Clinical trial NCT01177826: Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Rotavirus Vaccines
Keywords: Hospitalized
Rotavirus
Children
effectiveness
Gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-08-09
Enrollment: 643
Sex: ALL
Minimum age (years): 14
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of PCR-confirmed rotavirus (RV) severe gastroenteritis (SGE) in children fully vaccinated with Rotarix or in unvaccinated children
timeFrame: More than 14 days after receipt of vaccine
Secondary outcomes:
measure: Occurrence of PCR-confirmed RV SGE in children who received one or two doses of Rotarix or in unvaccinated children
timeFrame: More than 14 days after receipt of vaccine
measure: Occurrence of PCR-confirmed RV SGE in children who received at least one dose of Rotarix or Rotateq in unvaccinated children
timeFrame: More than 14 days after receipt of vaccine
measure: Occurrence of SGE due to RV among children born after 01 October 2006, at least 14 weeks of age and admitted to hospital
timeFrame: Average time frame: 1 year from the date of subject enrolment
measure: 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
timeFrame: Average time frame: 1 year from the date of subject enrolment
measure: 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
timeFrame: Average time frame: 1 year from the date of subject enrolment
measure: Occurrence of RV serotypes among hospitalized PCR-confirmed RV SGE children born after 01 October 2006 and at least 14 weeks of age
timeFrame: Average time frame: 1 year from the date of subject enrolment
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Chimay
country: Belgium
facility: GSK Investigational Site
city: Deinze
country: Belgium
facility: GSK Investigational Site
city: Deurne
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Eeklo
country: Belgium
facility: GSK Investigational Site
city: Genk
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Gosselies
country: Belgium
facility: GSK Investigational Site
city: Hasselt
country: Belgium
facility: GSK Investigational Site
city: Heusden
country: Belgium
facility: GSK Investigational Site
city: Hornu
country: Belgium
facility: GSK Investigational Site
city: Ieper
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Merksem
country: Belgium
facility: GSK Investigational Site
city: Mons
country: Belgium
facility: GSK Investigational Site
city: Namur
country: Belgium
facility: GSK Investigational Site
city: Nivelles
country: Belgium
facility: GSK Investigational Site
city: Oostende
country: Belgium
facility: GSK Investigational Site
city: Ottignies
country: Belgium
facility: GSK Investigational Site
city: Roeselaere
country: Belgium
facility: GSK Investigational Site
city: Sint-Niklaas
country: Belgium
facility: GSK Investigational Site
city: Sint-Truiden
country: Belgium
facility: GSK Investigational Site
city: Tongeren
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.