Last updated: 10/19/2020 06:20:03

Number of rotavirus (RV) related hospitalizations in Belgium – season 2006-2007

GSK study ID
116311
Clinicaltrials.gov ID
NCT01563146
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Assessing the number of rotavirus related hospitalizations in 11 hospitals in Belgium – season 2006-2007
Trial description: This study aims to collect data and assess the number of rotavirus related hospitalizations in 11 hospitals in Belgium – season 2006-2007 in order to develop proper age-cohort analysis over time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Determination of the absolute number of rotavirus related hospitalisations in children up to five years old.

Timeframe: From June 1st 2006 up to 1 year

Secondary outcomes:

Classification of patients with rotavirus hospitalisation by birth cohorts, gender, time of the event, vaccine coverage status.

Timeframe: From June 1st 2006 up to 1 year

Determination of the duration of rota-related hospitalisation for community acquired and nosocomial infection per birth cohort.

Timeframe: From June 1st 2006 up to 1 year

Evaluation of the herd effect.

Timeframe: From June 1st 2006 up to 1 year

Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    2017-31-12
    Observational study model:
    Ecologic or Community
    Time perspective:
    Retrospective
    Clinical publications:
    Standaert B, Strens D, Alwan A, Raes M. Medium- to Long-Term Impact of Rotavirus Vaccination on Hospital Care in Belgium: A 7-Year Follow-Up of the Rotavirus Belgium Impact Study (RotaBIS). Infect Dis Ther. 2016 Mar;5(1):31-44. doi: 10.1007/s40121-015-0099-1.
    Standaert B, Strens D, Li X, Schecroun N, Raes M. The sustained rotavirus vaccination impact on nosocomial infection, duration of hospital stay, and age: the RotaBIS study (2005-2012). Infect Dis Ther. 2016;5(4):509-524.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    February 2016 to December 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 5 years
    Accepts healthy volunteers
    No
    • Child aged ≤5 years;
    • A stool sample has been provided for a rotavirus detection test during the study period;
    • Not applicable.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Child aged ≤5 years;

      • A stool sample has been provided for a rotavirus detection test during the study period;
      • Laboratory test result of rotavirus is available.
    Exclusion criteria:
    • Not applicable.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-12
    Actual study completion date
    2017-31-12

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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