| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | |
| E.1.1.1 | Medical condition in easily understood language | |
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 18.1 | | E.1.2 | Level | PT | | E.1.2 | Classification code | 10022000 | | E.1.2 | Term | Influenza | | E.1.2 | System Organ Class | 10021881 - Infections and infestations | |
| 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 | Immunogenicity Objective
To compare the immunogenicity of a single intramuscular (IM) injection of FLUAD™ (FLUAD) vs. inactivated subunit virus influenza vaccine, with regards to A/H3N2 antigen, when administered to adult subjects with underlying chronic disease(s), as measured by Hemagglutination Inhibition (HI) test at day 22.
Safety Objective
To evaluate the safety of a single IM injection of the two influenza vaccines, when administered to adult subjects with underlying chronic disease(s). | |
| E.2.2 | Secondary objectives of the trial | • To compare the immunogenicity of a single IM injection of FLUAD vs. inactivated subunit virus influenza vaccine, with regards to B antigen, when administered to adult subjects with underlying chronic disease(s), as measured by HI test at day 22.
• To evaluate the immunogenicity of a single IM injection of FLUAD vs. inactivated subunit virus influenza vaccine, with regards to A/H1N1 antigen, when administered to adult subjects with underlying chronic disease(s), as measured by HI test at day 22. | |
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria | 1. 18 to 60 years of age adult volunteers, mentally competent, willing and able to give written informed consent prior to study entry;
2. able to comply with all the study requirements;
3. suffering from at least one of these chronic diseases:
• moderate to severe hypertension
• moderate to severe congestive heart failure
• COPD or moderate to severe asthma
• moderate to severe hepatic or renal insufficiency
• arteriosclerotic disease or insulin dependent diabetes mellitus
| |
| E.4 | Principal exclusion criteria | 1. hypersensitivity to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine;
2. history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
3. 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 cortical steroid or cancer chemotherapy/radiotherapy) within 60 days prior to enrollment and for the full length of the study;
• receipt of immunostimulants;
• receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within 3 months prior to enrollment and for the full length of the study;
• suspected or known HIV infection or HIV-related disease;
4. known or suspected history of drug or alcohol abuse;
5. women who were pregnant, or women able to bear children but not willing to practice acceptable contraception for the first 3 weeks of the duration of the trial;
6. within the 12 months prior to enrollment, the individual had:
• received more than one injection of influenza vaccine;
7. within the 6 months prior to enrollment, the individual had:
• laboratory confirmed influenza disease;
• received influenza vaccine;
8. within the 4 weeks prior to enrollment the individual had received:
• another vaccine;
• any investigational agent;
9. within the 7 days prior to enrollment, the individual had experienced:
• any acute disease;
• infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable);
10. had experienced an acute exacerbation of a COPD within the 14 days prior to enrollment;
11. within the 3 days prior to enrollment, individuals had experienced:
• fever (i.e., body temperature ≥ 38°C);
12. were taking part in another clinical study;
13. had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective. | |
| E.5 End points |
| E.5.1 | Primary end point(s) | Immunogenicity
The immunogenicity of the two vaccines was evaluated considering the following measurements according to the CPMP/BWP/214/96 guideline:
• percentage of seroconversions or significant increase (seroconversion rate) in HI antibody titer
• mean geometric increase (i.e., GMR) in HI antibody and ratio of postvaccination GMTs between vaccines
• percentage of subjects achieving an HI titer ≥40 (seroprotection)
Safety
Number of subjects with reported local and systemic reactions as well as the number of subjects with reported SAEs and/or AEs per vaccination group.
Local reactions included: ecchymosis, erythema, induration, swelling, and pain at injection site.
Systemic reactions included: chills, malaise, myalgia, arthralgia, headache, sweating, fatigue and fever (derived from axillary temperature ≥38°C). | |
| E.5.1.1 | Timepoint(s) of evaluation of this end point | • Immunogenicity 21 days after vaccination
• AEs will be assessed for 6 days post the day of vaccination
• All adverse events (AEs) necessitating a physician’s visit or consultation and/or leading to premature study discontinuation will be collected for 3 weeks following vaccination.
• All serious adverse events (SAEs) will be collected during a 6 months follow-up, i.e., until day 181 (window: day 177- day 185). | |
| E.5.2 | Secondary end point(s) | |
| E.5.2.1 | Timepoint(s) of evaluation of this end point | |
| 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 | 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 | |
| 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 | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description | |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | No |
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
