Varicella Vaccination With Pulmicort

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00641446
• Collaborator: (none)
• Enrollment: 250
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2001
• Actual Primary Completion Date: Oct 1, 2003
• Actual Study Completion Date: Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pulmicort	Drug: budesonide; Other Names: Pulmicort
Active Comparator: 2 Varivax	Drug: varicella zoster virus; Other Names: Varivax

Outcome Measures

Primary Outcome Measures

1. Seroconversion level [Week 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Months to 8 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Bertill Andersson, AstraZeneca employee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00641446
• Other Study ID Numbers: SD-004-0758; D5257C00758
• First Posted: Mar 24, 2008
• Last Update Posted: Mar 25, 2009
• Last Verified: Mar 1, 2009

• Keywords provided by , ,: Children; Asthma; Varivax; varicella; Pulmicort; budesonide
• Additional relevant MeSH terms: Chickenpox; Herpes Zoster; Asthma; Budesonide

Study Results

No Results Posted as of Mar 25, 2009