NCT06676644

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Influenza Vaccines
• Elderly

Interventions

Type	Name	Description
DRUG	adjuvanted	adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
DRUG	non-adjuvanted	non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

Timeline

• Start date: 2024-11-21
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-11-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: Taiwan