E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunization against influenza in male and female subjects aged 19-43 years and 66 years or older. |
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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 the safety and reactogenicity during the entire study period in subjects aged 66 years or older (previously enrolled in the 111737 study) vaccinated with the FLU NG vaccine or with Fluarix, and in subjects aged 19-43 years (previously enrolled in the 111737 study) vaccinated with Fluarix |
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E.2.2 | Secondary objectives of the trial |
•To assess the humoral immunogenicity 21 days following vaccination in subjects aged 66 years or older (previously enrolled in the 111737 study) vaccinated with the FLU NG vaccine or with Fluarix, and in subjects aged 19-43 years (previously enrolled in the 111737 study) vaccinated with Fluarix. •To evaluate the persistence of haemagglutination-inhibition (HI) antibodies 180 days after vaccination in each group. •To evaluate the Cell-Mediated Immune (CMI) response at Days 0, 21 and 180, in a sub-cohort of subjects, in each group. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•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, reporting by phone) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse. •A male or female aged 19-43 years or 66 years or older at the time of the vaccination and who participated in the 111737 study and completed the 6-month follow-up. •Written informed consent obtained from the subject. •Free of an acute aggravation of the health status as established by clinical evaluation (medical history and 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 pre-menarche, 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 for 2 months after the vaccination.
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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(s) within 30 days prior to vaccination, or planned use during the study period. •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 an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period. •Vaccination against influenza since January 2009 with a seasonal influenza vaccine. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >/=20 mg/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). •Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation (medical history and physical examination) or pre-existing laboratory screening tests. •Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥37.5°C on oral setting. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study. •Any medical conditions in which IM injections are contraindicated •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Solicited local and general symptoms Occurrence, intensity and duration of solicited local AEs during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination. Occurrence, intensity, duration and relationship to vaccination of solicited general AEs during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination. •Unsolicited adverse events Occurrence, intensity 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. •Predefined adverse events Occurrence, intensity and relationship to vaccination of AEs with medically attended visit during a 180-day follow-up period (i.e. day of vaccination and 179 subsequent days) after vaccination. Occurrence, intensity and relationship to vaccination of AEs of specific interest during the entire study period. Serious adverse events Occurrence and relationship to vaccination of SAEs during the entire study period. |
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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 |
reactogenicity, immunogenicity |
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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 | 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 66+; open 19-43yrs; randomized in primary study revaccinated with same vaccine |
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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 | 25 |
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 | 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 |