Effectiveness of RotarixTM Vaccine in Children Aged Between 12 Weeks to < 5 Years, Hospitalised for Severe Gastroenteritis

This study is not yet open for participant recruitment.
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01978223
First received: October 31, 2013
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This study aims to estimate the effectiveness of Rotarix™ vaccine against Rotavirus severe gastroenteritis (RV SGE) among hospitalised children aged between 12 weeks and < 5 years, in Venezuela and to assess the current disease burden after introduction of the vaccine.


Condition Intervention
Infections, Rotavirus
Procedure: Stool 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 RotarixTM Against Rotavirus Severe Gastroenteritis Among Hospitalised Children Aged 12 Weeks to < 5 Years, in Venezuela

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Full vaccination status of Rotarix™ (2 doses) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls). [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Full/partial vaccination status (at least one dose of Rotarix™) with the vaccine administered at least 2 weeks before hospitalisation in RV-positive SGE children (cases) compared to RV-negative SGE children (controls). [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of specific RV genotype among the enrolled RV SGE children with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine is administered at least 2 weeks before hospitalisation). [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of RV SGE in children by age at hospitalisation with full/partial vaccination status (at least one dose of Rotarix™ with the vaccine administered at least 2 weeks before hospitalisation). [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale. [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children. [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE. [ Time Frame: At hospital admission/ ED stay or during the first 48 hours of hospitalisation. ] [ Designated as safety issue: No ]
  • Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year. [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]
  • Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE. [ Time Frame: During hospitalisation and after discharge (approximately 12 months from study initiation). ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Stool sample


Estimated Enrollment: 1500
Study Start Date: May 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ED stay and whose stool samples test positive for RV by enzyme linked immunosorbent assay (ELISA) at a GSK designated laboratory.
Procedure: Stool sample collection
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
Controls
Children hospitalised for SGE, aged 12 weeks to < 5 years at the time of hospital admission/ ED stay, whose stool samples test negative for RV by enzyme linked immunosorbent assay at a GSK designated laboratory and who will be matched to the cases by date of birth and the hospital of admission/ ED stay.
Procedure: Stool sample collection
Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.

Detailed Description:

The data generated in this study will be useful for public health officers and policy makers in confirming the country-wide public health benefit of Rotarix™.

No vaccine will be administered during this study.

  Eligibility

Ages Eligible for Study:   12 Weeks to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged 12 weeks to < 5 years, hospitalised for SGE in the study hospitals.

Criteria

Inclusion Criteria:

For SGE subjects:

  • A male or female child aged 12 weeks to < 5 years at the time of hospital admission/ ED stay. The subject becomes ineligible on the fifth birthday.
  • Subject admitted to (or who will have an ED stay at) the study hospital(s) for SGE during the study period.
  • Onset of SGE ≤ 14 days prior to admission/ ED stay.
  • Written/thumb printed informed consent obtained from the parent(s)/legally acceptable representative(s) (LAR (s)) of the subject.

For Cases:

• Laboratory confirmed (i.e. by ELISA) RV-positive stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.

For Controls:

  • Subject admitted to (or who will have an ED stay at) the same study hospital(s) for SGE as that of the case during the study period.
  • Laboratory confirmed (i.e. by ELISA) RV-negative stool sample collected at hospital admission/ ED stay or during the first 48 hours of hospitalisation.
  • Subjects born within ± 2 weeks from the date of birth of the case.

Exclusion Criteria:

For SGE subjects:

  • Child in care.
  • Hospitalisation is unrelated to GE.
  • Onset of SGE > 48 hours after admission to (or ED stay at) the hospital.
  • Subject has digestive tube anomalies, chronic gastrointestinal disease or uncorrected congenital abnormalities.
  • Subject with immunodeficiency.
  • Subjects who live out of the federative entity where hospital(s) are located.

For Controls:

• Subject has previously participated as case in this study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01978223

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01978223     History of Changes
Other Study ID Numbers: 116494
Study First Received: October 31, 2013
Last Updated: March 6, 2014
Health Authority: Venezuela: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Children
Vaccine effectiveness
Hospitalised
Venezuela
Rotavirus Severe Gastroenteritis
Case-control
Rotarix™

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014