Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines (influenza)

February 22, 2026 updated by: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly

To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Annual influenza vaccination is the most important and cost-effective intervention in reducing the impact of influenza, and a key component of the WHO response and preparedness efforts for influenza of pandemic potential. Reduced effectiveness of conventional egg-based vaccination was observed among risk group, such as elderly and people on with chronic medical conditions, which may result from their impaired immunogenicity. WHO, as well as ACIP of the USA, Europe, and Australia suggested adjuvanted influenza vaccines as one of alternatives for those people, which could decrease the disease burden significantly in several analyses. An adjuvanted commercial vaccine has been approved in Taiwan recently, but the local data of safety and effectiveness analysis is limited. This 1-year randomized control trial is designed to estimate the safety and effectiveness of adjuvanted influenza vaccine among Asian elderly people when compared to non-adjuvanted vaccines.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jann-Tay Wang Clinical Professor, M. D., Ph.D.
  • Phone Number: 263517 +886-2-2312-3456
  • Email: wangjt1124@ntuh.gov.tw

Study Contact Backup

  • Name: Un-In Wu Clinical Associate Professor, M. D.
  • Phone Number: 265054 +886-2-2312-3456
  • Email: uninwu@gmail.com

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
          • National Taiwan University Hospital Research Ethics Committee
          • Phone Number: 288576 +886-2312-3456
          • Email: fctsai@ntu.edu.tw
        • Principal Investigator:
          • Jann-Tay Wang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 65 years or above
  • Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.

Exclusion Criteria:

  • Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency
  • Prior receipt of influenza vaccination during the current flu season.
  • Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: adjuvanted
adjuvanted (aIIV4) influenza vaccine
Drug: adjuvanted
adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
Active Comparator: non-adjuvanted
non-adjuvanted (IIV4) influenza vaccine
Drug: non-adjuvanted
non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29.
Time Frame: Measured through Day 29
The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29.
Measured through Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7)
Time Frame: Measured through Day 361
The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7)
Measured through Day 361
Incidence of severe adverse reactions within 28 days after immunization.
Time Frame: Measured through Day 28
Incidence of severe adverse reactions within 28 days after immunization.
Measured through Day 28
Incidence of laboratory-confirmed influenza during the study period.
Time Frame: Measured through Day 361
Incidence of laboratory-confirmed influenza during the study period.
Measured through Day 361
Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period.
Time Frame: Measured through Day 361
Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period.
Measured through Day 361

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202409030MIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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