Status:
COMPLETED
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
12+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1944 Patients enrolled
Trial Details
Trial ID
NCT01177657
Start Date
May 1 2008
End Date
May 1 2011
Last Update
November 19 2012
Active Locations (1)
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1
GSK Investigational Site
Belém, Pará, Brazil, 66 090 000