The effect and influence of seasonal prophylactic influenza vaccination to the immunesystem in patients receiving PD-1 melanoma treatment

Phase 1

• Conditions: Metastatic melanoma; MedDRA version: 20.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003616-49-FI
• Lead Sponsor: Finnish Melanoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Melanoma patients on anti-PD1 antibody therapy, aged >18 years, written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Any confirmed / suspected immunosuppressive/ immunodeficient condition, including HIV-infection, administration (>14 days) of immunosupressive or immune-modifying drugs within 6 months before vaccination, i.e. oral corticosteroids (Prednisolone > or = 20 mg/ day or equivalent). Inhaled or topical steroids are permitted. Pregnancy or lactation. Acute infection at the time of the enrolment. Contraindication for innfluenza vaccination

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified