• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Bexsero (Meningococcal Group B Vaccine)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Bexsero (Meningococcal Group B Vaccine)

  • Profile

Profile

Contact Information

Contact: GlaxoSmithKline
Website: www.bexsero.com

Currently Enrolling Trials

    Show More

    General Information

    Bexsero is a multicomponent Meningococcal Serogroup B vaccine.

    Bexsero is specifically indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Bexsero is approved for use in individuals 10 through 25 years of age.

    Bexsero is supplied as a solution for intramuscular administration. Bexsero should be administer in two doses (0.5 mL each) at least 1 month apart.

    Mechanism of Action

    Bexsero is a multicomponent Meningococcal Serogroup B vaccine. NHBA, NadA, fHbp, and PorA are proteins found on the surface of meningococci and contribute to the ability of the bacterium to cause disease. Vaccination with Bexsero leads to the production of antibodies directed against NHBA, NadA, fHbp, and PorA P1.4. The susceptibility of serogroup B meningococci to complement-mediated antibodydependent killing following vaccination with Bexsero is dependent on both the antigenic similarity of the bacterial and vaccine antigens, as well as the amount of antigen expressed on the surface of the invading meningococci.

    Side Effects

    Adverse effects associated with the use of Bexsero may include, but are not limited to, the following:

    • pain at the injection site
    • myalgia
    • erythema
    • fatigue
    • headache
    • induration
    • nausea
    • arthralgia

    Clinical Trial Results

    The FDA approval of Bexsero was based on three studies conducted in Canada, Australia, Chile, and the United Kingdom in approximately 2,600 adolescents and young adults. Among subjects who received two doses of Bexsero, after vaccination, 62 to 88% had antibodies in their blood that killed three different N. meningitidis serogroup B strains in tests carried out in a laboratory, compared with 0 to 23% before vaccination. These three strains are representative of strains that cause serogroup B meningococcal disease in the U.S.

    Approval Date: 2015-01-01
    Company Name: GlaxoSmithKline
    Back to Listings

    Upcoming Events

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing