Varicella Vaccination With Pulmicort

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: budesonide; Drug: varicella zoster virus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641446

D5257C00758

SD-004-0758

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 10 months to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

1

Experimental group

Description:

Pulmicort

Treatment:

Drug: budesonide

2

Active Comparator group

Description:

Varivax

Treatment:

Drug: varicella zoster virus