NCT03183908

FLUAD® vs. Fluzone® High-Dose Study

Safety and Immunogenicity of Adjuvanted Versus High-Dose Inactivated Influenza Vaccines in Older Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 757 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Full Analysis Population 1: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary. Full Analysis Population 2: Defined as all subjects who are randomized and vaccinated. Immunogenicity Population: Defined as subjects who received vaccine, provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	FLUAD®	Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICAL	Fluzone® High-Dose	Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Timeline

• Start date: 2017-08-28
• Primary completion: 2019-02-14
• Completion: 2019-02-14
• First posted: 2017-06-12
• Last updated: 2021-03-30
• Results posted: 2021-03-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study