Status:
RECRUITING
MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults
Lead Sponsor:
Emory University
Collaborating Sponsors:
Pfizer
Conditions:
Neisseria Meningitidis
Eligibility:
All Genders
18-25 years
Phase:
PHASE4
Brief 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. ...
Detailed Description
Neisseria meningitidis is a human-restricted pathogen that colonizes the nasopharynx and, in rare cases, invades the bloodstream or central nervous system, leading to invasive meningococcal disease (I...
Eligibility Criteria
Inclusion
- 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
- 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.
- Received or plans to receive a licensed, live vaccine within 4 weeks before or after the study vaccination.
- Received or plans to receive a licensed, inactivated vaccine within 2 weeks before through 4 weeks after the study vaccination.
- Any previous severe hypersensitivity or anaphylactic reaction to any vaccine or vaccine-related component
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Received any MenB vaccine within the last 2.5 years before vaccination.
- Received more than 2 doses of Bexsero or any other MenB vaccine(s) (e.g. Trumenba or Penbraya)
- Any known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy \>20 mg per day for ≥14 days, or those receiving immunosuppressive therapy. Participants with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory condition or autoimmune condition requiring immunomodulatory treatment, including, but not limited to, Guillain-Barré syndrome, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Key Trial Info
Start Date :
November 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07197762
Start Date
November 4 2025
End Date
December 1 2026
Last Update
December 22 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Emory Children's Center-Vaccine Research Clinic
Atlanta, Georgia, United States, 30329
2
Hope Clinic
Atlanta, Georgia, United States, 30329