Status:
TERMINATED
Efficacy and Safety Study of TOLAMBA™ in Ragweed-Allergic Adults
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.
Detailed Description
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoi...
Eligibility Criteria
Inclusion
- Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete
- Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season
Exclusion
- Has had any hospital admissions for asthma
- Has smoked within the past year, or has a ≥10-pack per year smoking history
- Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™
- Has used Xolair within the past 12 months
- Has a history of anaphylaxis
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
738 Patients enrolled
Trial Details
Trial ID
NCT00387738
Start Date
April 1 2006
End Date
March 1 2008
Last Update
April 16 2019
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Center Of Research Excellence
Oxford, Alabama, United States, 36203
2
Atlanta Allergy & Asthma Clinic
Stockbridge, Georgia, United States, 30281
3
Clinical Research of Atlanta
Stockbridge, Georgia, United States, 30281
4
Sneeze, Wheeze, and Itch Associates
Normal, Illinois, United States, 61761