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Safety Study of Depigoid Vaccine Dermatophagoides Pteronyssinus or 50% Dermatophagoides Pteronyssinus / 50% Dermatophagoides Farinae (500 DPP/ml), to Treat Allergic Rhinitis or Rhinoconjunctivitis With or Without Asthma

NCT01591343 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-02-23

No results posted yet for this study

Summary

Safety study of Depigoid vaccine Dermatophagoides pteronyssinus or 50% Dermatophagoides pteronyssinus / 50% Dermatophagoides farinae (500 DPP/ml), to treat allergic rhinitis or rhinoconjunctivitis with or without asthma.

Primary variable: number of subjects \[%\] who experienced at least one immediate or delayed systemic reaction of EAACI grade 2 or higher during the 4-month treatment period.

Conditions

  • Allergic Rhinitis
  • Rhinoconjunctivitis
  • Mild Persistent Asthma
  • Mild Intermittent Asthma

Interventions

BIOLOGICAL

Depigoid® (500 DPP/ml)

Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml). Dose: Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection

Sponsors & Collaborators

  • Harrison Clinical Research

    collaborator INDUSTRY

  • Laboratorios Leti, S.L.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Spain

Study Locations

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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 NCT01591343 on ClinicalTrials.gov