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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine

NCT03718468

Influenza

COMPLETED PHASE3

Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Adults and Elders

NCT01003145

Influenza

COMPLETED NA

Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)

NCT00310648

Influenza

COMPLETED PHASE3

Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Taiwanese Adults 65 Years of Age and Older

NCT04537234

Influenza (Healthy Volunteers)

COMPLETED PHASE3

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

NCT01766921

Pandemic H5N1 Influenza

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Vaccines Elderly

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

adjuvanted

adjuvanted (aIIV4) influenza vaccine

Group Type EXPERIMENTAL

adjuvanted

Intervention Type DRUG

adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

non-adjuvanted

non-adjuvanted (IIV4) influenza vaccine

Group Type ACTIVE_COMPARATOR

non-adjuvanted

Intervention Type DRUG

non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adjuvanted

adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

Intervention Type DRUG

non-adjuvanted

non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No