Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

PHASE3CompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

March 31, 2010

Conditions
Pollen Allergy
Interventions
BIOLOGICAL

Birch pollen allergoid

Subcutaneous injections were applied in the upper arm. Vials with three different concentrations were used: Strength A (1000 TU/mL), strength B (10 000 TU/mL) and strength 0 (100 TU/mL) by dilution of strength A.

OTHER

Placebo

Sterile aluminium hydroxide suspension for subcutaneous injection were applied in the upper arm. Vials with strength A contained 0.0125 mg/mL and with strength B 0.125 mg/mL histamine-dihydrochloride and strength 0 was produced by dilution of strength A. The vials containing the placebo solution were identical in their outer appearance with the active study preparation of the birch pollen allergoids.

Trial Locations (1)

21465

Allergopharma Joachim Ganzer KG, Reinbek

All Listed Sponsors
lead

Allergopharma GmbH & Co. KG

INDUSTRY

NCT00263627 - Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens | Biotech Hunter | Biotech Hunter