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

Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis
• Intervention / Treatment: Procedure: Stool sampling

Detailed Description

The study will be comprised of two parts: Case-control study and Rotavirus strain surveillance.

• Study Type: Observational
• Enrollment (Actual): 1944

Contacts and Locations

Study Locations

• Brazil
  • Pará
    • Belem, Pará, Brazil, 66 090 000
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastroenteritis cohort; Children born after 6 March 2006, at least 12 weeks of age and hospitalized for rotavirus severe gastroenteritis	Procedure: Stool sampling; Stool samples collected and checked for the presence of rotavirus
Hospital control cohort; Children hospitalized for non gastroenteritis causes
Neighbourhood control cohort; Children without any symptoms of gastroenteritis or severe gastroenteritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 5, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2012
• Last Update Submitted That Met QC Criteria: November 15, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 111562