Fluad vs. Fluzone High-Dose Vaccine Effectiveness Among Adults ≥65 Years

Influenza Clinical Trial

Official title:

Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine vs High-Dose Quadrivalent Inactivated Influenza Vaccine Among Adults ≥65 Years for the 2023-24 and 2024-25 Seasons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029933
• Other study ID #: 2033496
• Status: Recruiting
• Start date: August 17, 2023
• Est. completion date: May 2026

Study information

• Verified date: September 2023
• Source: Kaiser Permanente
• Contact: Amber H. Hyman, PhD, MPH
• Phone: 510-267-7571
• Email: Amber.Hyman[@]kp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 960000
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age =65 years at the time of influenza vaccination

• KPNC member at the time of vaccination

• Receive either aIIV4 or HD-IIV4 at a KPNC facility during the 2023/24 and/or 2024/25 influenza seasons

Exclusion Criteria:

• Age <65 years at the time of influenza vaccination

• Received either aIIV4 or HD-IIV4 in the inpatient setting

• Receive more than one influenza vaccination during a single season period (i.e., 2023/24 or 2024/25 influenza seasons)

• Receive an influenza vaccination outside of KPNC

Related Conditions & MeSH terms

• Cardiovascular Events
• Community-acquired Pneumonia
• Influenza
• Influenza, Human

Intervention

Biological:
• Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)
Fluad Quadrivalent vaccine is an inactivated influenza vaccine formulated to contain 60 mcg of hemagglutinin (HA) total, with 15 mcg from each of the four recommended influenza strains and the MF59 adjuvant in single-dose prefilled 0.5 mL syringes. Kaiser Permanente Northern California members =65 years may receive Fluad as part of routine clinical care during the influenza season.
• High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)
Fluzone High-Dose Quadrivalent vaccine is an inactivated split virion influenza vaccine formulated to contain 240 mcg of HA total, with 60 mcg from each of the four recommended influenza strains in single-dose prefilled 0.7 mL syringes. Kaiser Permanente Northern California members =65 years may receive Fluzone High-Dose as part of routine clinical care during the influenza season.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California (entire region)	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization for cardiovascular events	KPNC members =65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for cardiovascular events. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)
Other	PCR-confirmed influenza in subgroups with comorbidities	KPNC members =65 years with comorbidities (e.g., cardiovascular and respiratory conditions, diabetes, obesity) who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)
Primary	PCR-confirmed influenza	KPNC members =65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for the presence of PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)
Secondary	Emergency department visit or hospitalization for PCR-confirmed influenza	KPNC members =65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for an emergency department visit or hospitalization for PCR-confirmed influenza. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)
Secondary	Hospitalization for PCR-confirmed influenza	KPNC members =65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for PCR-confirmed influenza. This outcome will be assessed in a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)
Secondary	Hospitalization for all-cause community-acquired pneumonia	KPNC members =65 years who receive Fluad or Fluzone High-Dose will be retrospectively assessed for hospitalization for all-cause community-acquired pneumonia. This outcome will be assessed in single-season analyses (2023/24 and 2024/25 separately) and a pooled 2-seasons analysis (2023/24 and 2024/25 combined).	=14 days after vaccination until date of outcome, death, loss-to-follow-up, or end of each season (estimated May 2024 or May 2025)