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Cancer Vaccine
Flu Vaccines for Influenza
Phase 4
Recruiting
Led By Emmanuel B Walter, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 18-64 years that have not received the current season's influenza vaccine
Be between 18 and 65 years old
Must not have
History of Guillain-Barré syndrome
Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
"This trial is testing two different flu vaccines to see which one gives a better immune response. Participants will be randomly assigned to receive either the Flucelvax vaccine or the Flublok or Fl
Who is the study for?
This trial is for individuals who want to help test the effectiveness of different flu vaccines: Flucelvax, Flublok, or Fluzone. Participants should be willing to provide blood and saliva samples over several months and report any symptoms of influenza-like illness.
What is being tested?
The study compares three approved flu vaccines by measuring immune responses in participants. It involves random assignment to one vaccine type, regular health surveys, and collection of blood/saliva at specific times to assess immunogenicity.
What are the potential side effects?
Common side effects from flu vaccinations can include soreness at the injection site, mild fever, muscle aches, and fatigue. Rarely more serious reactions like allergic responses could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old and haven't had this season's flu shot.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had Guillain-Barré syndrome in the past.
Select...
I am not pregnant and do not plan to become pregnant in the next 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric mean fold rise (GMFR) in HAI titer from baseline
Number of participants demonstrating seroconversion from baseline
Participants with a seroprotective HAI titer (≥1:40)
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Flucelvax (ccIIV4)Experimental Treatment1 Intervention
Participants will receive Flucelvax (ccIIV4) at Visit 1.
Group II: Flublok (RIV) or Fluzone (IIV)Experimental Treatment1 Intervention
Participants will receive Flublok (RIV) or Fluzone (IIV) at Visit 1.
Find a Location
Who is running the clinical trial?
VA Medical Center-ClevelandUNKNOWN
University of PittsburghOTHER
1,790 Previous Clinical Trials
16,359,203 Total Patients Enrolled
Washington University School of MedicineOTHER
1,999 Previous Clinical Trials
2,334,888 Total Patients Enrolled
Duke UniversityLead Sponsor
2,461 Previous Clinical Trials
2,968,907 Total Patients Enrolled
Arizona State UniversityOTHER
302 Previous Clinical Trials
107,458 Total Patients Enrolled
VA Northeast Ohio Health CareUNKNOWN
1 Previous Clinical Trials
455 Total Patients Enrolled
Centers for Disease Control and PreventionFED
892 Previous Clinical Trials
22,000,294 Total Patients Enrolled
University Hospitals Cleveland Medical CenterOTHER
329 Previous Clinical Trials
390,865 Total Patients Enrolled
Emmanuel B Walter, MD, MPHPrincipal InvestigatorDuke University
5 Previous Clinical Trials
1,243 Total Patients Enrolled