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. (see Contacts and Locations)
Verified April 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01978223
First received: October 31, 2013
Last updated: April 17, 2014
Last verified: April 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: December 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 17, 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
Digestive System Diseases
Gastrointestinal Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014