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

NCT06029933 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 960000

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Seqirus

    collaborator INDUSTRY

  • Kaiser Permanente

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2025-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029933 on ClinicalTrials.gov