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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allergovac himenoptera | Biological | Treatment with allergy vaccine againts Apis mellifera, Vespula spp or Polistes dominula |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by WAO classification | All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations. | During 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of vaccine evaluating re-sting test | Grade of treatment protection after controlled sting | Result of the re-sting test |
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Inclusion Criteria:
1. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.
2. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
3. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.
Exclusion Criteria:
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People with allergy to himenoptera venom.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María Cruz Gómez, MP | Contact | +34 944438000 | maricruz.gomez@roxall.es | |
| Leire Begoña | Contact | +34 944438000 | leire.begona@roxall.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vega Baja Orihuela | Recruiting | Orihuela | Alicante | 03314 | Spain |
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| Hospital Mexoeiro | Completed | Vigo | Pontevedra | 36313 | Spain |
| C.H.U. A Coruña | Recruiting | A Coruña | 15006 | Spain |
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| Hospital Santa Maria | Recruiting | Lleida | 25198 | Spain |
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| Hospital Fundación Alcorcón | Recruiting | Madrid | 28922 | Spain |
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| Hospital Universitario Reina Sofia | Not yet recruiting | Murcia | Spain |
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| Hospital Joan XXIII | Recruiting | Tarragona | 43005 | Spain |
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| Hospital Universitario La Fe | Recruiting | Valencia | 46026 | Spain |
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