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

GlaxoSmithKline (GSK)

Status: Withdrawn

Conditions: Infections, Rotavirus

Treatments: Procedure: Stool sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01978223

116494

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 weeks to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

Cases

Description:

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.

Treatment:

Procedure: Stool sample collection

Controls

Description:

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.

Treatment:

Procedure: Stool sample collection