Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Study drug and medical condition

Name of medicine

ROTATEQ

Anatomical Therapeutic Chemical (ATC) code

(J07BH02) rota virus, pentavalent, live, reassorted
rota virus, pentavalent, live, reassorted

Medical condition to be studied

Gastroenteritis rotavirus
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)

Estimated number of subjects

7600
Study design details

Main study objective

The objective of this non-interventional study is to assess the serotype-specific effectiveness of ROTATEQ® after large scale use in China

Outcomes

Rotavirus acute gastroenteritis (RVGE) positive for at least one of the serotypes G2/G3/G4 in children who received treatment in the hospital. Rotavirus acute gastroenteritis (RVGE) positive for at least one of the serotypes G1/G2/G3/G4/G9 in children who received treatment in the hospital.

Data analysis plan

A descriptive analysis of the distribution of values observed for each variable will be provided. Search for outliers, logical errors and necessary corrections will be made.
The following indicators will be computed (for each hospital and by year, if relevant): Number of acute gastroenteritis (AGE) cases in children age-eligible to be vaccinated with ROTATEQ®, Number of rotavirus acute gastroenteritis (RVGE) cases in children age-eligible to be vaccinated with ROTATEQ®, and Number of G1, G2, G3, G4, G9 RVGE cases in children age-eligible to be vaccinated with ROTATEQ®.
Vaccine effectiveness (VE) will be estimated once the sample size is sufficient to reach 80% statistical power. VE will be computed as: 1- odds ratio (OR), where OR is the ratio of the likelihood of ROTATEQ® vaccination among RVGE to the likelihood of vaccination among RV negative AGE.