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Varicella Vaccination With Pulmicort

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641446
First Posted: March 24, 2008
Last Update Posted: March 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine

Condition Intervention Phase
Asthma Drug: budesonide Drug: varicella zoster virus Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Seroconversion level [ Time Frame: Week 6 ]

Estimated Enrollment: 250
Study Start Date: October 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pulmicort
Drug: budesonide
Other Name: Pulmicort
Active Comparator: 2
Varivax
Drug: varicella zoster virus
Other Name: Varivax

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641446


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bertill Andersson AstraZeneca employee
  More Information

Responsible Party: Lars-Göran Carlsson
ClinicalTrials.gov Identifier: NCT00641446     History of Changes
Other Study ID Numbers: SD-004-0758
D5257C00758
First Submitted: March 18, 2008
First Posted: March 24, 2008
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Children
Asthma
Varivax
varicella
Pulmicort
budesonide

Additional relevant MeSH terms:
Asthma
Chickenpox
Herpes Zoster
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists