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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

643 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-23

Study Completion Date

2010-06-11

Brief Summary

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

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Detailed Description

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Conditions

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Infections, Rotavirus Rotavirus Vaccines

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Cases

Sample collection

Intervention Type PROCEDURE

Stool sample

Group 2

Controls

Sample collection

Intervention Type PROCEDURE

Stool sample

Interventions

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Sample collection

Stool sample

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

14 Weeks

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Antwerp, , Belgium

Site Status

GSK Investigational Site

Brussels, , Belgium

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GSK Investigational Site

Brussels, , Belgium

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GSK Investigational Site

Brussels, , Belgium

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GSK Investigational Site

Brussels, , Belgium

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GSK Investigational Site

Chimay, , Belgium

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GSK Investigational Site

Deinze, , Belgium

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GSK Investigational Site

Deurne, , Belgium

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GSK Investigational Site

Edegem, , Belgium

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GSK Investigational Site

Eeklo, , Belgium

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GSK Investigational Site

Genk, , Belgium

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GSK Investigational Site

Ghent, , Belgium

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GSK Investigational Site

Gosselies, , Belgium

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GSK Investigational Site

Hasselt, , Belgium

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GSK Investigational Site

Heusden, , Belgium

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GSK Investigational Site

Hornu, , Belgium

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GSK Investigational Site

Ieper, , Belgium

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GSK Investigational Site

Kortrijk, , Belgium

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GSK Investigational Site

Merksem, , Belgium

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GSK Investigational Site

Mons, , Belgium

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GSK Investigational Site

Namur, , Belgium

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GSK Investigational Site

Nivelles, , Belgium

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GSK Investigational Site

Ostend, , Belgium

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GSK Investigational Site

Ottignies, , Belgium

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GSK Investigational Site

Roeselaere, , Belgium

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GSK Investigational Site

Sint-Niklaas, , Belgium

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GSK Investigational Site

Sint-Truiden, , Belgium

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GSK Investigational Site

Tongeren, , Belgium

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GSK Investigational Site

Wilrijk, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND

PMID: 22875947 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Study Documents

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