Immunogenicity and Safety Evaluation of AdimFlu-S (QIS) in Healthy Subjects.

Phase 1

• Conditions: healthy volunteers; MedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001557-41-BE
• Lead Sponsor: Adimmune Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-09
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

1. Males or non-pregnant females and aged =18 years;
2. Stable health status is defined by the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment;
3. Willing and able to adhere to visit schedules and all study requirements. If necessary, the burden of a site visit can be removed by a subject-centric approach. At investigators’ discretion, registered nurses and technology can be used in off-site facilities such as nursing home for subject recruitment, monitoring, and sample collection;
4. Subjects are willing to provide signed study-specific 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 630
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1470

Exclusion Criteria

1. Subjects received seasonal influenza vaccine within 6 months prior to study vaccination;
2. Clinically or virologically confirmed influenza infection within 6 months preceding the study start;
3. Any known or suspected allergy to any constituent of influenza vaccines (including but not limited to egg proteins) or a history of severe adverse reaction to a previous influenza vaccine;
4. Personal or family history of Guillain-Barré Syndrome;
5. Diagnosed coagulant function abnormality (e.g. clotting factor deficiency, clotting hemorrhagic disease, abnormal platelet function);
6. An acute febrile illness within 1 week prior to vaccination;
7. Subjects with influenza-like illness as defined by the presence of fever (temperature = 38.0°C).
8. Female subjects who are pregnant, lactating or likely to become pregnant during the study; also women of childbearing potential who disagree to use an acceptable method of contraception (e.g. hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
9. Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
10. Treatment with an investigational drug or device within 3 months prior to study vaccination;
11. Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection;
12. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to = 20 mg/day of prednisone or equivalent for persons for > 2 weeks. Inhaled and topical steroids are allowed;
13. Receipt of live virus vaccine (both licensed and investigated) within 1 month prior to study vaccine or expected receipt within 1 month after study vaccination; receipt of any inactivated vaccine (both licensed and investigated) within 2 weeks prior to study vaccination or expected receipt within 1 month after study vaccination;
14. Receipt of any blood products, including immunoglobulin, within 3 months prior to study vaccination, which might interfere with assessment of the immune response;
15. Underlying condition which in the investigators’ opinion may interfere with evaluation of the study vaccine or prevents the subject from participating in the study.

Study & Design

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