Post-marketing study to assess the risk of intussusception after immunization with GlaxoSmithKline (GSK) Biologicals’ oral live-attenuated human rotavirus vaccine in infants less than 1 year old in Latin America (212329)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medicinal product name:
  ROTARIX
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BH01) rota virus, live attenuated

  rota virus, live attenuated
• Medical condition to be studied:
  Intussusception

Population studied

• Short description of the study population:
  The source population for this study will be infants (6 weeks to less than (<) 1 year of age at the time of intussusception [IS] diagnosis) visiting or hospitalized in a recruiting hospital and who meet the study eligibility criteria at the time of entry into the study.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  1603

Study design details

• Study design:
  A hospital-based, observational, multicenter, prospective matched case-control study
• Main study objective:
  To evaluate post-authorization, the risk of definite IS following immunization with Rotarix PCV-free liquid vaccine in infants less than 1 year old in Latin America (LATAM).
• Setting:
  The study will include participants who will be divided into Cases and Controls. Cases include all infants hospitalized or visiting the hospital emergency room (ER) for definite IS at the participating hospitals during the study period and aged between 6 weeks and 1 year of age at the time of diagnosis of IS. Cases will be identified by periodic reviews of pediatric ward admission and ER logbook(s).; For each case, 6 controls hospitalized or visiting the hospital outpatient clinic or ER with no gastro-intestinal symptoms (including gastro-enteritis and IS) in the same participating hospital, on the same day as the case (±7 days), will be included after matching by age (±2 weeks) at index date.
• Outcomes:
  • Odds ratio of vaccine exposure to a first dose of RV vaccine between cases (IS) and controls; • Odds ratio of vaccine exposure to a second dose of RV vaccine between cases (IS) and controls; • Incidence risk ratio of definite IS comparing 3 risk windows after the first dose of RV vaccine to a control window.
• Data analysis plan:
  To estimate the vaccine exposure between cases and controls, a conditional logistic regression model will be used, the matched odds ratio of vaccine exposure between cases and controls, 95% CI, and p-values will be presented.; To compare the incidence of IS between the risk period and the control period, a Poisson regression stratified by subject will be used and the incidence rate ratio of IS (risk/control), 95% CI, and p-values will be presented.