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

NCT ID: NCT00655187

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Rotavirus Severe Gastroenteritis

Study Design

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

Study Groups

Group A

Cases

Collection of information

Intervention Type: OTHER

Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.

Collection of stool samples

Intervention Type: PROCEDURE

Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.

Group B

Controls

Collection of information

Intervention Type: OTHER

Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.

Interventions

Collection of information

Information regarding demographic characteristics, medical history, previous participation in rotavirus clinical trials and vaccination history will be collected.

Intervention Type: OTHER

Collection of stool samples

Stools samples will be collected during hospitalisation for RV testing and genotyping of RV positive samples.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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

Locations

GSK Investigational Site

Singapore, , Singapore

Countries

Singapore

Other Identifiers

110467

Identifier Type: -

Identifier Source: org_study_id