Varicella Vaccination With Pulmicort

NCT ID: NCT00641446

Last Updated: 2009-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-10-31

Brief Summary

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

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pulmicort

Group Type: EXPERIMENTAL

budesonide

Intervention Type: DRUG

2

Varivax

Group Type: ACTIVE_COMPARATOR

varicella zoster virus

Intervention Type: DRUG

Interventions

budesonide

Intervention Type: DRUG

varicella zoster virus

Intervention Type: DRUG

Other Intervention Names

Pulmicort; Varivax

Eligibility 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

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bertill Andersson

Role: STUDY_DIRECTOR

AstraZeneca employee

Other Identifiers

D5257C00758

Identifier Type: -

Identifier Source: secondary_id

SD-004-0758

Identifier Type: -

Identifier Source: org_study_id