E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. |
|
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 | 10059430 |
|
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 evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in non-elderly adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines. |
|
E.2.2 | Secondary objectives of the trial |
Antibodies maybe additionally quantified using the hemagglutination inhibition (HI) test for confirmation purposes. (Note for Guidance on Harmonization of Requirements for Influenza Vaccines. CPMP/BWP/214/96: 12 March 1997) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males and females volunteers of 18 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; Individuals able to complain with all the study requirements; Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. |
|
E.4 | Principal exclusion criteria |
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject`s ability to participate in the study. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: Cancer, except for localized skin cancer; Advanced congestive heart failure; Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis); Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; Severe asthma Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); Individuals with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease; Individuals with known or suspected history of drug or alcohol abuse Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator s opinion would interfere with the safety of the subject Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing potential do not plan to use acceptable birth control measures, for the whole duration of the study. 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 (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject s study entry Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. Individuals Within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine; Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days Individuals that have experienced fever (i.e., axillary temperature ≥ 38C) within the last 3 days of intended study vaccination Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study Individuals participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study. Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within 4 weeks from the study vaccines Individuals who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks and for the full length of the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity Endpoints The following serological assessments should be considered for each strain in non-elderly adult subjects, aged between 18 and 60, and at least one of the assessments should meet the indicated requirements: The proportion of subjects achieving seroconversion or significant increase in anti-HA antibody titer should be > 40% Mean geometric increase should be > 2.5 The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 70% The following serological assessments should be considered for each strain in elderly subjects, aged over 60, and at least one of the assessments should meet the indicated requirements: The proportion of subjects achieving seroconversion1 or significant increase in anti-HA antibody titer should be > 30% Mean geometric increase should be > 2.0 The proportion of subjects achieving an HI titer ≥ 40 or SRH area ≥ 25 mm2 should be > 60% If SRH assays: Seroconversion is defined as negative pre-vaccination serum / post-vaccination serum: area ≥25mm2: Significant increase as at least a 50% increase in antibody If HI assays: Seroconversion is defined as negative pre-vaccination serum / post-vaccination serum titre ≥1:40: Significant increase as at least a 4-fold increase in antibody titre (CPMP/BWP/214/96: 12 March 1997 Safety Endpoints Safety will be assessed in accordance with available safety data on influenza vaccines. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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) | 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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 21 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 | 21 |