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

NCT00655187 | Completed

• 1 other identifier: 110467
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotavirus Severe Gastroenteritis

Outcome Measures

Primary Outcomes (2)

• To estimate the proportion of acute RV GE hospitalisations in children < 5 years of age.

  At least one year

• 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

Secondary Outcomes (4)

• 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 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 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

Study Arms (2)

Group A

Cases

Other: Collection of information; Procedure: Collection of stool samples

Group B

Controls

Other: Collection of information

Interventions

Collection of information OTHER

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

Group A; Group B

Collection of stool samples PROCEDURE

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

Group A

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children less than 5 years of age, hospitalised with acute GE, living in Singapore served by the hospital participating in the study (KK Hospital) and whose parents/ guardians are willing to provide informed consent, will be considered as cases. Cases will be limited to those subjects who are born after 1 November 2005, aged at least 16 weeks and whose stool samples have been tested positive for rotavirus (RV). For each case, two controls hospitalised for acute disease with non-GE causes in the same hospital during the same period, will be included in the study after matching them by date of birth.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Singapore, 229899, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 9, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

SG (1)