PMID- 26845739 OWN - NLM STAT- MEDLINE DCOM- 20161006 LR - 20161230 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 34 IP - 12 DP - 2016 Mar 14 TI - 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. PG - 1465-71 LID - S0264-410X(16)00096-7 [pii] LID - 10.1016/j.vaccine.2016.01.044 [doi] AB - BACKGROUND: Neisseria meningitidis serogroup B (MnB) is an important cause of invasive meningococcal disease (IMD). A MnB vaccine (bivalent rLP2086, Trumenba((R))) 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((R))) 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. CONCLUSION: 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. CI - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Ostergaard, Lars AU - Ostergaard L AD - Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. Electronic address: larsoest@rm.dk. FAU - Lucksinger, Gregg H AU - Lucksinger GH AD - Tekton Research, 4534 West Gate Blvd, Austin, TX 78745, USA. Electronic address: glucksinger@tektonresearch.com. FAU - Absalon, Judith AU - Absalon J AD - Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: Judith.Absalon@pfizer.com. FAU - Beeslaar, Johannes AU - Beeslaar J AD - Pfizer Ltd, Walton Oaks, Tadworth, UK. Electronic address: johannes.beeslaar@pfizer.com. FAU - Eiden, Joseph AU - Eiden J AD - Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: joseph.eiden@pfizer.com. FAU - Jansen, Kathrin U AU - Jansen KU AD - Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: kathrin.jansen@pfizer.com. FAU - York, Laura J AU - York LJ AD - Pfizer Medical & Scientific Affairs, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: laura.york@pfizer.com. FAU - Quinn, Angela AU - Quinn A AD - Pfizer Vaccine Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Electronic address: angela.quinn@pfizer.com. FAU - Graversen, Mette E AU - Graversen ME AD - Department of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark. Electronic address: metgrave@rm.dk. FAU - Perez, John L AU - Perez JL AD - Pfizer Vaccine Research, 500 Arcola Road, Collegeville, PA 19426, USA. Electronic address: john.perez@pfizer.com. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20160201 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Hepatitis A Vaccines) RN - 0 (Meningococcal Vaccines) RN - 0 (Vaccines, Synthetic) SB - IM MH - Adolescent MH - Adult MH - Child MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - Hepatitis A Vaccines/administration & dosage MH - Humans MH - Internationality MH - Male MH - Meningococcal Infections/*prevention & control MH - Meningococcal Vaccines/*administration & dosage/*adverse effects MH - *Neisseria meningitidis, Serogroup B MH - Vaccines, Synthetic/administration & dosage/adverse effects MH - Young Adult OTO - NOTNLM OT - Adolescents OT - Bivalent rLP2086 OT - Meningitis OT - Safety OT - Vaccine EDAT- 2016/02/05 06:00 MHDA- 2016/10/08 06:00 CRDT- 2016/02/05 06:00 PHST- 2015/08/05 00:00 [received] PHST- 2016/01/14 00:00 [revised] PHST- 2016/01/19 00:00 [accepted] PHST- 2016/02/05 06:00 [entrez] PHST- 2016/02/05 06:00 [pubmed] PHST- 2016/10/08 06:00 [medline] AID - S0264-410X(16)00096-7 [pii] AID - 10.1016/j.vaccine.2016.01.044 [doi] PST - ppublish SO - Vaccine. 2016 Mar 14;34(12):1465-71. doi: 10.1016/j.vaccine.2016.01.044. Epub 2016 Feb 1.