title: Effectiveness of vaccination with the pentavalent rotavirus vaccine in Nicaragua as determined using the screening method.
abstract: The screening method is a surveillance tool to evaluate vaccine effectiveness (VE) using coverage data on cases and available administrative estimates of vaccine coverage in the population. The aim of this analysis was to evaluate the utility and limitations of using the screening methodology to estimate VE, particularly in a developing world country with a high coverage rate, and to compare it with the VE estimates from 2 case-control studies. Using data from 2008, the screening method employed in this study estimated that VE for 3 doses of RV5 among children<12 mo of age to prevent wild-type severe disease, resulting in hospitalization or emergency department visits, was 92% (95% confidence interval [CI]: 78-100%). Additional sensitivity analysis demonstrated that the point estimates of VE against severe disease ranged from 72% (95% CI: 62-83%) to 92% (95% CI: 78-100%); this range of VE estimates, although wide, is relatively consistent with results reported from 2 case-control studies in Nicaragua for the same time period. When the infrastructure is in place to collect reasonably robust case data, the use of the screening method to estimate VE is possible in the developing world setting. Cases of severe wild-type rotavirus gastroenteritis were obtained through an observational, hospital-based, prospective, surveillance program to assess rotavirus acute gastroenteritis. The proportion of cases vaccinated was estimated using the child's vaccination card or health record. The proportion of the population vaccinated was estimated using administrative population-based vaccination coverage estimates provided by the Nicaraguan Ministry of Health.
authors.affiliation: Merck Research Laboratories; North Wales, PA USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Cardellino
authors.forename: Shazia
authors.initials: S
authors.lastname: Khawaja
authors.forename: Edmundo
authors.initials: E
authors.lastname: Sánchez Cruz
authors.forename: T Christopher
authors.initials: TC
authors.lastname: Mast
mesh_terms: D016022:Case-Control Studies; D002675:Child, Preschool; D003906:Developing Countries; D005759:Gastroenteritis / Q000517:prevention & control* / Q000628:therapy / Q000821:virology; D006801:Humans; D007223:Infant; D009527:Nicaragua; D012401:Rotavirus / Q000276:immunology; D012400:Rotavirus Infections / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines / Q000627:therapeutic use*; D016896:Treatment Outcome; D014611:Vaccination; D064166:Vaccine Potency; D014613:Vaccines, Attenuated / Q000627:therapeutic use
chemical_list: C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: RV5; pentavalent rotavirus vaccine; rotavirus; screening method; vaccine effectiveness