Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01445002
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2011-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
Sponsor:
Biomay AG
Organization:
Study Overview
Official Title:
Safety and Dose Finding Study Based on the Effects of Three Subcutaneous Injections of BM32, a Recombinant Hypoallergenic Grass Pollen Vaccine, on Responses to Allergen Challenge by Skin Testing and in the Vienna Challenge Chamber (VCC) as Well as Immunological Response in Subjects Know to Suffer From Grass-pollen Induced Allergic Rhinitis
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by:
* skin prick testing
* grass pollen inhalation challenge
* antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.
* skin prick testing
* grass pollen inhalation challenge
* antibody responses. In addition, the safety of subcutaneous application of BM32 will be evaluated.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2011-003368-64 | EUDRACT_NUMBER | None | View |