Trade name: BEXSERO, TRUMENBA®
Generic names: Meningococcal Group B Vaccine suspension for intramuscular injection,
Indication and Usage:
BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years. Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age
Ingredients:
Each 0.5-mL dose of BEXSERO is formulated to contain 50 micrograms each of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), 25 micrograms of Outer Membrane Vesicles (OMV), 1.5 mg aluminum hydroxide (0.519 mg of Al3+), 3.125 mg sodium chloride, 0.776 mg histidine, and 10 mg sucrose at pH 6.4 to 6.7. Each dose contains less than 0.01 micrograms kanamycin (by calculation).
Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHbp)
variants from N. meningitidis serogroup B, one from fHbp subfamily A and one from subfamily B (A05 and
B01, respectively). The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.
Each 0.5 mL dose contains 60 micrograms of each fHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0.
Manufacturer-listed adverse reactions |
Bexsero® can cause: Injection site reactions (including extensive swelling of the vaccinated limb, blisters at or around the injection site, and the injection site nodule which may persist for more than 1 month), Allergic/anaphylactic reactions, Rash, Eye Swelling, Syncope (fainting), Vasovagal responses.
Trumenba® can cause: Hypersensitivity reactions, Anaphylactic reactions, Syncope (fainting).
Limitations of Effectiveness:
BEXSERO may not protect all vaccine recipients. BEXSERO may not provide protection against all meningococcal serogroup B strains
Vaccination with Trumenba may not protect all vaccine recipients against N. meningitidis serogroup B infections.
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