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Clinical Trials List

Protocol NumberV118_24
Active

2023-09-01 - 2026-06-30

Phase III

Recruiting5

ICD-10J09.X1

Influenza due to identified novel influenza A virus with pneumonia

ICD-10J10.00

Influenza due to other identified influenza virus with unspecified type of pneumonia

ICD-10J10.08

Influenza due to other identified influenza virus with other specified pneumonia

ICD-10J11.00

Influenza due to unidentified influenza virus with unspecified type of pneumonia

ICD-10J11.08

Influenza due to unidentified influenza virus with specified pneumonia

ICD-9487.0

Influenza with pneumonia

A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Subunit Inactivated Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Seqirus UK Limited

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yi-Ching Yang Division of Family Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator MING-CHE LIU Division of Urology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuam-Jang Lee 無
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Yuan Lin Division of Family Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Fu-Lun Chen
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NA

Objectives

1a. To demonstrate the efficacy of MF59-adjuvanted influenza vaccine in the prevention of RTPCR-confirmed influenza A and/or B disease due to any influenza strain is non-inferior to that of a non-adjuvanted influenza vaccine comparator in adults ≥65 years of age. Success Criterion for non-inferiority: The non-inferiority of the efficacy of MF59-adjuvanted influenza vaccine will be demonstrated against the non-adjuvanted influenza vaccine comparator if the lower limit (LL) of the interim analysis (IA) adjusted two-sided 95%* CI for the relative vaccine efficacy (rVE) is above or equal to -20%. 1b. To demonstrate the efficacy of MF59-adjuvanted influenza vaccine in the prevention of RTPCR-confirmed influenza A and/or B disease due to any influenza strain is superior to that of a non-adjuvanted influenza vaccine influenza vaccine comparator in adults ≥65 years of age. Success Criterion for superiority: The superiority of the efficacy of MF59-adjuvanted influenza vaccine will be demonstrated against the non- adjuvanted influenza vaccine comparator if the LL of the IA adjusted two-sided 95%* CI for the rVE is above 0%.

Test Drug

intramuscular injection

Active Ingredient

Influenza Vaccine, Adjuvanted

Dosage Form

251

Dosage

A single 0.5 mL dose for intramuscular injection

Endpoints

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, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
5. Known history of Guillain-Barré 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.

Inclution Criteria

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-up7
.

Exclusion 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-up

The Estimated Number of Participants

  • Taiwan

    1000 participants

  • Global

    35800 participants

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