Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
Completed
- Conditions
- Rotavirus Gastroenteritis
- Interventions
- Procedure: Stool sampling
- Registration Number
- NCT01177657
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
- Detailed Description
The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1944
Inclusion Criteria
For cases:
- A male or female child born after 6 March 2006 and at least 12 weeks of age.
- Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
- Onset of severe gastroenteritis ≤ 14 days prior to admission.
- Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
- Written informed consent obtained from the parent or guardian of the subject.
For controls:
- Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
- Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
- Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
- Written informed consent obtained from the parent or guardian of the child.
Exclusion Criteria
For cases:
- Subject has previously participated as case or control in this study.
- Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections).
For controls:
- For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian.
- Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
- Child has participated in the past as a case or control in this study.
- Child living in the same house as the case
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Gastroenteritis cohort Stool sampling Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis
- Primary Outcome Measures
Name Time Method Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children Average time frame: 12-24 months
- Secondary Outcome Measures
Name Time Method Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis Average time frame: 12-24 months Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children Average time frame: 12-24 months Occurrence of rotavirus serotypes among children Average time frame: 36 months
Trial Locations
- Locations (1)
GSK Investigational Site
🇧🇷Belem, Pará, Brazil