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

Infections, Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01177826
• Other study ID #: 111426
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Gastroenteritis
• Infections, Rotavirus
• Rotavirus Infections
• Rotavirus Vaccines

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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