NCT01887496

Brief Summary

Epidemiological information on varicella complications in children is essential for the development of appropriate immunization recommendations. Economic analyses of varicella immunization are sensitive to the costs of hospitalized cases, so there is a need to validate varicella-related hospitalization data in a country-specific manner. These data also provide a baseline for comparison with data collected after routine varicella immunization to evaluate the overall impact and cost-effectiveness of varicella immunization programs. Knowledge about the cause and incidence of varicella-related hospitalizations in Turkey is limited, center-specific and not sufficiently accurate. The aim of this multicenter study (VARICOMP) was to estimate the annual incidence of pediatric varicella-related hospitalization, describe the associated complications and estimate the annual mortality and economic cost of these cases.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 27, 2013

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

2.1 years

First QC Date

November 12, 2012

Last Update Submit

July 25, 2017

Conditions

Keywords

VaricellaTurkeyhospitalizationvaricella vaccine

Outcome Measures

Primary Outcomes (1)

  • Annual incidence of varicella-related hospitalization

    The primary goal of this study was to estimate the annual incidence of hospitalization resulting from varicella and to describe the associated complications.

    Hospitalization rate between 2008-2013 (up to 5 years)

Secondary Outcomes (1)

  • The cost of varicella-related hospitalization in children.

    2008-2013 (up to 5 years)

Study Arms (1)

Chickenpox complications

Cases were identified by International Classification of Disease of the Tenth Revision (ICD-10) diagnostic codes for chickenpox infection or chickenpox-associated complications, if available.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

0-18 years old hospitalized children due to varicella and -related complications

You may qualify if:

  • years old hospitalized children due to varicella and -related complications
  • Previously healthy or with chronic disease or conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Ener C Dinleyici, MD

    Eskisehir Osmangazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Pediatrics

Study Record Dates

First Submitted

November 12, 2012

First Posted

June 27, 2013

Study Start

September 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

July 28, 2017

Record last verified: 2017-07