Healthy Adult Participants study: RabAvert
Official title Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
ClinicalTrials.gov ID: NCT07914673
What this study is testing
What is Trivalent inactivated influenza vaccine?
Trivalent inactivated influenza vaccine is an investigational medicine, being studied as a potential treatment for healthy adult participants.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being done to better understand how the immune system responds to vaccination against influenza and rabies.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Healthy participants 18 to 40 years of age or ≥65 years of age.
- Able to understand and give informed consent.
- Willing to receive RabAvert vaccine.
- Willing to receive TIV (trivalent influenza vaccine).
- In stable health, as determined by medical history and targeted physical exam related to this history.
You likely can't join if
- Has a history of severe local or systemic reactions to any vaccination.
- Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
- Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure...
- Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring...
- Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥...
See the full eligibility criteria
- Healthy participants 18 to 40 years of age or ≥65 years of age.
- Able to understand and give informed consent.
- Willing to receive RabAvert vaccine.
- Willing to receive TIV (trivalent influenza vaccine).
- In stable health, as determined by medical history and targeted physical exam related to this history.
- Willing to give blood and optional lymph node FNA (fine needle aspiration) samples.
- Has a history of severe local or systemic reactions to any vaccination.
- Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
- Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure to rabies virus.
- Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for...
- Is acutely ill or febrile (temperature \>38.0 C [100.4F] less than 72 hours prior to or at the Day 1 visit. Participants who meet this criterion may be rescheduled.
- Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
- History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
- Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
- Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days...
- Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
- Unwilling to use an effective method of contraception if you are of childbearing potential.
The study team makes the final eligibility decision.
Where it is enrolling
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at St Louis, Missouri, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.