Varicella Vaccination With Pulmicort

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641446
• Other study ID #: SD-004-0758
• Secondary ID: D5257C00758
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2008
• Last updated: March 24, 2009
• Start date: October 2001
• Est. completion date: October 2003

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Puerto Rico: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Months to 8 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide

• varicella zoster virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion level		Week 6