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Phase II Study of Grass Pollen Allergy Vaccine BM32

NCT01538979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2015-12-18

No results posted yet for this study

Summary

The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.

Conditions

  • Grass Pollen Allergy

Interventions

BIOLOGICAL

BM32

Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season

BIOLOGICAL

BM32

Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season

BIOLOGICAL

Placebo

Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections

Sponsors & Collaborators

  • Biomay AG

    lead INDUSTRY

Principal Investigators

  • Johannes Ring, Prof. · Technical University Munich, Klinik und Poliklinik für Dermatologie and Allergologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Austria
  • Belgium
  • Denmark
  • Germany
  • Netherlands
  • Slovenia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538979 on ClinicalTrials.gov