Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children

Case-control Study to Evaluate the Vaccine Effectiveness of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix™) Against Community-acquired Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 October 2006, in Belgium

The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.

Study Overview

• Status: Completed
• Conditions: Infections, Rotavirus; Rotavirus Vaccines
• Intervention / Treatment: Procedure: Sample collection

• Study Type: Observational
• Enrollment (Actual): 643

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • GSK Investigational Site
  • Bruxelles, Belgium, 1020
    • GSK Investigational Site
  • Bruxelles, Belgium, 1070
    • GSK Investigational Site
  • Bruxelles, Belgium, 1050
    • GSK Investigational Site
  • Bruxelles, Belgium, 1180
    • GSK Investigational Site
  • Chimay, Belgium, 6460
    • GSK Investigational Site
  • Deinze, Belgium, 9800
    • GSK Investigational Site
  • Deurne, Belgium, 2100
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Eeklo, Belgium, 9900
    • GSK Investigational Site
  • Genk, Belgium, 3600
    • GSK Investigational Site
  • Gent, Belgium, 9000
    • GSK Investigational Site
  • Gosselies, Belgium, 6041
    • GSK Investigational Site
  • Hasselt, Belgium, 3500
    • GSK Investigational Site
  • Heusden, Belgium, 3550
    • GSK Investigational Site
  • Hornu, Belgium, 7301
    • GSK Investigational Site
  • Ieper, Belgium, 8900
    • GSK Investigational Site
  • Kortrijk, Belgium, 8500
    • GSK Investigational Site
  • Merksem, Belgium, 2170
    • GSK Investigational Site
  • Mons, Belgium, 7000
    • GSK Investigational Site
  • Namur, Belgium, 5000
    • GSK Investigational Site
  • Nivelles, Belgium, 1400
    • GSK Investigational Site
  • Oostende, Belgium, 8400
    • GSK Investigational Site
  • Ottignies, Belgium, 1340
    • GSK Investigational Site
  • Roeselaere, Belgium, 8800
    • GSK Investigational Site
  • Sint-Niklaas, Belgium, 9100
    • GSK Investigational Site
  • Sint-Truiden, Belgium, 3800
    • GSK Investigational Site
  • Tongeren, Belgium, 3700
    • GSK Investigational Site
  • Wilrijk, Belgium, 2610
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The confirmed cases are children born after 01 October 2006, at least 14 weeks of age, hospitalized for SGE during the designated study period and whose stool samples have been tested positive for RV by polymerase chain reaction (PCR). The controls are those children hospitalised or visiting the hospital outpatient clinic for non-GE causes at the study hospitals during the same time-period as the case and will be included after matching by age.

Description

Inclusion Criteria:

For confirmed cases:

• A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of hospital admission.
• Child admitted at the study hospital for SGE during the study period.
• Onset of SGE ≤ 14 days prior to admission.
• Written informed consent obtained and signed from the parent or guardian of the child.
• Stool samples collected during the first 48 hours of hospitalisation and then tested positive for RV by PCR.

For controls:

• A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of the hospital admission or visit to the hospital outpatient clinic.
• Hospitalised or visiting the hospital outpatient clinic for non-GE causes at the same hospital during the same time-period, as the probable case.
• Born within ±2 weeks from the date of birth of the case. If the list of children born within ±2 weeks is exhausted, then the range will be extended to ±4 weeks. In case a suitable control is not found even then, the range will be extended to ±6 weeks.
• Written informed consent obtained and signed from the parent or guardian of the child.

Exclusion Criteria:

For cases:

• Child has previously participated as a case or a control in this study, either in the same hospital or in another study hospital.
• Onset of SGE >48 hours after admission to the hospital (nosocomial infections).
• Child with a condition where rotavirus vaccination would be contraindicated.

For controls:

• Child has participated in the past as a case or control in this study, either in the same hospital or in another study hospital.
• Child who has symptoms of GE/ SGE during current hospital stay/ visit to the hospital outpatient clinic or on the day of interview of his/her parent or guardian.
• Child with a condition where rotavirus vaccination would be contraindicated.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Cases	Procedure: Sample collection; Stool sample
Group 2; Controls	Procedure: Sample collection; Stool sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children	More than 14 days after receipt of vaccine

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children	More than 14 days after receipt of vaccine
Occurrence of PCR-confirmed RV SGE in children who received at least one dose of Rotarix or Rotateq in unvaccinated children	More than 14 days after receipt of vaccine
Occurrence of SGE due to RV among children born after 01 October 2006, at least 14 weeks of age and admitted to hospital	Average time frame: 1 year from the date of subject enrolment
Occurrence of co-infections with other organisms among children born after 1 October 2006, at least 14 weeks of age and hospitalized with PCR-confirmed RV SGE	Average time frame: 1 year from the date of subject enrolment
Occurrence of PCR-confirmed RV SGE by age and month of year, among children born after 01 October 2006, at least 14 weeks of age and admitted to the hospital	Average time frame: 1 year from the date of subject enrolment
Occurrence of RV serotypes among hospitalized PCR-confirmed RV SGE children born after 01 October 2006 and at least 14 weeks of age	Average time frame: 1 year from the date of subject enrolment

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Braeckman T, Van Herck K, Meyer N, Pircon JY, Soriano-Gabarro M, Heylen E, Zeller M, Azou M, Capiau H, De Koster J, Maernoudt AS, Raes M, Verdonck L, Verghote M, Vergison A, Matthijnssens J, Van Ranst M, Van Damme P; RotaBel Study Group. Effectiveness of rotavirus vaccination in prevention of hospital admissions for rotavirus gastroenteritis among young children in Belgium: case-control study. BMJ. 2012 Aug 8;345:e4752. doi: 10.1136/bmj.e4752.
• Braeckman T et al. Vaccine effectiveness against Community-Acquired severe Rotavirus gastroenteritis among infants, in Belgium: A hospital-based, prospective, case control study. Abstract presented at the 11th International Symposium on Double-Stranded RNA Viruses, San Juan, Puerto Rico, 27 Nov - 01 Dec 2012.
• Matthijnssens J et al. Genotype-specific vaccine effectiveness against rotavirus gastroenteritis hospitalisation among young children in Belgium. Abstract presented at the 11th International Symposium on Double-Stranded RNA Viruses, San Juan, Puerto Rico, 27 Nov - 01 Dec 2012.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2008
• Primary Completion (Actual): June 11, 2010
• Study Completion (Actual): June 11, 2010

Study Registration Dates

• First Submitted: August 6, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Children; effectiveness; Gastroenteritis; Hospitalized; Rotavirus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Reoviridae Infections; Gastroenteritis; Rotavirus Infections
• Other Study ID Numbers: 111426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Study Data/Documents

1. Clinical Study Report
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 111426
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register