FLUAD® vs. Fluzone® High-Dose Study

Summary

The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.

Conditions

• Pain
• Quality of Life
• Injection Site Reaction
• Side Effect of Drug
• Adverse Drug Event

Interventions

BIOLOGICAL

FLUAD®

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

BIOLOGICAL

Fluzone® High-Dose

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• Boston Medical Center

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Duke University

  lead OTHER

Principal Investigators

• Kenneth Schmader, MD · Duke University

• Theresa Harrington, MD · Centers for Disease Control and Prevention

• Elizabeth Barnett, MD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-28

Primary Completion

2019-02-14

Completion

2019-02-14

FDA Drug

Yes

Countries

• United States

Study Locations