Observational Study on Rotavirus Gastroenteritis Epidemiology, Impact of Lyophilised vs. Liquid Formulation of Rotarix™

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435967
First received: September 9, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

The aim of this study is to monitor any impact in the change from the lyophilised formulation to the liquid formulation of the Rotarix™ vaccine on hospitalisations for rotavirus gastroenteritis. This is planned to be assessed by comparing trends of hospitalisations due to laboratory confirmed rotavirus gastroenteritis in children <=5 years of age, before and after introduction of the liquid formulation of the vaccine in Belgium.


Condition Intervention
Infections, Rotavirus
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Observational, Ecological, Database Study on Epidemiology of Hospitalisations With Rotavirus Gastroenteritis Confirmed in Children Aged ≤5 Years, and Any Impact in the Change From Lyophilised to Liquid Formulation of Rotarix™, in Belgium

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of rotavirus in hospitalised children aged ≤5 years during pre-introduction, introduction and post-introduction period of liquid formulation Rotarix™ [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of rotavirus detected by laboratory tests in children of various age, gender and location (centre and region). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus detected by laboratory tests at a specific time (month and year). [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus detected by various types of rotavirus laboratory tests. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]
  • Occurrence of rotavirus vaccination with a specific brand of vaccine (Rotarix and RotaTeq) among children ≤5 years of age in the Belgian population. [ Time Frame: up to 2 years post-introduction of liquid formulation of Rotarix™. ] [ Designated as safety issue: No ]

Estimated Enrollment: 7000
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort A
Children aged <=5 years in Belgium, with opportunity to receive Rotarix, requiring hospitalisation during which rotavirus detection test was performed and with available results.
Other: Data collection
Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children hospitalised due to laboratory confirmed rotavirus gastroenteritis in approximately 8 hospitals across Belgium.

Criteria

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Child aged ≤5 years with opportunity to receive lyophilised or liquid formulation of Rotarix™;
  • Hospitalised at one of the participating centres in Belgium;
  • A stool sample has been provided for a rotavirus detection test during the study period;
  • Laboratory test result of rotavirus is available.

Exclusion Criteria:

• None.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435967

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01435967     History of Changes
Other Study ID Numbers: 114061
Study First Received: September 9, 2011
Last Updated: March 6, 2014
Health Authority: Belgium: Agence Fédérale des Medicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
ecological
Observational
Rotarix™

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014