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Completed

NCT Number: NCT01563146

Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2006-2007

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.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

About this study

This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2006 until the 31st of May 2007. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2006- May 31st 2007) and analysed for rotavirus, in children aged ≤5 years.

Primary outcomes

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

    Time frame: From June 1st 2006 up to 1 year

Secondary outcomes

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

    Time frame: From June 1st 2006 up to 1 year

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

    Time frame: From June 1st 2006 up to 1 year

  3. Evaluation of the herd effect.

    Time frame: From June 1st 2006 up to 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Assessing the Number of Rotavirus Related Hospitalizations in 11 Hospitals in Belgium - Season 2006-2007

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2012
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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