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RecruitingNCT06029933

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

Relative Vaccine Effectiveness of Adjuvanted Inactivated Influenza Vaccine (aIIV) vs High-Dose Inactivated Influenza Vaccine (HD-IIV) for Prevention of Lab-Confirmed Influenza Among Adults ≥65 Years of Age in the United States

Sponsor

Kaiser Permanente

Enrollment

1,500,000 participants

Start Date

Aug 17, 2023

Study Type

OBSERVATIONAL

Conditions

InfluenzaCommunity-acquired PneumoniaCardiovascular Events

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, 2024/25, and 2026/27 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4) and a biological treatment called High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4) for people with cardiovascular events, community-acquired pneumonia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 65 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAdjuvanted 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.

BIOLOGICALHigh-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(1)

Kaiser Permanente Northern California (entire region)

Oakland, California, United States

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NCT06029933

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