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

The effect of seasonal prophylactic influenza vaccination and factors influencing the patients' immune-competence during anti-PD-1 treatment of patients with melanoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003616-49-FI

Enrollment

Registered

2018-10-30

Start date

2018-11-08

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic melanoma MedDRA version: 20.0 Level: LLT Classification code 10027481 Term: Metastatic melanoma System Organ Class: 100000004864

Interventions

Trade Name: VaxigripTetra Product Name: VaxigripTetra Pharmaceutical Form: Solution for injection in pre-filled syringe Trade Name: Opdivo Product Name: Opdivo Pharmaceutical Form: Concentrate for so

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the presence and titer of antibodies against circulating influenza virus strains and vaccine strains from pre- and post vaccination serum samples;Secondary Objective: To evaluate incidense of infections of the study population during follow-up, record toxity and efficasy of anti-PD1 therapy and compare results to published data;Primary end point(s):	—

Countries

Finland

Contacts

Public ContactMicaela Hernberg

HUS Comprehensive cancer center

micaela.hernberg@hus.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026