Varicella Vaccination With Pulmicort - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Seroconversion level [ Time Frame: Week 6 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Varicella Vaccination With Pulmicort

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide
Drug: varicella zoster virus

Study Arms / Comparison Groups

Experimental: Pulmicort
Active Comparator: Varivax

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

250

Completion Date

October 2003

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Months to 8 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00641446

Responsible Party

Lars-Göran Carlsson

Study ID Numbers ^ICMJE

SD-004-0758, D5257C00758

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bertill Andersson

AstraZeneca employee

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP