| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Immunisation of adults 18 years of age and older against influenza infection. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10022000 |
| E.1.2 | Term | Influenza |
|
| 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 assess the lot-to-lot consistency of three lots of D-QIV vaccine in terms of haemagglutination inhibition (HI) antibody geometric mean titres (GMTs).
To assess the immunological non-inferiority (in terms of HI antibody GMTs and seroconversion rates (SCRs)) of the D-QIV vaccine compared to TIV-1 (Fluarix) and TIV-2 vaccines for the three strains that are included in each of TIV-1 (Fluarix) and TIV-2 vaccines.
To assess the immunological superiority (in terms of HI antibody GMTs and seroconversion rates (SCRs)) of the D-QIV vaccine compared to TIV-1 (Fluarix) and TIV-2 vaccines for the B strain that is not included in each TIV vaccine. |
|
| E.2.2 | Secondary objectives of the trial |
To describe the immunogenicity of D-QIV vaccine, TIV-1 (Fluarix) vaccine and TIV-2 vaccine in terms of GMTs and SPR at Days 0 and 21, and SCR and MGI at Day 21 overall and in each age stratum.
To assess the reactogenicity and safety of D-QIV, TIV-1 (Fluarix) and TIV-2 vaccines overall and in each age stratum in terms of:
Solicited local symptoms during the 7-day post-vaccination follow-up (day of vaccination and 6 subsequent days).
Solicited general symptoms during the 7-day post-vaccination follow-up (day of vaccination and 6 subsequent days).
Unsolicited symptoms during the 21-day (day of vaccination and 20 subsequent days) post-vaccination follow-up period.
Serious adverse events (SAEs), AEs with medically attended visit (MAV) and potential immune mediated disease (pIMDs) during the entire study period
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•A male or female 18 years of age or older at the time of the first vaccination.
•Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•Written informed consent obtained from the subject before any study procedure.
•Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study .
Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
has practiced adequate contraception for 30 days prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
|
|
| E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
•Administration of an influenza vaccine during the 6 months preceding entry into the study.
•Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Visit 2.
•Any contra-indication to intramuscular administration of the influenza vaccines.
•History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines including latex.
•Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab) within 3 months before study start, or planned administration during the study period.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral or axillary setting. The preferred route for recording temperature in this study will be axillary.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•History of Guillain-Barre syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine
•Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•Pregnant or lactating female.
•History of chronic alcohol consumption and/or drug abuse.
•Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
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|
| E.5 End points |
| E.5.1 | Primary end point(s) |
•Humoral immune response in terms of HI antibodies
Serum HI antibody titres against the four influenza vaccine strains will be used to calculate:
GMTs at Day 0 and Day 21
SCRs at Day 21
|
|
| 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 |
|
| 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 |
|
| 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 | Yes |
| E.8.2.3.1 | Comparator description |
| GlaxoSmithKline (GSK) Biologicals’ trivalent seasonal influenza vaccine TIV-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 | 13 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| 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 | Information not present in EudraCT |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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