Influenza A and/or B MedDRA version: 19.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: FLU-v
Product Code: FLU-v
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: FLU-5
Other descriptive name: FLU-5
Concentration unit: µg microgram(s)
Concentrat
Sponsors
PepTcell Limited (trading as SEEK)
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 222 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To evaluate the antibody responses in all subjects at 0, 42 and 180 days following FLU-v vaccination.;Main Objective: (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-? 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. ;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. ;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the humoral immune responses in all subjects at 0, 42 and 180 days following FLU-v vaccination. ;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. | — |
Countries
Netherlands
Contacts
Public ContactClinical trials information
PepTcell Limited (trading as SEEK)
Outcome results
None listed