allergovac polimerized (100/100)
BiologicalPatients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Other names: Allergovac Poliplus
NCT Number: NCT02849249
The study was designed according to the draft of allergenic product regulation published by Spanish Regulatory Agency. The aim of the study is to evaluate the safety and tolerability of subcutaneous immunotherapy with polimerized (100/100) mixture of pollens: Olea europaea and Phleum pratense in patients with rhinoconjunctivitis with or without associated mild asthma. In addition, surrogate efficacy parameters will be evaluated: immunoglobulin level changes and skin reactivity.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Hospital de Zafra, Zafra, Badajoz, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
Other names: Allergovac Poliplus
Time frame: Across 12-15 weeks treatment period
Time frame: At baseline and 1 week after last administered dose
Subrogate efficacy
Time frame: At baseline and 1 week after last administered dose
Subrogate efficacy parameter. The patients will undergo a skin prick test at baseline and 1 week after last administered dose. The wheal are in mm2 will be measured and the results of both time frames will be compared.
Roxall Medicina España S.A
Industry
A Prospective, Multicenter, Randomized, Controlled, Open Trial, Parallel Groups (1: 1), With Subcutaneous Polimerized Mix (100/100), in Patients With Rhinoconjunctivitis Sensitized to the Following Combination of Pollen: Timothy Grass and Olea Europaea, and Asministered by Different Schedules
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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