E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against influenza of healthy adults |
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MedDRA Classification |
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 evaluate the humoral immune response (anti-haemagglutinin antibodies) against each vaccine strain 21 days after vaccination with FluLaval thiomersal-free, FluLaval thiomersal-containing and Fluarix vaccines in adult (18-60 years) and elderly (over 60 years) subjects. • To assess during the active phase study period (30 days) the safety and reactogenicity of FluLaval thiomersal-free, FluLaval thiomersal-containing and Fluarix vaccines.
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E.2.2 | Secondary objectives of the trial |
• To evaluate persistence of anti-HA antibodies for all subjects 120 days after one dose of FluLaval thiomersal-free, FluLaval thiomersal-containing, and Fluarix vaccines.. • To evaluate persistence of anti-HA antibodies 180 days after one dose of FluLaval thiomersal-free, FluLaval thiomersal-containing, and Fluarix vaccines in subjects not vaccinated during the 2008/2009 Flu season. • To assess during the entire study period (180 days) the safety and reactogenicity of FluLaval thiomersal-free, FluLaval thiomersal-containing and Fluarix vaccines.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Only subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. • A male or female aged 18 years or older at the time of the vaccination. • Written informed consent obtained from the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after vaccination. • Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent). For azoospermia, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. • Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g. > 45 years.
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E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to administration of the vaccine. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Administration of a vaccine not foreseen by the study protocol 30 days before vaccination or planned vaccination within the following 30 days. • Confirmed influenza infection within a year preceding the study start. • Administration of an influenza vaccine during Flu season 2007-2008. • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). • History of hypersensitivity to a previous dose of influenza vaccine • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg or chicken protein. • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F)) • Unstable chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period. • Pregnant or lactating female. • History of chronic alcohol consumption and/or drug abuse. • Female planning to become pregnant or planning to discontinue contraceptive precautions. • 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) |
Immunogenicity: Observed variables: • At Day 0 and 21: serum anti-HA antibody titre, against each of the three vaccine strains, in all subjects. Derived variables At Days 0 and 21 • Geometric mean titers (GMTs) of anti-HA antibody titers • Seroprotection rates At Day 21: • Seroconversion rates • Seroconversion factors Safety: • Occurrence, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms during a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination in each group. • Occurrence, intensity, duration and relationship to vaccination of unsolicited AEs during a 30 day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination in each group. • Occurrence and relationship to vaccination of serious adverse events during the entire study period in each group.
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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 | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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last subject - last visit |
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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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |