Victor Nigel Cunliffe drafted the manuscript

Victor. Nigel Cunliffe drafted the manuscript with scientific input from all authors. All authors approved the final version of the manuscript. Conflict of interest statement: N.A. Cunliffe has received research grant support and honoraria from GlaxoSmithKline Biologicals and Sanofi Pasteur MSD. A. Bouckenooghe is an employee of Sanofi Pasteur and a former employee of GSK Biologicals. “
“Rotavirus is a leading cause of under-5 childhood mortality, with an estimated 232,000 (50%) of 453,000 annual deaths attributed to this virus occurring in sub-Saharan Africa [1]. In 2009, the World Health Organization (WHO) recommended

that infant immunization with human rotavirus vaccine (HRV) should be introduced in all countries and particularly where greater than 10% of under-5 mortality is attributed to diarrhea [2]. This revised recommendation was supported in part by clinical trials from Africa in which the efficacy of HRV during infancy was established [3] and [4]. Although the efficacy of the rotavirus vaccines against severe rotavirus diarrhea in the first year of life, was lower in African studies

(61–65%) [3] and [4], compared to those from more industrialized settings (84–100%) [5], [6], [7] and [8], the burden of disease prevented in African studies (5.0 per 100 infant-years) exceeded that prevented Bioactive Compound Library price in studies from Europe [6], Latin America [9], and middle-income countries in Asia [10]. Multi-country efficacy studies of Rotarix™ (GlaxoSmithKline [GSK] Biologicals) and RotaTeq™ (Merck & Co., Inc.), in Africa, however, Olopatadine have also demonstrated between-country differences in vaccine efficacy against severe

rotavirus gastroenteritis (S-RVGE) [3] and [4]. While the efficacy of Rotarix against S-RVGE was greater in South African (76.9%) compared to Malawian (49.4%) infants, the attributable reduction of S-RVGE was two-fold greater among Malawian infants [3]. Furthermore, persistence of HRV protection against S-RVGE during the second year of life and/or two consecutive rotavirus seasons has predominantly been established in industrialized settings [7], [8], [9] and [10], whereas the sustainability of protection against S-RVGE remains to be established in African settings. Post-introduction effectiveness studies in some Latin American countries have indicated that there is a decrease in protection during the second year of life with Rotarix and RotaTeq [11] and [12]. In addition, vaccine efficacy point-estimates against S-RVGE were lower in the second year of life (19.6%) compared to that in the first year of life (64%) with RotaTeq in Africa [4]. Based on the differences in rotavirus vaccine-efficacy and epidemiology of infection between South African and Malawian infants during infancy in the Phase 3 Rotarix trial [3], we now report on country-specific data on the extended efficacy evaluation and immunogenicity of HRV.

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