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Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom

Spain50 participantsStarted 2019-05-23

Plain-language summary

It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.

Who can participate

Age range14 Years

SexALL

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Exclusion criteria

✕. Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
✕. Patients under treatment with immunotherapy against aeroallergens.
✕. Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
✕. Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
✕. Patients who are participating in another clinical trial or observational study.

What they're measuring

Number of participants with treatment-related adverse events as assessed by WAO classification

Timeframe: During 1 year

Trial details

NCT IDNCT04112797

SponsorRoxall Medicina España S.A

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-11

Contact for this trial

María Cruz Gómez, MP

+34 944438000 maricruz.gomez@roxall.es

View on ClinicalTrials.gov More Allergy to Himenoptera Venom trials