RESUMEN
BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).
Asunto(s)
Intususcepción/etiología , Vacunas contra Rotavirus/efectos adversos , Administración Oral , Estudios de Casos y Controles , Femenino , Humanos , Inmunización Secundaria/efectos adversos , Incidencia , India/epidemiología , Lactante , Intususcepción/epidemiología , Masculino , Vigilancia de Productos Comercializados , Riesgo , Infecciones por Rotavirus/prevención & control , Vacunación , Vacunas Atenuadas/efectos adversosRESUMEN
BACKGROUND: Night blindness and keratomalacia continue to be a problem among the tribal children and pregnant women residing in Jawadhi hills. OBJECTIVES: The objective of the study is to determine the prevalence and risk factors of Vitamin A deficiency (VAD) among children aged 1-8 years and women of reproductive age in a southern Indian tribal population. MATERIALS AND METHODS: A cross-sectional study was done among children aged 1-8 years and women aged 15-45 years residing in Jawadhi hills. Participants were randomly selected by cluster sampling. Their sociodemographic characteristics and frequency of consumption of Vitamin A rich food were collected through a structured questionnaire. Anthropometric measures and serum retinol levels, using high-performance liquid chromatography, were estimated for all participants. RESULTS: A total of 166 children and 211 women participated in this study. The prevalence of VAD among the children (1-8 years) was 10.2% (95% confidence interval [CI] 5.5%-14.9%) and among women of the reproductive age group was 3.8% (95% CI: 1.2%-6.4%). Dietary intake was not associated with serum retinol levels. Low educational status of the head of the household (adjusted odds ratio [aOR] = 8.9) and pregnancy (aOR = 11.6) was significantly associated with an increased risk of VAD among children and women, respectively. CONCLUSIONS: The prevalence of VAD among children is a moderate public health problem. Strategies must focus on pregnant women and children from families with more than four children.