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

Not Applicable

Not yet recruiting

• Conditions: Elderly; Influenza Vaccines
• Interventions: Drug: adjuvanted; Drug: non-adjuvanted

• Registration Number: NCT06676644
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Study First Posted: 2024-11-06
• Last Update Posted: 2024-11-06
• Study Start: 2025-11-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adjuvanted	adjuvanted	adjuvanted (aIIV4) influenza vaccine
non-adjuvanted	non-adjuvanted	non-adjuvanted (IIV4) influenza vaccine

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

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