Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387738
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2006-10-11
Brief Title:
Efficacy and Safety Study of TOLAMBA in Ragweed-Allergic Adults
Sponsor:
Dynavax Technologies Corporation
Organization:
Dynavax Technologies Corporation
Study Overview
Official Title:
A Randomized Double-Masked Placebo-Controlled Multicenter Dose-Regimen Study of the Efficacy and Safety of TOLAMBA in Ragweed-Allergic Rhinitis Adults
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim data indicated that subjects exhibited no meaningful allergic disease during the first ragweed season making it impossible to measure treatment effect
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 avoidance of the allergen or medication It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance This study compares the safety and efficacy of two different dosing regimens of TOLAMBA with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons
Comparisons Subject-rated allergy symptoms of subjects treated with TOLAMBA dose-intense regimen or TOLAMBA lower-dose regimen compared with subjects treated with placebo
Comparisons Subject-rated allergy symptoms of subjects treated with TOLAMBA dose-intense regimen or TOLAMBA lower-dose regimen compared with subjects treated with placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None