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

Purpose

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.

Condition	Intervention
Rotavirus Gastroenteritis	Procedure: Stool sampling

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 [ Time Frame: Average time frame: 12-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Average time frame: 12-24 months ] [ Designated as safety issue: No ]
Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis [ Time Frame: Average time frame: 12-24 months ] [ Designated as safety issue: No ]
Occurrence of rotavirus serotypes among children [ Time Frame: Average time frame: 36 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Stool sample

Enrollment:	1944
Study Start Date:	May 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	12 Weeks and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177657

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01177657 History of Changes
Other Study ID Numbers:	111562
Study First Received:	August 5, 2010
Last Updated:	November 15, 2012
Health Authority:	Brazil: ANVISA

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013