Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children - Full Text View

Purpose

The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.

Condition	Intervention
Rotavirus Vaccines	Procedure: Sample collection

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Case-control Study to Evaluate the Vaccine Effectiveness of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix™) Against Community-acquired Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 October 2006, in Belgium

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:

Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children [ Time Frame: More than 14 days after receipt of vaccine ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children [ Time Frame: More than 14 days after receipt of vaccine ] [ Designated as safety issue: No ]
Occurrence of PCR-confirmed RV SGE in children who received at least one dose of Rotarix or Rotateq in unvaccinated children [ Time Frame: More than 14 days after receipt of vaccine ] [ Designated as safety issue: No ]
Occurrence of SGE due to RV among children born after 01 October 2006, at least 14 weeks of age and admitted to hospital [ Time Frame: Average time frame: 1 year from the date of subject enrolment ] [ Designated as safety issue: No ]
Occurrence of co-infections with other organisms among children born after 1 October 2006, at least 14 weeks of age and hospitalized with PCR-confirmed RV SGE [ Time Frame: Average time frame: 1 year from the date of subject enrolment ] [ Designated as safety issue: No ]
Occurrence of PCR-confirmed RV SGE by age and month of year, among children born after 01 October 2006, at least 14 weeks of age and admitted to the hospital [ Time Frame: Average time frame: 1 year from the date of subject enrolment ] [ Designated as safety issue: No ]
Occurrence of RV serotypes among hospitalized PCR-confirmed RV SGE children born after 01 October 2006 and at least 14 weeks of age [ Time Frame: Average time frame: 1 year from the date of subject enrolment ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Stool samples

Enrollment:	643
Study Start Date:	February 2008
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 Cases	Procedure: Sample collection Stool sample
Group 2 Controls

Eligibility

Ages Eligible for Study:	14 Weeks to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The confirmed cases are children born after 01 October 2006, at least 14 weeks of age, hospitalized for SGE during the designated study period and whose stool samples have been tested positive for RV by polymerase chain reaction (PCR). The controls are those children hospitalised or visiting the hospital outpatient clinic for non-GE causes at the study hospitals during the same time-period as the case and will be included after matching by age.

Criteria

Inclusion Criteria:

For confirmed cases:

A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of hospital admission.
Child admitted at the study hospital for SGE during the study period.
Onset of SGE ≤ 14 days prior to admission.
Written informed consent obtained and signed from the parent or guardian of the child.
Stool samples collected during the first 48 hours of hospitalisation and then tested positive for RV by PCR.

For controls:

A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of the hospital admission or visit to the hospital outpatient clinic.
Hospitalised or visiting the hospital outpatient clinic for non-GE causes at the same hospital during the same time-period, as the probable case.
Born within ±2 weeks from the date of birth of the case. If the list of children born within ±2 weeks is exhausted, then the range will be extended to ±4 weeks. In case a suitable control is not found even then, the range will be extended to ±6 weeks.
Written informed consent obtained and signed from the parent or guardian of the child.

Exclusion Criteria:

For cases:

Child has previously participated as a case or a control in this study, either in the same hospital or in another study hospital.
Onset of SGE >48 hours after admission to the hospital (nosocomial infections).
Child with a condition where rotavirus vaccination would be contraindicated.

For controls:

Child has participated in the past as a case or control in this study, either in the same hospital or in another study hospital.
Child who has symptoms of GE/ SGE during current hospital stay/ visit to the hospital outpatient clinic or on the day of interview of his/her parent or guardian.
Child with a condition where rotavirus vaccination would be contraindicated.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177826

Locations

Belgium
GSK Investigational Site
Eeklo, Belgium, 9900
GSK Investigational Site
Genk, Belgium, 3600

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01177826 History of Changes
Other Study ID Numbers:	111426
Study First Received:	August 6, 2010
Last Updated:	May 2, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by GlaxoSmithKline:

Hospitalized
Rotavirus
Children
effectiveness
Gastroenteritis

Additional relevant MeSH terms:

Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013