Observational study to assess effectiveness of ROTATEQ® against acute gastroenteritis (AGE) due to rotavirus (regardless of type) and by type in China

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medicinal product name:
  ROTATEQ
• Study drug International non-proprietary name (INN) or common name:
  ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

  ROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

  ROTAVIRUS SEROTYPE G3 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

  ROTAVIRUS SEROTYPE G4 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS

  ROTAVIRUS SEROTYPE P1[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
• 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

• Short description of the study population:
  Study population from the V260-077 study: Children (infants not older than 12 weeks when ROTATEQ® was introduced in the catchment areas of the selected hospitals) with documented RV test results, age-eligible to be fully vaccinated with 3 doses of ROTATEQ®, and receiving treatment for AGE in hospitals.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Children with rotavirus gastroenteritis (regardless of type)
• Estimated number of subjects:
  7600

Study design details

• Study design:
  This is a secondary data collection study with Test-Negative Case-Control design. It will use structured data from the post-licensure study, V260-077. All RVGE cases (ELISA positive for RV test) identified from the V260-077 study will be defined as “cases”. No additional data are being collected.
• Main study objective:
  To assess the effectiveness of ROTATEQ® against all types of RVGE in children treated in the hospital for AGE.
• Setting:
  Study population from the V260-077 study: Children (infants not older than 12 weeks when ROTATEQ® was introduced in the catchment areas of the selected hospitals) with documented RV test results, age-eligible to be fully vaccinated with 3 doses of ROTATEQ®, and receiving treatment for AGE in hospitals. "Age-eligible" means children who have minimum age of 16 weeks at the time of AGE onset and maximum age of 12 weeks (upper age limit for dose 1) when ROTATEQ® was launched in the respective hospital catchment area.
• Comparators:
  All RV negative AGE cases (ELISA negative for RV test) identified from V260-077 study will be defined as “controls”.
• Outcomes:
  RV positive AGE (serotype-specific) receiving treatments in hospitals.
• Data analysis plan:
  For the primary objective, all RVGE cases (ELISA positive for RV test) identified from the V260-077 study will be defined as “cases”. All RV negative AGE cases (ELISA negative for RV test) identified from V260-077 study will be defined as “controls”. ; The study exposure of interest is ROTATEQ ® vaccination status. Odds ratios for ROTATEQ ® vaccination for case compared with test-negative controls will be estimated by a multivariate logistic regression, adjusting for potential confounders. ; The VE will be calculated as (1-odds ratio)×100%.