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

NCT01177826 | Completed

• 1 other identifier: 111426
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 29

Brief Summary

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

Conditions

Infections, Rotavirus; Rotavirus Vaccines

Keywords

Hospitalized; Rotavirus; Children; effectiveness; Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Group 1

Cases

Procedure: Sample collection

Group 2

Controls

Procedure: Sample collection

Interventions

Sample collection PROCEDURE

Stool sample

Group 1; Group 2

Eligibility Criteria

• Age: 14 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (29)

GSK Investigational Site

Antwerp, 2020, Belgium

Location

GSK Investigational Site

Brussels, 1020, Belgium

Location

GSK Investigational Site

Brussels, 1050, Belgium

Location

GSK Investigational Site

Brussels, 1070, Belgium

Location

GSK Investigational Site

Brussels, 1180, Belgium

Location

GSK Investigational Site

Chimay, 6460, Belgium

Location

GSK Investigational Site

Deinze, 9800, Belgium

Location

GSK Investigational Site

Deurne, 2100, Belgium

Location

GSK Investigational Site

Edegem, 2650, Belgium

Location

GSK Investigational Site

Eeklo, 9900, Belgium

Location

GSK Investigational Site

Genk, 3600, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Gosselies, 6041, Belgium

Location

GSK Investigational Site

Hasselt, 3500, Belgium

Location

GSK Investigational Site

Heusden, 3550, Belgium

Location

GSK Investigational Site

Hornu, 7301, Belgium

Location

GSK Investigational Site

Ieper, 8900, Belgium

Location

GSK Investigational Site

Kortrijk, 8500, Belgium

Location

GSK Investigational Site

Merksem, 2170, Belgium

Location

GSK Investigational Site

Mons, 7000, Belgium

Location

GSK Investigational Site

Namur, 5000, Belgium

Location

GSK Investigational Site

Nivelles, 1400, Belgium

Location

GSK Investigational Site

Ostend, 8400, Belgium

Location

GSK Investigational Site

Ottignies, 1340, Belgium

Location

GSK Investigational Site

Roeselaere, 8800, Belgium

Location

GSK Investigational Site

Sint-Niklaas, 9100, Belgium

Location

GSK Investigational Site

Sint-Truiden, 3800, Belgium

Location

GSK Investigational Site

Tongeren, 3700, Belgium

Location

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related Publications (3)

• 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.

  PMID: 22875947 BACKGROUND

• 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.

  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.

  BACKGROUND

Related 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples

MeSH Terms

Conditions

Rotavirus Infections; Gastroenteritis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2010
• First Posted: August 9, 2010
• Study Start: February 23, 2008
• Primary Completion: June 11, 2010
• Study Completion: June 11, 2010
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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.

Locations

BE (29)