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

NCT ID: NCT06029933

Last Updated: 2023-09-08

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

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Recruitment Status

RECRUITING

Total Enrollment

960000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-17

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza Community-acquired Pneumonia Cardiovascular Events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fluad Recipients

Kaiser Permanente Northern California members aged ≥65 years who receive Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

Adjuvanted Quadrivalent Inactivated Influenza Vaccine (aIIV4)

Intervention Type BIOLOGICAL

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.

Fluzone High-Dose Recipients

Kaiser Permanente Northern California members aged ≥65 years who receive High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

High-Dose Quadrivalent Inactivated Influenza Vaccine (HD-IIV4)

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Fluad Fluzone High-Dose

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaiser Permanente Northern California (entire region)

Oakland, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amber H. Hyman, PhD, MPH

Role: CONTACT

510-267-7571

Facility Contacts

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Amber H. Hyman, PhD, MPH

Role: primary

510-267-7517

Other Identifiers

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2033496

Identifier Type: -

Identifier Source: org_study_id

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