Effectiveness of Human Rotavirus Vaccine, Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants

Completed

• Conditions: Rotavirus Severe Gastroenteritis
• Interventions: Other: Collection of information; Procedure: Collection of stool samples

• Registration Number: NCT00655187
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study aims to evaluate the effectiveness of Rotarix™ vaccine in the general population in Singapore by monitoring the overall reduction in RV SGE and also by assessing the direct protection offered by the vaccine in hospitalised infants through a case-control study.

Detailed Description

This Protocol Posting has been updated following an amendment of the Protocol.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1270

Inclusion Criteria

Inclusion criteria for surveillance subjects

• A male or female child aged < 60 months at the time of admission (a child becomes ineligible on the day of its fifth birthday).
• Subject admitted with acute GE as an inpatient to the study site during the study period.
• Written informed consent obtained from the parent or guardian of the subject. Selection criteria for cases

Cases will be limited to those surveillance subjects:

• who are born after 1 November 2005 (date of availability of Rotarix™ vaccination in Singapore),
• who are aged at least 16 weeks at the time of hospital admission.
• whose stool samples are tested positive for RV. Selection criteria for controls

All controls must satisfy the following criteria at study entry:

• Admitted for acute disease with non-GE causes in the same hospital as the case , with the closest admission date to the cases.
• Aged at least 16 weeks at the time of hospital admission.
• Born within a range of ± 2 weeks from the date of birth of cases. In case there is no suitable match, then the range would be extended to ± 4 weeks.
• Written informed consent obtained from the subject's parents/guardians.

Exclusion Criteria

For enrolment of surveillance subjects

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

• The diagnoses at admission to the study site do not include acute GE.
• Children for whom stool samples are not available up to 48 hours after admission.
• The onset of GE is after 48 hours of admission to the hospital (i.e. nosocomial GE).
• Children with a history of chronic and genetic diseases. For selection of cases

In addition to the exclusion criteria for surveillance subjects, cases will not be selected if the following criterion applies:

• Subjects who had a previous episode of acute GE less than a week back i.e. recurrent GE episode.
• Subjects who have been already enrolled in the study.
• Subjects whose vaccination history could not be ascertained. For selection of controls

The following criteria should be checked at the time of study entry. If any apply, the controls must not be included in the study:

• Child who has symptoms of GE on the day of interview of his/her parent or guardian or had an episode of GE within 14 days prior to the day of interview.
• Child who has been already enrolled in the study as case or control.
• The onset of GE occurs after admission at the hospital.
• Child whose vaccination history could not be ascertained.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Collection of information	Controls
Group A	Collection of stool samples	Cases
Group A	Collection of information	Cases

Primary Outcome Measures

Name	Time	Method
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis (RV SGE) among children born after 1 November 2005 and aged at least 16 weeks.	At least one year
To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.	At least one year

Secondary Outcome Measures

Name	Time	Method
To determine the distributions of acute RV GE associated hospital admissions according to subject's age, gender and by month of year.	At least one year
To estimate the effectiveness of two doses of Rotarix™ vaccination in preventing hospitalisation for acute RV GE among children born after 1 November 2005 and aged at least 16 weeks.	At least one year
To estimate the prevalence of RV genotypes in acute RV GE associated hospital admission.	At least one year
To review the trend of acute RV GE and acute GE admissions over the entire study period.	At least one year

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore