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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Rotavirus Gastroenteritis

Treatments

Procedure: Stool sampling

Study type

Observational

Funder types

Industry

Identifiers

NCT01177657

111562

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,944 patients

Sex

All

Ages

12+ weeks old

Volunteers

No Healthy Volunteers

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