Phase 3 Single Arm, Open Study on vYF in Adults (NCT07222059) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Single Arm, Open Study on vYF in Adults
Japan254 participantsStarted 2025-10-23
Plain-language summary
The purpose of this study is to assess the safety and immunogenicity of vYF in adults aged 18 years and over in Japan.
Study details include:
* The study duration will be up to approximately 1 month.
* One single dose of vYF will be administrated subcutaneously at the 1st visit.
* The visit frequency will be Day 01 (Visit 01) and Day 29 (Visit 02). One telephone call (TC) will be planned at Day 15.
Number of Participants:
A total of 254 participants is expected to be included in the study with the aim to obtain a total of 203 evaluable participants.
Study Arms and Duration:
Eligible participants will receive, subcutaneously, a single dose of vYF vaccine on Day 1.
The duration of each participation will be approximately 1 month for each participant.
Who can participate
Age range
18 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:
* Aged from 18 years on the day of inclusion\*
\* "From 18 years" means from the day of the 18th birthday
* Participants who are healthy as determined by medical evaluation including medical history and physical examination.
* Able to attend all scheduled visits and to comply with all study procedures
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
OR
. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 01 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.
\- Informed consent form (ICF) has been signed and dated Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, …
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
Percentage of participants with seroconversion to YF virus in YF-naive participants