Varicella Vaccination With Pulmicort

Verified by: AstraZeneca, March 2009
First Received: March 18, 2008 | Last Updated: March 24, 2009 | Phase: Phase 4 | Start Date: October 2001
Overall Status: Completed | Estimated Enrollment: 250
  • …
  • Tell a FriendPrint

A study to determine whether treatment with Pulmicort in children has any effect on the varicella...

Brief Summary

Official Title: “Rates of Seroconversion Following Varicella Vaccination of Asthmatic Children Between the Ages of One and Eight Years Treated With Pulmicort Respules® Versus Non-Steroidal Conventional Asthma Therapy”

A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: October 2003

Intervention(s) in this Clinical Trial

  • Drug: budesonide
  • Drug: varicella zoster virus

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Pulmicort
  • Active Comparator: 2
    • Varivax

Outcome Measures for this Clinical Trial

Primary Measures

  • Seroconversion level
    • Time Frame: Week 6

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Children between the age of 10 months and 8 years,
  • have asthma or shown recent signs suggesting asthma,
  • have a parent or guardian willing to comply with study requirements

Exclusion Criteria:

  • Varicella zoster immune globulin (VZIG) within 5 months prior to immunization,
  • Previous varicella immunization,
  • an immunization or allergy immunotherapy 4 weeks prior to immunization,
  • Severe asthma,
  • have another persistent lung disease,
  • have a planned hospitalization for the duration of study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Months

Maximum Age for this Clinical Trial: 8 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Bertill Andersson Study Director AstraZeneca employee  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641446

Study ID Number: SD-004-0758

ClinicalTrials.gov Identifier: NCT00641446

Health Authority: Puerto Rico: Food and Drug Administration

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00641446