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 65 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 demonstrate in adults aged 65 years and above, the superior efficacy of the FLU NG vaccine in the prevention of RT-PCR confirmed influenza A and /or B, for any influenza strain, when compared to Fluarix™. To demonstrate the lot-to-lot consistency of 3 lots of the FLU NG vaccine in terms of immunogenicity (as measured by GMT), 21 days after vaccination. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of FLU NG vaccine in the prevention of culture confirmed influenza (A, B) vs Fluarix for any strain, for vaccine matching and unmatching strains. During each flu peak season, to evaluate the efficacy of FLU NG vaccine vs Fluarix™ in the prevention of: (hospitalization due to) pneumonia, clinical flu or acute CHF; MI or stroke; all-cause death; hospitalization due to respiratory diseases. During each flu peak season, the incidence of pneumonia, acute CHF, MI and stroke in both groups. To evaluate immunogenicity (21 & 180 d) after each vaccination in a subset. To evaluate safety/reactogenicity in a subset: solicited AEs (7 d), AEs (21 d), AEs with medically attended visit (180 d) after each vaccination. To evaluate safety: SAEs and AEs of specific interest during the entire study period. In case of additional subjects the 2nd year: to evaluate safety of the first dose of both vaccines: SAEs and AEs of specific interest 12 mo after first vaccination in all.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. return for follow-up visits, disease reporting by phone, and completion of questionnaires) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse. • A man or woman aged 65 years or older at the time of the vaccination. • Written informed consent obtained from the subject. • Subjects with residence status allowing free mixing with general community.
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E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • Bedridden subjects • Previous vaccination against influenza since February 2008. • Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine. • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. • Any contra-indication to intramuscular administration of the influenza vaccines. • History of hypersensitivity to a previous dose of influenza vaccine. • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence of RT-PCR confirmed influenza A and/or B infection, for any influenza strain. • At days 0 and 21, serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine strains, in the FLU NG groups. |
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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 | Yes |
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 | Yes |
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 | 212 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |