E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 19.0 |
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 |
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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 |
(1) Cellular Immunogenicity - To evaluate the cellular immune responses based on multi-parametric FACS analysis in all subjects at 0 and 42 and 180 days following FLU-v vaccination. - To evaluate the cellular immune responses based on IFN-γ ELISA assays in all subjects at 0 and 42 and 180 days following FLU-v vaccination.
(2) Safety - To evaluate the solicited AEs in all subjects until 21 days after the last dosing of the study vaccine (FLU-v). - To evaluate the unsolicited AEs and SAEs in all subjects during the whole study period.
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E.2.2 | Secondary objectives of the trial |
- To evaluate the antibody responses in all subjects at 0, 42 and 180 days following FLU-v vaccination. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Healthy males or healthy non-pregnant females (as indicated by a negative blood pregnancy test done during the screening visit) between the ages of 18 and 60 years, inclusive; - Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice appropriate contraception (a combination of barrier and hormonal methods for women and a condom for men) from screening and until at least 30 days (up to Study Day 51 for females) and 90 days (up to Study Day 111 for males), after the last vaccination. - A subject is in good health, as determined by a comprehensive clinical assessment {vital signs (heart rate, blood pressure, oral temperature)}, blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness} and the clinical judgment of the investigator; - Able to understand and comply with planned study procedures; - Provides signed informed consent form
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E.4 | Principal exclusion criteria |
- Has a known allergy to any of the components of the vaccine. - Has a history of severe reaction following immunization. - Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy. - Women who have a positive pregnancy test during the screening visit or who are breastfeeding. - Has a history of any of the following (reported by subjects): o Acute disseminated encephalomyelitis (ADEM); o Neoplastic disease – current or previous; o Asthma or severe allergic disease; o Bleeding disorders o Chronic Hepatitis B and/or C infection; o Chronic liver disease; o Diabetes mellitus; o Guillain-Barré syndrome; o HIV; o Rheumatoid arthritis or other autoimmune diseases; o Severe renal disease; o Transplant recipients; o Unstable or progressive neurological disorders. - Receipt of medicines/treatments that may affect evaluation of immunogenicity such as: o Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (azathioprine (Imuran), cyclosporine (Neoral, Sandimmune, SangCya); monoclonal antibodies such as basiliximab (Simulect), daclizumab (Zinbryta), infliximab (Remicade), rituximab (MabThera), alemtuzumab (Campath and Lemtrada), omalizumab (Xolair), abatacept (Orencia), adalimumab (Humira and Exemptia) and etanercept (Enbrel)basiliximab (Simulect), daclizumab (Zenapax), and muromonab (Orthoclone OKT3); corticosteroids such as prednisone (Deltasone, Orasone); tacrolimus (Prograf, Advagraf, Protopic); Glatiramer acetate (Copaxone); Mycopehnolate (Cellcept); Sirolimus (Rapamune); (within 6 months of vaccination in this study) o Immunoglobulin or other blood products (within 3 months of vaccination in this study); o An experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month of vaccination in this study, or expects to receive an experimental agent (during the study period). o Influenza antiviral medication (within 4 weeks of vaccination in this study). - Has received any influenza vaccine within 6 months of vaccination in this study - Has influenza-like illness (a sudden onset of symptoms and at least one of the four systemic symptoms-fever or feverishness, malaise, headache, myalgia and at least one of the three respiratory symptoms-cough, sore throat, shortness of breath) or acute respiratory infection (a sudden onset of symptoms and at least one of the four respiratory symptoms-cough, sore throat, shortness of breath, coryza (Rhinitis) and a clinician’s judgement that the illness is due to an infection) within 6 months prior to vaccination in this study. These symptoms must have stopped the subject from carrying out their normal daily activities such as attending work or school for a period of at least 3 days. - Has an acute illness, including an oral temperature greater than 38 degrees Celsius, within 1 week of vaccination. - Has a history of alcohol or drug abuse within the last 2 years deemed unsuitable for inclusion by the investigator. - Any abnormal haematology values and/or serum chemistries judged by the Investigator as clinically significant. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity: Cellular immune responses in all subjects at 0, 42 and 180 days following FLU-v vaccination.
Safety: Evaluation of the solicited AEs in all subjects until 21 days after the last dosing of study vaccine (FLU-v). Evaluation of the unsolicited AEs and SAEs in all subjects during the whole study period.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity: Cellular immune responses in all subjects at 0, 42 and 180 days following FLU-v vaccination.
Safety: Evaluation of the solicited AEs in all subjects until 21 days after the last dosing of study vaccine (FLU-v). Evaluation of the unsolicited AEs and SAEs in all subjects during the whole study period. |
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E.5.2 | Secondary end point(s) |
To evaluate the humoral immune responses in all subjects at 0, 42 and 180 days following FLU-v vaccination. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
To evaluate the humoral immune responses in all subjects at 0, 42 and 180 days following FLU-v 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) | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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
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End of the trial is September 2017 as defined in the protocol. The total study time is a maximum 1 year from first subject first visit to study conclusion. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |