Clinical Trials List
Protocol NumberV118_24
NCT Number(ClinicalTrials.gov Identfier)NCT06087640
2023-09-01 - 2026-06-30
Phase III
Not yet recruiting4
Recruiting1
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine Compared to a Quadrivalent Influenza Vaccine in Adults ≥65 Years of Age
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Hsiang-Han Kao 無
- Po-Tsung Huang 無
- 陳宗伯 無
- 吳美鳳 無
- 賴冠宇 無
- Chih Hsueh Lin 無
- Chiu-Shong Liu 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Mei-Hui Lee 無
- 徐于涵 無
- 廖乙學 無
- 林聖閎 無
- Yung-Ching Liu 無
- 陳信儒 無
- 彭邦中 無
- Kuan-Yuan Chen 無
- 林姿吟 無
- 周碩渠 無
- 劉家鴻 無
- 李思翰 無
- 謝蔡豪 無
- Wei-Hong Cheng 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ying-Chin Lin 無
- Kuan-Jen Bai 無
- Jer-Hwa Chang 無
- 江振源 無
- Tsong-Yih Ou 無
- Shian-Jiun Lin 無
- Ying-Shih Su 無
- Chih-Hsin Lee 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Pai-Chien Chou 無
- Shih-Hsin Hsiao 無
- Hsin-Yi Liu 無
- CHIEN-CHIH WU 無
- 莊涵琄 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Influenza, Human
Objectives
Main therapeutic purposes:
1a. Confirm that aQIV is non-inferior to QIV in preventing influenza A and/or influenza B illness in adults aged 65 years due to any influenza strain and confirmed by reverse transcription polymerization chain reaction (RT-PCR) Vaccine reference materials.
Success Benchmarks for Non-Inferiority:
The efficacy of aQIV compared to the QIV control is confirmed if the interim analysis (IA) of relative vaccine efficacy (rVE) with an adjusted two-tailed 95%* confidence interval (CI) lower limit (LL) is greater than or equal to -20% For non-inferiority.
1b. Confirm that aQIV is more effective than QIV influenza vaccine reference products in preventing influenza A and/or influenza B disease in adults aged 65 years and older who are infected by any influenza virus strain and confirmed by RT-PCR.
Effectiveness Success Benchmarks:
If the LL of the adjusted two-tailed 95%* CI of IA for rVE is greater than 0%, superiority of the efficacy of aQIV relative to the QIV comparator is confirmed.
The trial will be considered successful if objective 1a is confirmed using the influenza-like illness (ILI) definition defined in the trial protocol.
Secondary therapeutic objectives:
1. Evaluate aQIV compared to QIV for prophylactic antigens compared to virus strains selected for seasonal vaccines
Efficacy of influenza A and/or influenza B caused by qualified influenza virus strains, using the ILI definition defined in the proposal.
2. Evaluate the efficacy of aQIV compared to QIV in preventing culture-confirmed influenza A and/or influenza B disease due to any strain (regardless of whether the antigen is consistent with the strain selected for seasonal vaccines), and use the plan Book definition of ILI definition.
3. Evaluate the non-inferiority and superiority of aQIV compared to QIV in preventing influenza A and/or influenza B disease confirmed by RT-PCR for any influenza strain, using the adjusted U.S. Disease Control and Prevention Centers for Disease Control and Prevention (CDC) ILI definition and the World Health Organization (WHO) ILI definition.
4. Evaluate the efficacy of aQIV compared to QIV in preventing influenza A and/or influenza B caused by influenza strains that are antigenically incompatible with strains selected for seasonal vaccines, using protocol-defined ILI definition.
Secondary immunogenicity purposes:
1. To evaluate the immunogenicity of aQIV compared to QIV, the measurement method was before vaccination and 21 days after vaccination. HI assay was performed on homogeneous vaccine strains in subgroups of subjects within each influenza season.
Secondary security purposes:
1. To evaluate the safety of aQIV compared with QIV, the judgment method is all adverse events (AE), serious adverse events (SAE) reported within 30 minutes after vaccination of the trial vaccine, AEs leading to early withdrawal from the trial, and special events throughout the trial period. Pay attention to the incidence of adverse events (AESI).
