title: A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults.
abstract: BACKGROUND
  Neisseria meningitidis serogroup B (MnB) is an important cause of invasive meningococcal disease (IMD). A MnB vaccine (bivalent rLP2086, Trumenba(®)) consisting of 2 factor H binding protein variants received accelerated approval in the United States for the prevention of IMD caused by MnB in individuals 10-25 years of age. This randomized, active-controlled, observer-blind study further assessed the safety and tolerability of bivalent rLP2086.
  
  
  METHODS
  Eligible subjects ≥ 10 to < 26 years were randomized (2:1) to receive bivalent rLP2086 at months 0, 2, and 6, or hepatitis A virus vaccine (HAV, Havrix(®)) at months 0 and 6, and saline at month 2. The primary endpoints were serious adverse events (SAEs) throughout the study and medically-attended adverse events (MAEs) within 30 days after vaccination. Additional safety assessments included SAEs at other study intervals and adverse events (AEs) during the vaccination phase.
  
  
  RESULTS
  Of 5712 subjects randomized, 84.6% (n = 3219) of bivalent rLP2086 recipients and 87.2% (n = 1663) of HAV/saline recipients completed the study. Throughout the study, SAEs were reported for 1.6% and 2.5% of bivalent rLP2086 and HAV/saline recipients, respectively. SAEs related to either vaccine were rare. MAEs occurred in 7.0% and 6.1% of subjects after vaccination 1; 5.5% and 6.1% after vaccination 2; and 5.3% and 5.5% after vaccination 3 in the bivalent rLP2086 and HAV/saline groups, respectively. A greater proportion of subjects reported AEs during the vaccination phase after bivalent rLP2086 compared with HAV/saline recipients; however, when reactogenicity events were excluded, the proportion between groups was similar.
  
  
  CONCLUSIONS
  This safety study, the largest randomized, active-controlled trial evaluating a recombinant MnB vaccine, demonstrated that bivalent rLP2086 is safe and tolerable in healthy individuals ≥ 10 to < 26 years of age.
authors: Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. Electronic address: larsoest@rm.dk.
authors: Lars
authors: L
authors: Ostergaard
authors: Tekton Research, 4534 West Gate Blvd, Austin, TX 78745, USA. Electronic address: glucksinger@tektonresearch.com.
authors: Gregg H
authors: GH
authors: Lucksinger
authors: Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: Judith.Absalon@pfizer.com.
authors: Judith
authors: J
authors: Absalon
authors: Pfizer Ltd, Walton Oaks, Tadworth, UK. Electronic address: johannes.beeslaar@pfizer.com.
authors: Johannes
authors: J
authors: Beeslaar
authors: Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: joseph.eiden@pfizer.com.
authors: Joseph
authors: J
authors: Eiden
authors: Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: kathrin.jansen@pfizer.com.
authors: Kathrin U
authors: KU
authors: Jansen
authors: Pfizer Medical & Scientific Affairs, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: laura.york@pfizer.com.
authors: Laura J
authors: LJ
authors: York
authors: Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: angela.quinn@pfizer.com.
authors: Angela
authors: A
authors: Quinn
authors: Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. Electronic address: metgrave@rm.dk.
authors: Mette E
authors: ME
authors: Graversen
authors: Pfizer Vaccine Research, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: john.perez@pfizer.com.
authors: John L
authors: JL
authors: Perez
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D022362:Hepatitis A Vaccines / Q000008:administration & dosage; D006801:Humans; D038622:Internationality; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D038541:Neisseria meningitidis, Serogroup B; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D022362:Hepatitis A Vaccines; D022401:Meningococcal Vaccines; D014614:Vaccines, Synthetic
keywords: Adolescents; Bivalent rLP2086; Meningitis; Safety; Vaccine