Feasibility of Conducting a Study Comparing High-Dose Influenza Vaccines to Standard-Dose Influenza Vaccines in Danish Citizens Aged 65-79 Years

Phase 1

• Conditions: Prevention of influenza infection in adults aged 65-79 years; MedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-003170-31-DK
• Lead Sponsor: Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Herlev and Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-10
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40000

Inclusion Criteria

1. Persons aged 65-79 years are eligible for inclusion into this trial
2. Informed consent form has been signed and dated
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40000

Exclusion Criteria

1. Allergy/hypersensitivity towards the influenza vaccines used in this study
2. The presence of any contraindication towards vaccination at the day of vaccination

Study & Design

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