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Inactivated Influenza Vaccine

FLUAD® vs. Fluzone® High-Dose Study

Phase 4
Waitlist Available
Led By Theresa Harrington, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29 (28 days post-vaccination)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved

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.

Eligible Conditions
  • Injection Site Reaction
  • Pain
  • Quality of Life
  • Side Effects
  • Adverse Drug Reactions

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29 (28 days post-vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 (28 days post-vaccination) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Adverse Events of Clinical Interest, Population 2
Number of Participants With H3N2 HAI Seroconversion
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
+1 more
Secondary study objectives
Geometric Mean HAI Titer - 65 and Older
Geometric Mean HAI Titer - Ages 65-79
Geometric Mean HAI Titer - Ages 80 and Older
+21 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Adjuvanted influenza vaccine (FLUAD®)Active Control1 Intervention
In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.
Group II: High-dose influenza vaccine (Fluzone® HD)Active Control1 Intervention
In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,005 Total Patients Enrolled
3 Trials studying Injection Site Reaction
914 Patients Enrolled for Injection Site Reaction
Children's Hospital Medical Center, CincinnatiOTHER
839 Previous Clinical Trials
6,564,846 Total Patients Enrolled
2 Trials studying Injection Site Reaction
647 Patients Enrolled for Injection Site Reaction
Boston Medical CenterOTHER
405 Previous Clinical Trials
884,204 Total Patients Enrolled
Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,980,790 Total Patients Enrolled
3 Trials studying Injection Site Reaction
914 Patients Enrolled for Injection Site Reaction
Theresa Harrington, MDPrincipal InvestigatorCenters for Disease Control and Prevention
3 Previous Clinical Trials
2,175 Total Patients Enrolled
Elizabeth Barnett, MDPrincipal InvestigatorBoston University
1 Previous Clinical Trials
350 Total Patients Enrolled
Kenneth Schmader, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
267 Total Patients Enrolled
1 Trials studying Injection Site Reaction
267 Patients Enrolled for Injection Site Reaction
~92 spots leftby Dec 2025