Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil

NCT01177657 | Completed

• 1 other identifier: 111562
• Study Type: observational
• Target: 1,944
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotavirus Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis

  Average time frame: 12-24 months

• Occurrence of rotavirus serotypes among children

  Average time frame: 36 months

Study Arms (3)

Gastroenteritis cohort

Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis

Procedure: Stool sampling

Hospital control cohort

Children hospitalized for non gastroenteritis causes

Neighbourhood control cohort

Children without any symptoms of gastroenteritis or severe gastroenteritis

Interventions

Stool sampling PROCEDURE

Stool samples collected and checked for the presence of rotavirus

Gastroenteritis cohort

Eligibility Criteria

• Age: 12 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gastroenteritis Cohort: Cases will include children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis the study clinics/hospitals, during the designated study period, Hospital control cohort: Children hospitalized for non gastroenteritis causes, Neighbourhood control cohort: Children without any symptoms of gastroenteritis or severe gastroenteritis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Belém, Pará, 66 090 000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 21150692 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 9, 2010
• Study Start: May 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

BR (1)