Background Rotavirus is the most common cause of severe dehydrating gastroenteritis in developing countries. Safe, effective, and affordable rotavirus vaccines are needed for developing countries. Methods In a double-blind placebo controlled multicentre trial, 6799 infants aged 6 to 7 weeks were randomised to receive three doses of an oral human-bovine natural reassortant vaccine (116E) or placebo at ages 6, 10, and 14 weeks. Primary outcome was severe (≥11 on the Vesikari scale) rotavirus gastroenteritis. Efficacy outcomes and adverse events were ascertained through active surveillance. Findings At analyses, the median age was 17·2 months; over 96% subjects received all three doses of the vaccine/placebo and ~1% were lost to follow up. 4532 and 2267 subjects were randomly assigned to receive vaccine and placebo, respectively. The per protocol analyses included 4354 subjects in the vaccine and 2187 subjects in the placebo group. 71 events of severe rotavirus gastroenteritis were reported in 4752 person years among the vaccinees compared to 76 events in 2360 person years in the placebo recipients; vaccine efficacy against severe rotavirus gastroenteritis was 53·6% (95% CI 35·0–66·9; P<0·001) and 56·4% (95% CI 36·6–70·1; P <0·001) in the first year of life. The number of infants needed to be immunized to prevent one severe rotavirus gastroenteritis episode was 55 (95% CI 37–97). The incidence of severe rotavirus gastroenteritis/100 person years was 1·5 in vaccine and 3·2 in placebo group and an incidence rate ratio of 0·46 (95% CI 0·33–0·65). The absolute rate reduction for severe rotavirus gastroenteritis was 1·7 (95% CI 2·5–0·9). Efficacy against severe gastroenteritis of any aetiology was 18·6% (95% CI 1·9–32·3); it was 24·1% (95% CI 5·8–38·7) in the first year of life. The prevalence of immediate, solicited, and serious adverse events were similar in both groups. There were six cases of intussusception amongst 4532 vaccinees and two amongst 2267 placebo recipients (P=0·73). All intussusception cases occurred after the third dose. Among vaccine and placebo recipients, the minimum interval between dosing and intussusception was 112 and 36 days, respectively. Interpretation The monovalent human-bovine (116E) rotavirus vaccine is effective and well-tolerated in Indian infants.

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HighlightsPentavalent reassortant rotavirus vaccine was tested for efficacy in infants.The vaccine (BRV-PV) showed excellent tolerability and a good safety profile.Primary analysis efficacy was 36% against SRVGE and up to 60.5% against VSRVGE.The efficacy through 2 years of age was 39.5% (SRVGE) and 54.7% (VSRVGE).The intent to treat analyses confirmed all the per protocol analyses.

The trial is registered with Clinical Trial Registry-India (# CTRI/2010/091/000102) and Clinicaltrials.gov (# NCT01305109).

Abstract.Pneumonia is the leading cause of death in children. The objectives were to evaluate the microbiological agents linked with hypoxemia in hospitalized children with pneumonia from developing countries, to identify predictors of hypoxemia, and to characterize factors associated with in-hospital mortality. A multicenter, observational study was conducted in five hospitals, from India (Lucknow, Vadu), Madagascar (Antananarivo), Mali (Bamako), and Paraguay (San Lorenzo). Children aged 2–60 months with radiologically confirmed pneumonia were enrolled prospectively. Respiratory and whole blood specimens were collected, identifying viruses and bacteria by real-time multiplex polymerase chain reaction (PCR). Microbiological agents linked with hypoxemia at admission (oxygen saturation < 90%) were analyzed by multivariate logistic regression, and factors associated with 14-day in-hospital mortality were assessed by bivariate Cox regression. Overall, 405 pneumonia cases (3,338 hospitalization days) were analyzed; 13 patients died within 14 days of hospitalization. Hypoxemia prevalence was 17.3%. Detection of human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) in respiratory samples was independently associated with increased risk of hypoxemia (adjusted odds ratio [aOR] = 2.4, 95% confidence interval [95% CI] = 1.0–5.8 and aOR = 2.5, 95% CI = 1.1–5.3, respectively). Lower chest indrawing and cyanosis were predictive of hypoxemia (positive likelihood ratios = 2.3 and 2.4, respectively). Predictors of death were Streptococcus pneumoniae detection by blood PCR (crude hazard ratio [cHR] = 4.6, 95% CI = 1.5–14.0), procalcitonin ≥ 50 ng/mL (cHR = 22.4, 95% CI = 7.3–68.5) and hypoxemia (cHR = 4.8, 95% CI = 1.6–14.4). These findings were consistent on bivariate analysis. hMPV and RSV in respiratory samples were linked with hypoxemia, and S. pneumoniae in blood was associated with increased risk of death among hospitalized children with pneumonia in developing countries.

In this licensure study, 23 cases of intussusception were identified through an active surveillance system, but there was no temporal association with rotavirus vaccination. The use of active surveillance with broad criteria intended for ensuring safety of children participating in a trial, identified several transient intussusceptions that were of doubtful clinical significance.

Background Globally, community health workers (CHWs) are integral contributors to many health systems. In India, Accredited Social Health Activists (ASHAs) have been deployed since 2005. Engaged in multiple health care activities, they are a key link between the health system and population. ASHAs are expected to participate in new health programmes prompting interest in their current workload from the perspective of the health system, community and their family. Methods This mixed-methods design study was conducted in rural and tribal Primary Health Centers (PHCs), in Pune district, Western Maharashtra, India. All ASHAs affiliated with these PHCs were invited to participate in the quantitative study, those agreeing to contribute in-depth interviews (IDI) were enrolled in an additional qualitative study. Key informants’ interviews were conducted with the Auxiliary Nurse Midwife (ANM), Block Facilitators (BFF) and Medical Officers (MO) of the same PHCs. Quantitative data were analysed using descriptive statistics. Qualitative data were analysed thematically. Results We recruited 67 ASHAs from the two PHCs. ASHAs worked up to 20 h/week in their village of residence, serving populations of approximately 800–1200, embracing an increasing range of activities, despite a workload that contributed to feelings of being rushed and tiredness. They juggled household work, other paid jobs and their ASHA activities. Practical problems with travel added to time involved, especially in tribal areas where transport is lacking. Their sense of benefiting the community coupled with respect and recognition gained in village brought happiness and job satisfaction. They were willing to take on new tasks. ASHAs perceived themselves as ‘voluntary community health workers’ rather than as ‘health activists”. Conclusions ASHAs were struggling to balance their significant ASHA work and domestic tasks. They were proud of their role as CHWs and willing to take on new activities. Strategies to recruit, train, skills enhancement, incentivise, and retain ASHAs, need to be prioritised. Evolving attitudes to the advantages/disadvantages of current voluntary status and role of ASHAs need to be understood and addressed if ASHAs are to be remain a key component in achieving universal health coverage in India.

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