Phase 4
N=459
FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care
Flu
Bottom Line
View on ClinicalTrials.gov: NCT03694808 ↗Enrolled (actual)
459
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Overall Hemagglutinin Inhibition (HAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. — 213.4; 261.9; 70.5; 67.2 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluad Vaccine (Drug); Fluzone HD Vaccine (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- David H. Canaday
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Hemagglutinin Inhibition (HAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
213.4; 261.9; 70.5; 67.2 | — |
| PRIMARY Overall Hemagglutinin Inhibition (HAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
375.5; 517.3; 140.2; 120.4 | — |
| PRIMARY Overall Hemagglutinin Inhibition (HAI) B Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
113.6; 210.4; 75.5; 66.1 | — |
| PRIMARY Overall HAI H1N1 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
29.2; 44.6; 48.5; 43 | — |
| PRIMARY Overall HAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
35.2; 57; 70.9; 70.1 | — |
| PRIMARY Overall HAI B Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
34.1; 47.7; 36.9; 39.3 | — |
| SECONDARY Overall Neuraminidase Inhibition (NAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
167.7; 71.8; 666.4; 297.8 | — |
| SECONDARY Overall Neuraminidase Inhibition (NAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
27.3; 24.9; 46.7; 44.7 | — |
| SECONDARY Overall H1N1 NAI Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
64; 9.6; 60.2; 43.4 | — |
| SECONDARY Overall NAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
20.9; 10.5; 32; 20.8 | — |
| SECONDARY Overall Serum Virus Neutralization (SVN) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
675.7; 791.3 | — |
| SECONDARY Heterologous Immunity at 1 Month Post-vaccination Will be Compared Between FLUAD and FLUZONE HD. |
— | — |
| SECONDARY Overall Serum Virus Neutralization (SVN) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
270.8; 405.0 | — |
| SECONDARY Overall Serum Virus Neutralization (SVN) H1N1 Seroconversion Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
32.3; 31.3 | — |
| SECONDARY Overall Serum Virus Neutralization (SVN) H3N2 Seroconversion Between FLUAD and FLUZONE HD at 1 Month Post-vaccination. |
21.2; 43.1 | — |
Summary
Adjuvanted flu vaccine, Fluad, is not immunologically inferior to HD influenza vaccine in older persons living in long-term care.
Eligibility Criteria
Inclusion Criteria
- > 65 years old
- Able to obtain consent from subject or legally authorized representative (subject to provide assent if cognitively/physically able to do so)
- Able to participate throughout the study period
Exclusion Criteria
- Recent illness (within 30 days) severe enough to require hospitalization or physician-directed outpatient pharmacotherapy
- Administration of immunomodulatory agents (e.g. oral corticosteroids except prednisone < 10 mg daily, cyclosporine, and biologics (DMARDS) for Rheumatologic/Dermatologic conditions) in the last 3 months
- Cancer requiring treatment in the past three years, except for non- melanoma skin cancers or cancers that have clearly been cured or carry an excellent prognosis including prostate cancer.
- Myocardial infarction, major heart surgery (i.e. valve replacement or bypass surgery), stroke, deep vein thrombosis or pulmonary embolus in the past 4 months
- Allergies or history of significant adverse reactions to any component of influenza vaccine including egg protein and latex or after a previous dose of any influenza vaccine.
- History of Guillian-Barré Syndrome within 6 weeks of a prior influenza vaccine.
Data sourced from ClinicalTrials.gov (NCT03694808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.