Exploratory purpose:
More relevant details about exploratory purposes are provided in Section 2.3, Exploratory Purposes.
Test Drug
Fluad Tetra
Active Ingredient
Fluad Tetra
Dosage Form
suspension for injection in pre-filled syringe
Dosage
0.5ml
Endpoints
The primary efficacy endpoints are defined as the time from last study vaccination to the onset of:
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus
(regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until
the end of influenza season, using the protocol-defined ILI definition.
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus
(regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until
the end of influenza season, using the protocol-defined ILI definition.
Inclution Criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Adults of ?65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-upIn order to participate in this study, all subjects must not meet any of the exclusion criteria
described below:
1. Bedridden subjects (i.e. confined to bed by sickness or old age).
2. Subjects that are incapacitated and because of that in need of a Legally Authorized
Representative.
3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive
influenza vaccine while participating in the study.
4. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this
study.
5. Known history of Guillain-Barre syndrome or another demyelinating disease such as
encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines
or blood draw.
7. Abnormal function of the immune system resulting from:
a. Clinical conditions;
b. Systemic administration of corticosteroids (PO/IV/IM)
8
at a dose ?20 mg/day of
prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to
informed consent; Topical, inhaled and intranasal corticosteroids are permitted.
Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also
permitted;
c. Administration of antineoplastic and immunomodulating agents or radiotherapy
within 90 days prior to informed consent;
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent;
9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study
vaccine within 30 days preceding the study vaccination, or planned use during the entire study
period.
10. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of Vaccination).
11. Any other clinical condition that, in the opinion of the investigator, might interfere with the
results of the study or pose additional risk to the subject due to participation in the study.
12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of
study personnel.
13. Participation in the current study for more than one season.
1. Adults of ?65 years of age on the day of vaccination.
2. Individuals who have voluntarily given written informed consent after the nature of the study
has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who have the ability to comply with study procedures including follow-upIn order to participate in this study, all subjects must not meet any of the exclusion criteria
described below:
1. Bedridden subjects (i.e. confined to bed by sickness or old age).
2. Subjects that are incapacitated and because of that in need of a Legally Authorized
Representative.
3. Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive
influenza vaccine while participating in the study.
4. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this
study.
5. Known history of Guillain-Barre syndrome or another demyelinating disease such as
encephalomyelitis and transverse myelitis.
6. Clinical conditions representing a contra-indication to intramuscular administration of vaccines
or blood draw.
7. Abnormal function of the immune system resulting from:
a. Clinical conditions;
b. Systemic administration of corticosteroids (PO/IV/IM)
8
at a dose ?20 mg/day of
prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to
informed consent; Topical, inhaled and intranasal corticosteroids are permitted.
Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also
permitted;
c. Administration of antineoplastic and immunomodulating agents or radiotherapy
within 90 days prior to informed consent;
8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent;
9. Receipt of any investigational or non-registered product (drug or vaccine) other than the study
vaccine within 30 days preceding the study vaccination, or planned use during the entire study
period.
10. Acute (severe) febrile illness (see Section 4.3 Criteria for Delay of Vaccination).
11. Any other clinical condition that, in the opinion of the investigator, might interfere with the
results of the study or pose additional risk to the subject due to participation in the study.
12. Study personnel or immediate family members (brother, sister, child, parent) or the spouse of
study personnel.
13. Participation in the current study for more than one season.
Exclusion Criteria
Exclusion Criteria:
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
Bedridden subjects (i.e. confined to bed by sickness or old age).
Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Clinical conditions;
Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
Acute (severe) febrile illness.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Participation in the current study for more than one season.
In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
Bedridden subjects (i.e. confined to bed by sickness or old age).
Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
Abnormal function of the immune system resulting from:
Clinical conditions;
Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
Acute (severe) febrile illness.
Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
Participation in the current study for more than one season.
The Estimated Number of Participants
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Taiwan
1000 participants
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Global
35800 participants
