NCT01682070

SUBLIVAC FIX Phleum Pratense DT/DRF

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Phleum Pratense in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Grass Pollen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Phleum pratense based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Phleum pratense compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Phleum pratense compared to placebo.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	SUBLIVAC FIX phleum prat.	Comparison of different dosages to placebo
BIOLOGICAL	Placebo

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-09-10
• Last updated: 2013-05-29

Locations

23 sites across 2 countries: Germany, Poland