E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | HLT |
E.1.2 | Classification code | 10022005 |
E.1.2 | Term | Influenza viral infections |
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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 determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2008/2009, in two groups: - Adult subjects aged ≥ 18 and ≤ 60 years. - Elderly subjects ≥ 61 years of age.
Safety Objective: To collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Influvac®. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. 3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination). |
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E.4 | Principal exclusion criteria |
1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. A serious adverse reaction after a previous (influenza) vaccination. 3. Presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period. 5. A history of Guillain-Barré syndrome or active neurological disease. 6. Having fever and/or presenting with an acute disease or infection at the day of study vaccination. 7. Having any condition affecting the immune system e.g. autoimmune disease. 8. Receipt of vaccines (live or inactivated) other than study vaccine within four weeks before study vaccination or planned vaccination during the study period. 9. Using or having used medication that influences the immune system (such as corticosteroids) during the four weeks prior to the study and planned use thereof during the study. Topical use of corticosteroids (e.g. cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed. 10. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within the preceding 36 months before the day of study vaccination. 11. Receipt of another investigational agent within 30 days prior to study vaccination, or planned use during the study period. 12. Known drug or alcohol abuse 13. Planned surgery during the study period.
Exclusion criteria only for female subjects aged ≥ 18 and ≤ 60 years and of childbearing potential:
14. Being pregnant (positive urine pregnancy test at the day of study vaccination), breastfeeding or a desire to become pregnant during the study. 15. Not using a medically accepted method of birth control including abstinence during the study period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity is a well-correlated and long time accepted surrogate parameter for clinical effectiveness of influenza vaccines. Therefore, the primary efficacy variable will be HI titers and its derived parameters as defined by the CHMP guideline for influenza vaccines.
The following serological parameters will be derived from the individual HI antibody titers, separately for each strain: - the pre-and post-vaccination seroprotection rates, with seroprotection defined as an HI titer ≥ 40 - the seroconversion rate, with seroconversion defined as a pre-vaccination HI titer < 10 and a post-vaccination HI titer ≥ 40 - the proportion of subjects with at least a 4-fold increase in HI titer, i.e. the proportion of subjects with a pre-vaccination HI titer ≥ 10 and a post-vaccination relative increase of ≥ 4-fold - the proportion of subjects with seroconversion or at least a 4-fold increase in HI titer - the mean fold increase, which is the geometric mean of the intra-individual increases (i.e. post-vaccination HI titer / pre-vaccination HI titer).
The results of the serological analysis will be evaluated according to the CHMP Note for Guidance which requires that for both age groups at least one of the following criteria is met for each of the three strains:
Criterion Adults Elderly
Seroprotection rate: > 70% > 60% Seroconversion / 4-fold increase rate: > 40% > 30% Mean fold increase: > 2.5 > 2.0 |
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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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 1 |