WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymp… (NCT07386509) | Clinical Trial Compass
TerminatedEarly Phase 1
WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymphoid Tissues.
Stopped: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant.
No minor deviations to report
United States2 participantsStarted 2020-03-17
Plain-language summary
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Healthy subjects aged 18-49 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods\* for 28 days before and 28 days after rabies vaccination.
* Women of child-bearing potential using licensed hormonal methods must also use a second form of contraception.
4\. Are in good health, as determined by medical history and targeted physical exam related to this history.
5\. Willing to give FNA specimens for the study.
6\. The following laboratory values obtained within 14 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
• Absolute neutrophil count (ANC) ≥750 cells/mm3
• Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
* Platelet count ≥100,000/mm3
* Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
* NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of antibody titers at Day 28 versus baseline