E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
H5N1 Influenza vaccination in healthy subjects |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
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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 immune response to an H5N1 influenza vaccine in an adult and elderly population; To assess the safety and tolerability of an H5N1 influenza vaccine in an adult and elderly population; To assess the need for and timing of a booster vaccination. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the T-cell mediated immune response induced by an H5N1 influenza vaccine after the first, second and booster vaccinations. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
For a subset of subjects further objectives of the study are:· To evaluate the T-cell mediated immune response induced by an H5N1 influenza vaccine after the first, second and booster vaccinations. |
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E.3 | Principal inclusion criteria |
Male and female subjects will be eligible for participation in this study if they:·
Are 18 to 59 years of age on the day of screening (for Stratum A only); · Are 60 years of age and older on the day of screening (for Stratum B only); Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry; Are clinically healthy (in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical study);· Agree to keep a daily record of symptoms;· If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study |
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E.4 | Principal exclusion criteria |
Subjects will be excluded from participation in this study if they:· Have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine;· Are at high risk of contracting H5N1 influenza infection (e.g. poultry workers);· Suffer from or have a history of a significant cardiovascular, pulmonary, neurological, hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder;· Are unable to lead an independent life as a result of either physical or mental handicap; Suffer from any kind of immunodeficiency; Suffer from a disease or were undergoing a treatment within 30 days prior to study entry or are currently undergoing a form of treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs; Have a history of severe allergic reactions or anaphylaxis; Have a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating; Have received a blood transfusion or immunoglobulins within 90 days of study entry; Have donated blood or plasma within 30 days of study entry; Have received any live vaccine within 4 weeks or inactivated vaccine within 2 weeks prior to vaccination in this study;· Have a functional or surgical asplenia; Have a known or suspected problem with alcohol or drug abuse; Were administered an investigational drug within six weeks prior to study entry or are concurrently participating in a clinical study that includes the administration of an investigational product; Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator; |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity:· Number of subjects with antibody response to the vaccine strain (A/Vietnam/1203/2004) associated with protection 21 days after the second vaccination defined as titer measured by Microneutralization (MN) test greater or equal to 20.
Please note that in response to CHMP Scientific Advice, SRH testing has now been inlcuded as a secondary endpoint.
Safety:· Number of subjects with systemic reactions after the first vaccination.
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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 | No |
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 | No |
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 | No |
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
| 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | 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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Part A_completed when all subjects (=subj.) have finished Day21. Part B_completed when all subj. who receive a 6-mo booster have finished the Day21. Part C_completed when all subj. who receive a 12-mo booster have finished Day21. Part D_completed when all subj. who receive a 24-mo booster have finished Day21 post booster visit. Part E_a separate report will be generated for the evaluation of cellular immunity. Part F_completed when subj. who received a 24-mo booster had Visit11. |
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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 | 29 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 29 |