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

Rotavirus Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177657
• Other study ID #: 111562
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: November 15, 2012
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1944
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Weeks and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Rotavirus Gastroenteritis

Intervention

Procedure:
• Stool sampling
Stool samples collected and checked for the presence of rotavirus

Locations

Country	Name	City	State
Brazil	GSK Investigational Site	Belem	Pará

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

References & 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-Gabarró M, Colindres RE. Effectiveness of the monovalent G1P[8] human rotavirus vaccine against hospitalization for severe G2P[4] rotavirus gastroenteritis in Belém, Brazil. Pediatr Infect Dis J. 2011 May;30(5):396-401. doi: 10.1097/INF.0b013e3182055cc2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis		Average time frame: 12-24 months	No
Secondary	Occurrence of rotavirus serotypes among children		Average time frame: 36 months	No