E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Re-vaccination against influenza in male and female subjects aged 18-60 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 assess during the entire study period (30 days) the safety and reactogenicity of re-vaccination with the low dose influenza vaccine adjuvanted with half dose of AS03. Fluarix™ will be used as reference |
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E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity (GMT, seroconversion factor, seroconversion and seroprotection rates) 21 days following re-vaccination with the low dose influenza vaccine, adjuvanted with half dose of AS03. Fluarix™ will be used as reference. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• A male or female aged 18-60 years old at the time of vaccination, who previously received either the low dose influenza vaccine adjuvanted with AS03 (whatever the adjuvant dose), or Fluarix during the FLU-LD-004 clinical trial. • 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. • Written informed consent obtained from the subject. • Free of obvious health problems 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. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
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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. • Planned administration of an influenza vaccine other than the study vaccines during the entire study period • Previous vaccination against influenza since January 2007. • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three 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). • Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period. • History of hypersensivity to a previous dose of influenza vaccine. • History of confirmed influenza infection within the last 12 months. • Pregnancy. • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate and adjuvant AS03 (containing squalene, alpha-tocopherol and Tween 80). • 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 diarrhea, 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)).
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence, intensity and relationship to re-vaccination of solicited local and general signs and symptoms during a 7-day follow-up period (i.e. day of re-vaccination and 6 subsequent days) after re-vaccination in each group. • Occurrence, intensity and relationship to re-vaccination of unsolicited AEs during a 30-day follow-up period (i.e. day of re-vaccination and 29 subsequent days) after re-vaccination in each group. • Occurrence and relationship to re-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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | 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.8.3 |
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.8.5 | 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 | 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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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 | |
E.8.9.1 | In the Member State concerned days | 58 |
E.8.9.2 | In all countries concerned by the trial days | 58 |