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

NCT ID: NCT01978223

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Infections, Rotavirus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Stool sample collection

Intervention Type: 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.

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.

Stool sample collection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 12 Weeks
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

116494

Identifier Type: -

Identifier Source: org_study_id