Trials / Completed
CompletedNCT01506375
Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant
Safety, Clinical Tolerability and Immunogenicity of gpASIT+TM Administered Subcutaneously to Hay Fever Patients Either Alone or in Presence of DnaK Immunoregulating Adjuvant
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- BioTech Tools S.A. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to compare the safety, clinical tolerability, immunogenicity and efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating adjuvant, in a short course administration (5 injections over 4 weeks).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | gpASIT+TM | 1 subcutaneous injection every 7 days during 29 days |
| BIOLOGICAL | gpASIT+TM + adjuvant | 1 subcutaneous injection every 7 days during 29 days |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-01-01
- Completion
- 2013-04-01
- First posted
- 2012-01-10
- Last updated
- 2014-05-26
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT01506375. Inclusion in this directory is not an endorsement.