| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 61 years or above. |
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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 whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response that meets or exceeds the EMEA (CHMP) guidance targets for pandemic influenza vaccines (seroconversion rate (SCR), seroprotection rate (SPR), and seroconversion factor (SCF)) at 21 days after the second dose of H1N1 vaccine when Fluarix™ has been administered or not at least 21 days before in subjects aged 61 years and older. |
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| E.2.2 | Secondary objectives of the trial |
To assess whether vaccination with one dose of Fluarix™ results in an HI immune response that meets or exceeds for each vaccine strain at least one of the EMEA guidance targets for seasonal influenza vaccines at 21 days after vaccination when administered before or after the H1N1 candidate vaccine.
To assess in terms of GMT ratio the HI antibody response 21 days after the second H1N1 candidate vaccine dose/Fluarix™, when given 21 days after Fluarix™ /H1N1 candidate vaccine as compared to the immunogenicity of the same H1N1 candidate vaccine/Fluarix™ in the absence of Fluarix™/H1N1 candidate vaccine.
To assess the immunogenicity of the H1N1 candidate vaccine in terms of HI antibody response 6 months and 12 months after vaccination in each study group.
To evaluate the safety/reactogenicity in terms of solicited local and general AEs during a 7-Day follow-up period, unsolicited adverse events during 21 days after each vaccination and SAEs and AESIs during the entire study period.
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Male or female subjects 61 years of age or older at the time of the first vaccination.
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits).
Written informed consent obtained from the subject.
Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
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| E.4 | Principal exclusion criteria |
Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere influenza vaccine.
Previous administration of a pandemic influenza vaccine.
Administration of any vaccine within 30 days before first vaccination.
Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with the A/California/7/2009 (H1N1)v-like candidate vaccine.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator’s judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Presence of an axillary temperature >= 37.5°C, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
Diagnosed with cancer, or treatment for cancer, within 3 years.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are eligible and may be enrolled within 3 years of diagnosis, but other histological types of skin cancer require a 3-year untreated and disease-free window as above.
Women who are disease free for 3 years or more after the treatment of breast cancer and receiving long-term prophylactic tamoxifen are eligible and may be enrolled.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination and during the entire study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone when administered for more then 2 weeks. Inhaled and topical steroids are allowed.
Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
An acute evolving neurological disorder or history of Guillain-Barré syndrome.
Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases).
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
History of chronic alcohol consumption and/or drug abuse.
Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Humoral immune response in terms of HI antibodies.
Observed variable (with 95% CI for each study group):
HI antibodies against the vaccine-strain at Day 42.
Derived variables (with 95% CI for each study group):
GMTs and seropositivity rates of HI antibody titres at Day 42.
SCR at Day 42.
SCF at Day 42.
SPR at Day 42.
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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) | 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 | Yes |
| 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 | Yes |
| 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 | 6 |
| 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 | 1 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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