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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01177826
Other study ID # 111426
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 23, 2008
Est. completion date June 11, 2010

Study information

Verified date December 2019
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 643
Est. completion date June 11, 2010
Est. primary completion date June 11, 2010
Accepts healthy volunteers No
Gender All
Age group 14 Weeks to 5 Years
Eligibility 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 Design


Intervention

Procedure:
Sample collection
Stool sample

Locations

Country Name City State
Belgium GSK Investigational Site Antwerpen
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Chimay
Belgium GSK Investigational Site Deinze
Belgium GSK Investigational Site Deurne
Belgium GSK Investigational Site Edegem
Belgium GSK Investigational Site Eeklo
Belgium GSK Investigational Site Genk
Belgium GSK Investigational Site Gent
Belgium GSK Investigational Site Gosselies
Belgium GSK Investigational Site Hasselt
Belgium GSK Investigational Site Heusden
Belgium GSK Investigational Site Hornu
Belgium GSK Investigational Site Ieper
Belgium GSK Investigational Site Kortrijk
Belgium GSK Investigational Site Merksem
Belgium GSK Investigational Site Mons
Belgium GSK Investigational Site Namur
Belgium GSK Investigational Site Nivelles
Belgium GSK Investigational Site Oostende
Belgium GSK Investigational Site Ottignies
Belgium GSK Investigational Site Roeselaere
Belgium GSK Investigational Site Sint-Niklaas
Belgium GSK Investigational Site Sint-Truiden
Belgium GSK Investigational Site Tongeren
Belgium GSK Investigational Site Wilrijk

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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.

Braeckman T, Van Herck K, Meyer N, Pirçon JY, Soriano-Gabarró 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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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