Clinical Trials List
Protocol NumberAdim-QIS-01
NCT Number(ClinicalTrials.gov Identfier)N/A
Not yet recruiting
2016-11-01 - 2017-12-31
Phase III
Terminated2
ICD-10J10.1
Influenza due to other identified influenza virus with other respiratory manifestations
A Phase III, Multi-center, Single Dose, Randomized, Double-blind, Non-inferiority and Lot-to-lot Consistency Study of Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) versus Fluarix Tetra Vaccine in Healthy Subjects
-
Trial Applicant
Clinipace Taiwan Co., Ltd
-
Sponsor
Adimmune Corporation
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/04/01
Investigators and Locations
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Influenza
Objectives
Primary objectives:
To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to Fluarix Tetra 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 objectives:
- To demonstrate the immunological non-inferiority of AdimFlu-S (QIS) compared to Fluarix Tetra 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 Fluarix Tetra 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 post-immunization
- 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).
- To evaluate the humoral immune response induced by the study vaccines in terms of neutralizing antibody (VN or MN assays) titers at Day 0, 21 and 180 in a subset of subjects (30% subgroup).
Test Drug
AdimFlu-S (QIS)
Active Ingredient
4 strains antibody
Dosage Form
0.5 mL sterile suspension containing 4 strains
Dosage
15mg/ 0.5 mL sterile suspension containing 4 strains
Endpoints
Primary endpoints:
The subjects receiving AdimFlu-S (QIS) vaccine will be pooled and compared with Fluarix Tetra group.
• PP population.
• Adjusted GMTs estimated using ANCOVA model filled on the log10 post vaccination titers including treatment, age group, and country as fixed effects and pre-vaccination titers as the co-variate.
• 2-sided 95% CI of the differences of the adjusted means of the log10 post-vaccination titers (FluarixTetra – AdimFlu-S (QIS)) will be computed from the above model.
• GMTRs (with two-sided 95% CI) with AdimFlu-S (QIS) as numerator and Fluarix Tetra as denominator will be computed by taking the anti-log10 of the difference in adjusted means and of the lower and upper limits of its 95% CI.
• If the upper limit of the two-sided 95% CI on the GMTRs does not exceed 3/2 (or, equivalently, if the upper limit of the two-sided 95% CI on the log10 titers mean difference does not exceed 0.176) for a given strain, the non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra in terms of GMT of HAI antibodies will be concluded for that specific strain.
• The global non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra in terms of GMT of HAI antibodies will be concluded if the 95% CI of all the four strains meet the non-inferiority criteria simultaneously.
• For the non-inferiority analysis on SCR, the upper limit of two-sided 95% CI of the difference (FluarixTetra minus AdimFlu-S (QIS)) does not exceed 10% for that specific strain.
• The global non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra on SCR will be concluded if the 95% CI of all the four strains meet the non-inferiority criteria simultaneously.
• The overall non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra on immunogenicity will be demonstrated when global non-inferiority on GMTs and SCRs are both concluded.
The subjects receiving AdimFlu-S (QIS) vaccine will be pooled and compared with Fluarix Tetra group.
• PP population.
• Adjusted GMTs estimated using ANCOVA model filled on the log10 post vaccination titers including treatment, age group, and country as fixed effects and pre-vaccination titers as the co-variate.
• 2-sided 95% CI of the differences of the adjusted means of the log10 post-vaccination titers (FluarixTetra – AdimFlu-S (QIS)) will be computed from the above model.
• GMTRs (with two-sided 95% CI) with AdimFlu-S (QIS) as numerator and Fluarix Tetra as denominator will be computed by taking the anti-log10 of the difference in adjusted means and of the lower and upper limits of its 95% CI.
• If the upper limit of the two-sided 95% CI on the GMTRs does not exceed 3/2 (or, equivalently, if the upper limit of the two-sided 95% CI on the log10 titers mean difference does not exceed 0.176) for a given strain, the non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra in terms of GMT of HAI antibodies will be concluded for that specific strain.
• The global non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra in terms of GMT of HAI antibodies will be concluded if the 95% CI of all the four strains meet the non-inferiority criteria simultaneously.
• For the non-inferiority analysis on SCR, the upper limit of two-sided 95% CI of the difference (FluarixTetra minus AdimFlu-S (QIS)) does not exceed 10% for that specific strain.
• The global non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra on SCR will be concluded if the 95% CI of all the four strains meet the non-inferiority criteria simultaneously.
• The overall non-inferiority of AdimFlu-S (QIS) over Fluarix Tetra on immunogenicity will be demonstrated when global non-inferiority on GMTs and SCRs are both concluded.
Inclution 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.
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.
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.
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.
The Estimated Number of Participants
-
Taiwan
1050 participants
-
Global
2100 participants
