Clinical study in adults 50-64 years old to evaluate immunogenicity and safety of adjuvanted flu vaccine in comparison with a licensed non-adjuvanted flu vaccine

Phase 1

• Conditions: Prophylaxis of Influenza; MedDRA version: 20.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-001721-40-EE
• Lead Sponsor: Seqirus UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2018

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals 50 to 64 years of age (i.e. 50 to <64 years) on the day of informed consent;
2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry;
3. Individuals who can comply with study procedures including follow-up;
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination.

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 2018
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below:
1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the study vaccination;
2. Progressive, unstable or uncontrolled clinical conditions;
3. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study;
4. History of any medical condition considered an AESI;
5. Known history of Guillain Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis;
6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws;
7. Abnormal function of the immune system resulting from:
a. Clinical conditions;
b. Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to =20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also permitted;
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent;
8. Received immunoglobulins or any blood products within 180 days prior to informed consent;
9. Received an investigational or non-registered medicinal product within 30 days prior to informed consent, or who are unwilling to refuse participation in another clinical study at any time during the conduct of this study (notes: i. concomitant participation in a study not involving or no longer involving administration of drugs, vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase, observational studies); ii. concomitant participation in a COVID-19 vaccine study is acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion #11 is adhered to);
10. Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or plan to receive influenza vaccine during the study period;
11. Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID19 vaccine within 7 days from study vaccination;
12. Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated vaccine within 28 days prior to enrollment in this study or plan to receive any other non-influenza vaccine within 28 days from study vaccination;
13. Acute (severe) febrile illness;
14. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study;
15. Study personnel or immediate family members or household member of study personnel.

Study & Design

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