healthy volunteers MedDRA version: 19.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: AdimFlu-S (QIS)
Product Code: AdimFlu-S (QIS)
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Current Sponsor code: A/CALIFORNIA/7/2009 (H1N1)PDM09 - DERIVED STRAIN U
Sponsors
Adimmune Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant females and aged =18 years; 2. Stable health status is defined by the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment; 3. Willing and able to adhere to visit schedules and all study requirements. If necessary, the burden of a site visit can be removed by a subject-centric approach. At investigators’ discretion, registered nurses and technology can be used in off-site facilities such as nursing home for subject recruitment, monitoring, and sample collection; 4. Subjects are willing to provide signed study-specific informed consent. 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 630 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1470
Exclusion criteria
Exclusion criteria: 1. Subjects received seasonal influenza vaccine within 6 months prior to study vaccination; 2. Clinically or virologically confirmed influenza infection within 6 months preceding the study start; 3. Any known or suspected allergy to any constituent of influenza vaccines (including but not limited to egg proteins) or a history of severe adverse reaction to a previous influenza vaccine; 4. Personal or family history of Guillain-Barré Syndrome; 5. Diagnosed coagulant function abnormality (e.g. clotting factor deficiency, clotting hemorrhagic disease, abnormal platelet function); 6. An acute febrile illness within 1 week prior to vaccination; 7. Subjects with influenza-like illness as defined by the presence of fever (temperature = 38.0°C). 8. Female subjects who are pregnant, lactating or likely to become pregnant during the study; also women of childbearing potential who disagree to use an acceptable method of contraception (e.g. hormonal contraceptives, IUD, barrier device or abstinence) throughout the study; 9. Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports; 10. Treatment with an investigational drug or device within 3 months prior to study vaccination; 11. Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection; 12. Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to = 20 mg/day of prednisone or equivalent for persons for > 2 weeks. Inhaled and topical steroids are allowed; 13. Receipt of live virus vaccine (both licensed and investigated) within 1 month prior to study vaccine or expected receipt within 1 month after study vaccination; receipt of any inactivated vaccine (both licensed and investigated) within 2 weeks prior to study vaccination or expected receipt within 1 month after study vaccination; 14. Receipt of any blood products, including immunoglobulin, within 3 months prior to study vaccination, which might interfere with assessment of the immune response; 15. Underlying condition which in the investigators’ opinion may interfere with evaluation of the study vaccine or prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to FluarixTetra in terms of GMT of HAI antibodies and seroconversion rates (SCRs) against the 4 virus strains at 21 days post-immunization on the whole study population (i.e. non-elderly and elderly subjects together);Secondary Objective: - To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to FluarixTetra in terms of GMT of HAI antibodies and SCR against the 4 virus strains at 21 days post-immunization according to 2 age categories (18-64 years old and =65 years old). - To describe the immunogenicity of AdimFlu-S (QIS) and FluarixTetra in terms of GMTs and SPR at Day 0, 21 and 180 and SCR and GMTR at Day 21 and 180 in overall and each age subgroup (non-elderly 18-64 years old and elderly =65 years old). - To demonstrate lot-to-lot consistency for AdimFlu-S (QIS) in terms of GMT of HAI antibody titers against the 4 vaccine strains at 21 days postimmunization. - To evaluate the short term reactogenicity and safety and long term safety after administration of AdimFlu-S (QIS) overall and in each age subgroup (non-elderly 18-64 years old and elderly =65 years old).;Primary end point(s): GMT of HAI antibodies and seroconversion rates (SCRs) against the 4 virus strains at 21 days post-immunization on the whole study population.;Timepoint(s) of evaluation of this end point: 21 days post-immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Demonstration of lot-to-lot consistency Immunogenicity of AdimFlu-S (QIS) and Fluarix Tetra in terms of HAI antibody titers: serum anti-hemagglutinin antibody against the four vaccine strains at baseline and 21 days and 180 days after vaccination expressed as these endpoints: - GMT at D0, D21 and D180; - Individual post (D21 or D180) - to pre (D0)-vaccination GMTRs; - SPR at D0, D21 and D180, seroprotection being defined as an HAI titer =1:40; - SCR at D21 and D180, seroconversion being defined as: *Either a pre-vaccination titer<1:10 and a post-vaccination titer =1:40, or *A pre-vaccination titer =1:10 and a =4-fold increase in post-vaccination titer. Description and comparison of immunogenicity of AdimFlu-S (QIS) and FluarixTetra in terms of VN or MN antibody titers at D0, D21 and D180 (30% of total subjects).;Timepoint(s) of evaluation of this end point: D21 and D180 | — |
Countries
Belgium, Taiwan
Contacts
Public ContactDr. Today Su
Adimmune Corporation
Outcome results
None listed