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Varicella Vaccination With Pulmicort

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641446
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   10 Months to 8 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641446

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

No publications provided

Responsible Party: Lars-Göran Carlsson
ClinicalTrials.gov Identifier: NCT00641446     History of Changes
Other Study ID Numbers: SD-004-0758, D5257C00758
Study First Received: March 18, 2008
Last Updated: March 24, 2009
Health Authority: Puerto Rico: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Children
Asthma
Varivax
varicella
Pulmicort
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014