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

NCT01978223 | Withdrawn

• 1 other identifier: 116494
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infections, Rotavirus

Keywords

Rotarix™; Case-control; Venezuela; Vaccine effectiveness; Rotavirus Severe Gastroenteritis; Children; Hospitalised

Outcome Measures

Primary Outcomes (1)

• 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).

  During hospitalisation and after discharge (approximately 12 months from study initiation).

Secondary Outcomes (8)

• 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).

  During hospitalisation and after discharge (approximately 12 months from study initiation).

• 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).

  During hospitalisation and after discharge (approximately 12 months from study initiation).

• 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).

  During hospitalisation and after discharge (approximately 12 months from study initiation).

• Occurrence of RV SGE in children by severity with assessment of severity of RV SGE cases by the Vesikari scale.

  During hospitalisation and after discharge (approximately 12 months from study initiation).

• Occurrence of SGE [≤14 days prior to admission/ Emergency Department (ED) stay] among all hospitalised children.

  During hospitalisation and after discharge (approximately 12 months from study initiation).

Study Arms (2)

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

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

Interventions

Stool sample collection PROCEDURE

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.

Cases; Controls

Eligibility Criteria

• Age: 12 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2015-03