MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
ConditionNeisseria Meningitidis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-25
SponsorEmory University
About this trial
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?
Eligibility criteria
Qualifiers
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
Disqualifiers
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 of responses or the subject's successful completion of this trial. Chronic medical conditions that are stable, with no escalation in medication doses or new medications administered in the preceding 3 months, will not be considered exclusionary.)
Presence of self-reported or medically documented significant medical or psychiatric condition(s) as determined by the investigator.
Trial design
Treatments tested in this trial
- Trumenba
- PENBRAYA
Treatment groups
125 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov