Effectiveness of ROTATEQ® when administered with intervals greater than 10 weeks between doses in Chinese children: an observational study of V260-077 study participants with longer dosing interval (V260-080)

Study type

• Study topic:
  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

• 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

• Short description of the study population:
  The study population includes children from the enrollment population of the V260-077 study, with documented Rotavirus (RV) test results and who received the ROTATEQ vaccine with at least one dosing interval greater than 10 weeks. The estimated number of participants will include the number of children who were vaccinated with intervals > 10 weeks plus the non-vaccinated children.;
• 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)
• Estimated number of subjects:
  3800

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. No additional data are being collected in this study.
• Main study objective:
  The main objective of this study is to assess the vaccine effectiveness of ROTATEQ® against all types of RVGE when the vaccine is administered in children with at least one dosing interval greater than 10 weeks between doses 1 and 2 and/or 2 and 3.
• Setting:
  The study population includes children from the enrollment population of the V260-077 study, with documented Rotavirus (RV) test results and who received the ROTATEQ vaccine with at least one dosing interval greater than 10 weeks and excludes children with incomplete ROTATEQ® schedule and children who had received ROTATEQ® within 14 days before the onset of AGE.
• Outcomes:
  The study outcome is the eligible RV positive/negative Acute gastroenteritis (AGE) in children receiving treatment in hospitals from the V260-077 study. In V260-077 study, AGE is defined as 3 or more watery or looser than normal stools within 24 hour period and/or forceful vomiting. ; For the primary objective, all RVGE cases who did not meet the exclusion criteria, identified from the V260-077 study will be defined as “cases”. ; Children are considered a “control” for all objectives if they have RV negative AGE, receiving treatments in hospitals from V260-077 enrollment; dataset.
• Data analysis plan:
  Vaccine effectiveness (VE) will be calculated by comparing the odds ratio of “vaccination with intervals >10 weeks versus unvaccinated” among cases (RV positives) compared to controls (RV negatives), using multivariate logistic regression adjusted for potential confounders. ; The VE will be calculated as (1-odds ratio)×100%.