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RECRUITING
NCT05395689
PHASE3

Efficacy and Safety Assessment of Beltavac® With Polymerized Extract of HDM

Sponsor: Probelte Pharma S.L.U.

View on ClinicalTrials.gov

Summary

The trial is performed to assess efficacy and safety of Beltavac with polymerized extract of house dust mites in allergic Rhinoconjunctivitis associated or not with asthma

Official title: Efficacy and Safety Assessment of a Subcutaneous Immunotherapy (Beltavac®) With Polymerized Allergenic Extract From House Dust Mites in Patients With Allergic Rhinitis/Rhinoconjuntivitis

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2022-01-17

Completion Date

2026-06

Last Updated

2024-07-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

House dust mites allergoid from Dermatophagoides pteronyssinus and Dermatophagoides farinae

The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

BIOLOGICAL

Placebo

The vaccine will be administered according to a rush schedule meaning one administration each month for 1 year

Locations (18)

Hospital Vega Baja

Orihuela, Alicante, Spain

Hospital General de Granollers

Granollers, Barcelona, Spain

Hospital de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital de la Plana

Castellon, Castellón, Spain

Hospital Regional de Málaga

Málaga, Málaga, Spain

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Fundacion Sanitaria Sant Pere Claver

Barcelona, Spain

Hospital de Bellvitge

Barcelona, Spain

Hospital Germans Trias i Pujol

Barcelona, Spain

Hospital infantil Vall d Hebron

Barcelona, Spain

Hospital Val d ' Hebron

Barcelona, Spain

Hospital General de Castellón

Castelló, Spain

Hospital Virgen de la Arrixaca

Murcia, Spain

Hospital de Fatima

Seville, Spain

Hospital Virgen Macarena

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Hospital Politecnico de la Fé

Valencia, Spain

Hospital Universitario Infantil de la Fé

Valencia, Spain