Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01887496
Other study ID # VARICOMP
Secondary ID
Status Completed
Phase N/A
First received November 12, 2012
Last updated July 25, 2017
Start date September 2010
Est. completion date October 2012

Study information

Verified date July 2017
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Varicella infection is one of the common childhood infectious disease. While usually self-limiting, a case of varicella can develop complications -sometimes potentially serious- requiring hospitalizations including secondary bacterial infections (mainly at the skin and skin structure), respiratory complications (pneumonia or exacerbation of asthma), neurological complications (encephalitis and cerebellitis). Most hospitalizations for varicella occurred in children who were previously healthy and can cause significant long term sequele and mortality in immunocompetent as well as immunocompromised children. Incidence of varicella and related hospitalization rates changes according to climates and also the presence of vaccination. WHO recommended that routine childhood varicella vaccination be considered in countries where the disease is a relatively important public health and socioeconomic problem however live attenuated varicella introduced to the childhood immunization programmes in Australia, Canada, Germany, Greece, Qatar, Republic of Korea, Saudi Arabia, Taiwan, United States, Uruguay, and parts of Italy and Spain. Clinically and statistically significant reduction in varicella-related hospitalizations for children and adults associated with childhood varicella immunization and a corresponding significant decrease in hospital charges.

Epidemiological information on varicella complications in children is essential to develop immunization recommendation strategies. Economic analyses of varicella immunization are sensitive to the costs of hospitalized cases, so there is a need to validate varicella related hospitalization data at the country-based level. The data also provide a baseline for the data 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 hospitalization are limited and center-specific in Turkey and cannot provide sufficiently accurate information. Varicella infections have been commonly seen in children in Turkey and VZV seroprevalence increased with age and 70% at the age of 7 years and 90% in 15-19 years. Varicella vaccine is available in private practice in Turkey and estimated coverage is lower than 10%.

The aim of this multicenter study (VARICOMP study) to estimate the annual incidence of pediatric varicella related hospitalizations, describe the complications and estimate annual mortality and cost in children.


Recruitment information / eligibility

Status Completed
Enrollment 1800
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

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

- Previously healthy or with chronic disease or conditions

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The cost of varicella-related hospitalization in children. 2008-2013 (up to 5 years)
See also
  Status Clinical Trial Phase
Completed NCT02570126 - A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. Phase 3
Completed NCT00326183 - Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED) Phase 4
Completed NCT02452229 - Review of Human Herpes Viruses in Burns N/A
Completed NCT01815073 - Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine Phase 4
Completed NCT01817270 - Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine Phase 4
Active, not recruiting NCT01982409 - Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children Phase 4
Completed NCT00921999 - Immune Response to Varicella-Zoster Vaccination and Infection N/A
Completed NCT00098046 - Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection Phase 3
Completed NCT05732337 - Open Clinical Investigation to Evaluate the Effectiveness and Safety of a Topical Medical Device. N/A
Completed NCT01684072 - Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin Phase 4
Completed NCT00156559 - MMR and Varicella Vaccine in Premature Infants Phase 4
Active, not recruiting NCT05084508 - A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age Phase 2
Completed NCT04384016 - Safety and Immunogenicity of Skyvaricella Injection in Healthy Volunteer Vietnamese Children From 12 Months to 12 Years Old Phase 4
Completed NCT00001125 - Use of a Varicella-Zoster Virus (VZV) Vaccine to Prevent Shingles in HIV-Infected Children Who Have Already Had Chickenpox Phase 1
Completed NCT00000953 - Comparison of Brovavir Versus Acyclovir in the Treatment of Herpes in HIV-Infected Patients Phase 2
Completed NCT00002315 - A Comparison of 882C87 Versus Acyclovir in the Treatment of Herpes Zoster in Patients With Weakened Immune Systems Phase 3
Withdrawn NCT00001054 - The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Phase 1
Completed NCT00002358 - A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV Phase 3