Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
NCT ID: NCT01177657
Last Updated: 2012-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1944 participants
OBSERVATIONAL
2008-05-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Gastroenteritis cohort
Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis
Stool sampling
Stool samples collected and checked for the presence of rotavirus
Hospital control cohort
Children hospitalized for non gastroenteritis causes
No interventions assigned to this group
Neighbourhood control cohort
Children without any symptoms of gastroenteritis or severe gastroenteritis
No interventions assigned to this group
Interventions
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Stool sampling
Stool samples collected and checked for the presence of rotavirus
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Weeks
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Belém, Pará, Brazil
Countries
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References
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Justino MC, Linhares AC, Lanzieri TM, Miranda Y, Mascarenhas JD, Abreu E, Guerra SF, Oliveira AS, da Silva VB, Sanchez N, Meyer N, Shafi F, Ortega-Barria E, Soriano-Gabarro M, Colindres RE. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belem, Brazil. Pediatr Infect Dis J. 2011 May;30(5):396-401. doi: 10.1097/INF.0b013e3182055cc2.
Other Identifiers
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111562
Identifier Type: -
Identifier Source: org_study_id