Varicella Vaccination With Pulmicort | NCT00641446

Studies
Varicella Vaccination With Pulmicort

NCT00641446

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Mar 25, 2009Estimated

Enrollment

250Estimated

Phase

Phase 4

Conditions

Asthma

Interventions

budesonide
varicella zoster virus

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D5257C00758

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Oct 2003Actual

Completion Date

Oct 2003Actual

First Submitted Date

Mar 18, 2008

First Submission Date that Met QC Criteria

Mar 21, 2008

First Posted Date

Mar 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Pulmicort	Drug: budesonide
2	Active Comparator	Varivax	Drug: varicella zoster virus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
budesonide	Drug		1	Pulmicort
varicella zoster virus

Measure	Description	Time Frame
Seroconversion level		Week 6

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Months

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bertill Andersson	AstraZeneca employee	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D002644	Chickenpox

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide
D019433	Chickenpox Vaccine

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided