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Varicella Vaccination With Pulmicort

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. Identifier: NCT00641446
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : March 25, 2009
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Brief Summary:
A study to determine whether treatment with Pulmicort in children has any effect on the varicella vaccine

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide Drug: varicella zoster virus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
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
Study Start Date : October 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: 1
Drug: budesonide
Other Name: Pulmicort

Active Comparator: 2
Drug: varicella zoster virus
Other Name: Varivax

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

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.

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

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

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 identifier (NCT number): NCT00641446

Sponsors and Collaborators
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Study Director: Bertill Andersson AstraZeneca employee
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Responsible Party: Lars-Göran Carlsson Identifier: NCT00641446    
Other Study ID Numbers: SD-004-0758
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Herpes Zoster
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists