem GSK1120212 [7] and the other in sub-Saharan Africa

(Mali, Kenya and Ghana) [8], to assess the efficacy of PRV in preventing severe RVGE in infants and toddlers. Herein we describe the results of the sub-analysis of the children enrolled in the efficacy trial carried out in Mali, West Africa. The overall methodology for the multi-center study in sub-Saharan Africa, including Mali, has been described by Armah et al. [8]. Infants with no symptoms of ongoing gastroenteritis were randomly allocated 1:1 to receive 3 doses of PRV or placebo according to the Expanded Program on Immunization (EPI) schedule at approximately 6, 10, and 14 weeks Cell press of age. Breastfeeding was not discouraged, withheld or delayed

during vaccination. The study was double-blinded (with sponsor blinding). Symptom data were solicited from parents upon presentation to health care facilities and clinical data were collected prospectively by clinicians. Stool samples were analyzed by a RV-specific enzyme immunoassay (EIA) to detect rotavirus antigen [9]. Rotavirus-positive EIA samples were further characterized by RT-PCR to determine the G/P genotypes of the RV strains [10]. The primary endpoint was severe RVGE (Vesikari score ≥11), occurring from 14 days following the third dose through the end of the study. Other EPI vaccines concomitantly administered included oral poliovirus vaccine (OPV) and the pentavalent vaccine containing diphtheria and tetanus toxoids, whole cell pertussis, Haemophilus influenzae type b conjugate and hepatitis B as per the national schedule in Mali.