Effectiveness of rotavirus vaccination: Generic study protocols for retrospective case control and cohort studies based on computerised databases

technical guidance protocol

In Europe, routine rotavirus vaccination of infants at the national level has been introduced with one or two vaccine brands in Finland, Austria, Luxembourg and Belgium within well-baby clinics or administered by general practitioners and paediatricians. When introducing a new vaccine, it is crucial to conduct studies evaluating the vaccination’s impact and effectiveness in order to decide on recommendations for its future use. ECDC has produced three generic protocols: a protocol for developing cohort studies to assess the effectiveness of the rotavirus vaccination in EU Members States; a protocol proposing prospective case control study designs to estimate rotavirus vaccine effectiveness; and a protocol for developing studies to assess the impact of rotavirus vaccination EU Member States.

Executive summary

Rotavirus is the most common cause of gastroenteritis in children worldwide. It has been estimated that by the age of five years, nearly every child in the world has been infected with rotavirus at least once.

In April 2009, the World Health Organization Strategic Advisory Group of Experts (SAGE) recommended rotavirus vaccine for all children. In Europe, routine rotavirus vaccination of infants at the national level has been introduced in Austria, Belgium, Finland and Luxembourg.  When introducing a new vaccine, it is crucial to conduct studies evaluating the vaccination’s impact and effectiveness in order to decide on recommendations for its future use. To this end, ECDC has produced three generic protocols: a protocol for developing cohort studies to assess the effectiveness of the rotavirus vaccination in EU Members States; a protocol proposing prospective case control study designs to estimate rotavirus vaccine effectiveness; and a protocol for developing studies to assess the impact of rotavirus vaccination EU Member States.

All updates on rotavirus vaccination

Publication

Expert opinion on rotavirus vaccination in infancy

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Impact of rotavirus vaccination

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Data

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