Prophylaxis of Influenza MedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Seqirus UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity Objectives: 1. To demonstrate immunological noninferiority of aQIV versus a nonadjuvanted quadrivalent influenza comparator (QIV) in subjects 50-64 years of age, as measured by hemagglutination inhibition (HI) geometric mean titers (GMTs) and seroconversion rates (SCRs) for each vaccine strain, at 3 weeks after vaccination. 2. To demonstrate that aQIV induces a superior immune response compared with QIV in subjects 50-64 years of age as measured by HI GMTs at 3 weeks after vaccination for at least 2 of the 4 vaccine strains. ;Secondary Objective: Secondary Immunogenicity Objectives: 1. To demonstrate that aQIV induces a superior immune response compared with QIV in subjects 50-64 years of age as measured by HI GMT for at least one vaccine strain at 3 weeks after vaccination. 2. To demonstrate greater persistence of the immune response for at least one vaccine strain at 6 after vaccination with aQIV compared with QIV as measured by HI assay in subjects 50-64 years of age. 3. To evaluate the immunogenicity of aQIV compared with QIV as measured by HI in subjects 50-64 years of age. Secondary Safety Objective: To assess the safety and reactogenicity of aQIV and QIV in adults 50-64 years of age. ;Primary end point(s): Primary Immunogenicity Endpoint(s) Humoral immune responses in terms of HI antibody response against homologous egg-derived vaccine strains (A/H1N1, A/H2N3, B/Yamagata, and B/Victoria): - Geometric mean titer (GMT) of HI antibodies at Day 22; - Seroconversion rate (SCR) defined as the percentage of subjects with either a prevaccination HI titer <1:10 and a postvaccination (Day 22) HI titer =1:40, or with either a prevaccination HI titer =1:10 and a =4-fold increase in postvaccination HI titer. ;Timepoint(s) of evaluation of this end point: The immunogenicity of the study vaccines will be assessed 21 days (ie, on Day 22) after vaccine administration by measuring HI antibody titers to the A/H1N1, A/H3N2, B/Yamagat | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Safety Endpoints Safety and reactogenicity will be assessed by the frequency and severity of: - Solicited local and systemic AEs for 7 days following vaccination (Day 1 through Day 7); - All unsolicited AEs for 21 days following vaccination (Day 1 through Day 22); - SAEs, AEs leading to withdrawal from the study, AESIs as collected from Day 1 through Day 271. Secondary Immunogenicity Endpoint Humoral immune response in terms of HI antibody response against homologous egg-derived vaccine strains (A/H1N1, A/H2N3, B/Yamagata, and B/Victoria): - GMT of HI antibodies at Day 22 and Day 181. ;Timepoint(s) of evaluation of this end point: Secondary Safety Endpoints: Day 1 through Day 7, Day 1 through Day 22, Day 1 through Day 271. Secondary Immunogenicity Endpoint: Day 22 and Day 181. | — |
Countries
Estonia, Germany, United States
Contacts
Public ContactClinical Trial Disclosures
Seqirus UK Limited
Outcome results
None listed