MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults (NCT07197762) | Clinical Trial Compass
RecruitingPhase 4
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
United States125 participantsStarted 2025-11-04
Plain-language summary
The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
The main questions it aims to answer are:
* How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine?
* How strong is the immune response after vaccination, and how many people show a noticeable boost in immune response?
Who can participate
Age range18 Years – 25 Years
SexALL
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Inclusion Criteria:
* Provides written informed consent before any study procedures are performed.
* Be able to understand and agree to comply with planned study procedures and be available for all study visits.
* Subject is in good health as determined by vital signs, medical history, targeted physical examination (if indicated), and the judgment of the investigator.
* Vaccinated with 2-dose Bexsero primary series at least 2.5 years before vaccination. Must confirm vaccination status and dates of administration through GRITS, healthcare provider, or other official documentation
* Women of childbearing potential must agree to use or have practiced true abstinence2 or use at least one acceptable primary form of contraception from 28 days prior through 28 days after vaccination.
* Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours before vaccination
Exclusion Criteria:
* Subject has an acute illness with fever (temperature ≥100.4 °F) within 72 hours before vaccine administration.
* Subject is currently pregnant or breastfeeding an infant/child.
* Has any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation. (Including acute, subacute, intermittent,t or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation…