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

Infections, Rotavirus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01978223
• Other study ID #: 116494
• Status: Withdrawn
• Phase: N/A
• First received: October 31, 2013
• Last updated: March 6, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Weeks to 5 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	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).	No
Secondary	Occurrence of RV SGE hospital admissions/ ED stays among children hospitalised at the study hospital(s) for SGE.		At hospital admission/ ED stay or during the first 48 hours of hospitalisation.	No
Secondary	Occurrence of RV SGE admissions/ ED stays by age of the child (at hospitalisation) and month of year.		During hospitalisation and after discharge (approximately 12 months from study initiation).	No
Secondary	Occurrence of RV genotypes among children admitted to (or who have had an ED stay at) the study hospital(s) for SGE.		During hospitalisation and after discharge (approximately 12 months from study initiation).	No