E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against influenza disease in an elderly population aged over 65 years and in adult aged 18-40 years old. |
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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 safety and reactogenicity of repeated vaccination with FluAS25 in elderly subjects (previously enrolled in the ≥ 65 years age group), during the 21 days following the intramuscular administration of the vaccine. Fluarix administered to young adults (previously enrolled in the 18-40 years age group) and to elderly subjects (previously enrolled in the ≥ 65 years age group) will be used as reference. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of repeated vaccination with FluAS25 during the entire study period (Day 0 to 180) in terms of incidence of serious adverse events and medically significant conditions, following the intramuscular administration of the vaccine. Fluarix administered to young adults (previously enrolled in the 18-40 years age group) and to elderly subjects (previously enrolled in the ≥ 65 years age group) will be used as reference. • To evaluate in all subjects the immunogenicity (antihaemagglutinin antibody titers, seroconversion factor, seroconversion rate and seroprotection rate) 21 days following revaccination with FluAS25 or with Fluarix. • To evaluate the cell-mediated immune response induced by the study vaccines in terms of frequency of influenza-specific CD4/CD8 T lymphocytes producing at least two different cytokines (IFN-γ, IL-2, CD40L, or TNF-α) 21 days following revaccination with FluAS25 or with Fluarix (for CMI subset of subjects only). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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) should be enrolled in the study. • Written informed consent obtained from the subject. • Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed 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 completion of the vaccination series. • Male or female subjects who participated in the FluAS25-005 study and were enrolled in the ≥ 65 years age group (received FluAS25 or Fluarix) or in the 18- 40 years age group (received Fluarix). |
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E.4 | Principal exclusion criteria |
• Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination • Planned administration of an influenza vaccine other than the study vaccines during the entire study period • Any vaccination against influenza since January 2007 (with the 2006/2007 or the 2007/2008 influenza vaccine) • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • History of hypersensivity to a previous dose of influenza vaccine • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS25 (containing squalene, α- tocopherol, Tween 80 and MPL) • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests • 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) / Axillary temperature <37.5°C (99.5°F) • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period • Any medical conditions in which IM injections are contraindicated • Pregnant or lactating female, or planning to become pregnant or to discontinue contraceptive precautions. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence, intensity, duration and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination, in each group. • Occurrence, intensity, duration and relationship to vaccination of unsolicited AEs during a 21 day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination, 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 | 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 | No |
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 |
observer-blind for subjects ≥65 yrs, open for subjects 18-40yrs |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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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 |