Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.

ConditionAllergy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorProbelte Pharma S.L.U.

About this trial

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients

Eligibility criteria

Qualifiers

Age 14 years or older at the time of study inclusion.

Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors.

Assent form duly signed and dated by the minor, when applicable.

Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous.

Disqualifiers

Patients with severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorders, or other relevant chronic diseases that may interfere with the study results.

Patients with known allergy to any of the vaccine excipients.

Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.

Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators