Post-marketing study to assess serotype-specific effectiveness of Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell) (ROTATEQ®) in China (V260-077)

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:
  • Paediatric Population (< 18 years)

    • 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.