Varicella Vaccination With Pulmicort

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: budesonide; Drug: varicella zoster virus

• Registration Number: NCT00641446
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	budesonide	Pulmicort
2	varicella zoster virus	Varivax

Primary Outcome Measures

Name	Time	Method
Seroconversion level	Week 6