Trumenba Meningitis B Description
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.
Trumenba Meningitis B Indication
Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B (Men B)
Trumenba Meningitis B Dosage
Trumenba is intended for intramuscular injection administered as a two or three-dose series in individuals 10 through 25 years of age following a 0-, 2-, and 6-month schedule. The two dose series is recommended for healthy adolescents (16) and young adults.
On October 29, 2014, the U.S. Food and Drug Administration sent an approval letter authorizing the introduction or delivery of Trumenba into interstate commerce.
Trumenba Meningitis B Clinical Trials
Pfizer's Trumenba has been involved in over 10 clinical trials to test the safety, tolerability and immunogenicity.