Actively Recruiting
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
Led by Emory University · Updated on 2025-12-22
125
Participants Needed
2
Research Sites
56 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provides written informed consent before any study procedures.
- Able to understand and agree to comply with study procedures and attend all visits.
- In good health based on vital signs, medical history, and physical exam.
- Received 2-dose Bexsero vaccine series at least 2.5 years before vaccination, confirmed by official records.
- Women of childbearing potential agree to use effective contraception or abstain from 28 days before through 28 days after vaccination.
- Women of childbearing potential have a negative pregnancy test within 24 hours before vaccination.
You will not qualify if you...
- Has a fever (temperature 60.4 6F) within 72 hours before vaccination.
- Currently pregnant or breastfeeding.
- Has any medical condition that could increase risk or interfere with study participation, unless stable with no recent medication changes.
- Has significant medical or psychiatric conditions as judged by the investigator.
- Received or plans to receive a live vaccine within 4 weeks before or after study vaccination.
- Received or plans to receive an inactivated vaccine within 2 weeks before or 4 weeks after study vaccination.
- History of severe allergic reaction to any vaccine or its components.
- Has bleeding disorders that prevent intramuscular injections.
- Received any MenB vaccine within the last 2.5 years.
- Received more than 2 doses of MenB vaccines.
- Has known or suspected immune system defects preventing vaccine response, including certain immune deficiencies, high-dose corticosteroids, or immunosuppressive therapy.
- Has significant neurological disorders or history of seizures (except simple febrile seizures).
- Has neuroinflammatory or autoimmune conditions requiring immunomodulatory treatment, including Guillain-Barr�e9 syndrome, transverse myelitis, uveitis, optic neuritis, or multiple sclerosis.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Emory Children's Center-Vaccine Research Clinic
Atlanta, Georgia, United States, 30329
Actively Recruiting
2
Hope Clinic
Atlanta, Georgia, United States, 30329
Actively Recruiting
Research Team
C
Christina Rostad, MD
CONTACT
J
Jessica McCaffery, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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