| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 | 19.0 |
| 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 |
|
| 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 |
| To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to FluarixTetra in terms of GMT of HAI antibodies and seroconversion rates (SCRs) against the 4 virus strains at 21 days post-immunization on the whole study population (i.e. non-elderly and elderly subjects together) |
|
| E.2.2 | Secondary objectives of the trial |
- To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to FluarixTetra in terms of GMT of HAI antibodies and SCR against the 4 virus strains at 21 days post-immunization according to 2 age categories (18-64 years old and ≥65 years old).
- To describe the immunogenicity of AdimFlu-S (QIS) and FluarixTetra in terms of GMTs and SPR at Day 0, 21 and 180 and SCR and GMTR at Day 21 and 180 in overall and each age subgroup (non-elderly 18-64 years old and elderly ≥65 years old).
- To demonstrate lot-to-lot consistency for AdimFlu-S (QIS) in terms of GMT of HAI antibody titers against the 4 vaccine strains at 21 days postimmunization.
- To evaluate the short term reactogenicity and safety and long term safety after administration of AdimFlu-S (QIS) overall and in each age subgroup (non-elderly 18-64 years old and elderly ≥65 years old). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| GMT of HAI antibodies and seroconversion rates (SCRs) against the 4 virus strains at 21 days post-immunization on the whole study population. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 21 days post-immunization |
|
| E.5.2 | Secondary end point(s) |
Demonstration of lot-to-lot consistency Immunogenicity of AdimFlu-S (QIS) and Fluarix Tetra in terms of HAI antibody titers: serum anti-hemagglutinin antibody against the four vaccine strains at baseline
and 21 days and 180 days after vaccination expressed as these endpoints:
- GMT at D0, D21 and D180;
- Individual post (D21 or D180) - to pre (D0)-vaccination GMTRs;
- SPR at D0, D21 and D180, seroprotection being defined as an HAI titer ≥1:40;
- SCR at D21 and D180, seroconversion being defined as:
*Either a pre-vaccination titer<1:10 and a post-vaccination titer ≥1:40, or
*A pre-vaccination titer ≥1:10 and a ≥4-fold increase in post-vaccination titer.
Description and comparison of immunogenicity of AdimFlu-S (QIS) and FluarixTetra in terms of VN or MN antibody titers at D0, D21 and D180 (30% of total subjects). |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | Yes |
| 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 | No |
| 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 | Yes |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| 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 | 8 |
| E.8.5 | The trial involves multiple Member States | No |
| 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 |
|
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
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