| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10022000 |
| E.1.2 | Term | Influenza |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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.
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| E.2.2 | Secondary objectives of the trial |
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 months 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.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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.
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| E.4 | Principal 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.
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| E.5 End points |
| E.5.1 | 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.
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| E.5.1.1 | 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/Yamagata, and B/Victoria strains included in the vaccines.
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| E.5.2 | 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.
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| E.5.2.1 | 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. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | Yes |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
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| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
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| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Nonadjuvanted flu vaccine comparator |
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| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 17 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| United States |
| Estonia |
| Germany |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as the completion of the testing of such biological samples, to be achieved no later than 8 months after collection of the last biological sample at Visit 6 (Day 271).
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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