| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| 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 |
This study focuses on pre-pandemic priming of man against H5 influenza with the goal of mounting a robust antibody response to small quantities of vaccine either before or during an H5 pandemic.
The purpose of the study is to examine the height, breadth (i.e., cross-protective antibosy responses), and persistence of the antibody response to a prime-boost vaccination strategy, and establish whether the response after boosting depnds on whether the booster is adjuvanted or not.
The ultimate goal of this work is to provide crucial infromation on the use of pre-pandemic vaccines in priming and protecting the population from pandemic influenza, specifically paying attention to ways in which the least amount of antigen can immunise the largest number of people. |
|
| E.2.2 | Secondary objectives of the trial |
To evaluate the magnitude of the antibody responses to one or two ‘priming’ 0.5mL intramuscular (IM) doses of an MF59-adjuvanted A/Vietnam/1194/2004 influenza vaccine in immunologically naïve subjects;
To examine the kinetics, magnitude, breadth, and persistence of the antibody responses to one 0.5mL ‘booster’ intramuscular dose of antigenically drifted MF59-adjuvanted vaccine, or non-adjuvanted antigenically drifted vaccine, given at doses of 3.75 or 7.5μg, in subjects primed with one or two doses of an MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine;
To evaluate the safety of the administration of the above vaccines. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Inclusion criteria
1. Subjects 18 to 59 years of age, or 60 years of age and older, mentally
competent, who have signed an informed consent form after having received a
detailed explanation of the study protocol;
2. Are in good health or have one or more stable (See footnote) medical conditions,
as determined by:
a. Medical history,
b. Physical examination,
c. Clinical judgment of the medical investigator;
3. Are able to understand and comply with all study procedures and to complete
study diaries, can be contacted, and will be available for study visits.
|
|
| E.4 | Principal exclusion criteria |
Exclusion criteria
1. Receipt of another investigational agent within 3 months, or before completion of
the safety follow-up period in another study, whichever is longer, prior to
enrollment and unwilling to refuse participation in another clinical study through
the end of the study;
2. Subjects who experienced any acute disease or infection requiring systemic
antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract
prophylaxis is acceptable) during the 7 days preceding vaccination;
3. Subjects who experienced fever (defined as axillary temperature >=38C) within 3
days prior to Visit 1;
4. Subjects who are pregnant or breastfeeding;
5. Females of childbearing potential who refuse to use an acceptable method of
birth control for a period of 56 days before and after each vaccination. Adequate
contraception is defined as hormonal (e.g., oral, injection, transdermal patch,
implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with
spermicide), intrauterine device (e.g., IUD), monogamous relationship with
vasectomised partner who has been vasectomised for 6 months or more prior to
the subject’s study entry, or abstain from heterosexual intercourse (e.g., through
sexual orientation or religious or other beliefs about premarital intercourse);
6. Subjects with any serious disease, including:
a. cancer,
b. acute or progressive hepatic disease,
c. acute or progressive renal disease,
d. chronic pulmonary disease requiring home oxygen therapy,
e. active neurological disorder,
f. autoimmune disease (including rheumatoid arthritis);
7. Subjects for whom surgery is planned during the study period;
8. Subjects with a bleeding diathesis;
9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers,
influenza viral protein, neomycin or polymixin, or any other component of the
study vaccine;
10.Subjects with a history of any neurological symptoms and signs, or anaphylactic
shock following administration of any vaccine;
11. Subjects with known or suspected impairment/alteration of immune function, for
example, resulting from:
a. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or
cancer chemotherapy) (long-term, inhaled steroids for asthma management is
acceptable),
b. receipt of immunostimulants or interferon,
c. receipt of parenteral immunoglobulin preparation, blood products, and/or
plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5
(Day 382), or planned during the full length of the study,
d. high risk from developing an immunocompromising disease;
12. Actual or planned receipt of another vaccine during the period 3 weeks before
to 3 weeks after vaccination on Days 1, 22, and 382;
13. Subjects with a history of (or current) drug or alcohol abuse (20g/day for
females; 30g/day for males) that in the investigator’s opinion would interfere
with safety of the subject or the evaluation of the study objectives;
14. Subjects who are unable to lead an independent life either physically or
mentally;
15. Have participated in a previous study of H5 avian influenza vaccine;
16. Have been previously vaccinated with a vaccine containing MF59 or similar
adjuvant;
17. Subjects with any condition, which, in the opinion of the Investigator, might
interfere with the evaluation of the study objectives.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Antibody response and persistence after primary and booster immunizations |
|
| 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 | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Information not present in EudraCT |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| 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 | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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) | No |
| 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
|
| The end of the trial corresponds to the last visit of the last subject undergoing the trial |
|
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | |
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