title: Safety and immunogenicity of a single dose of a quadrivalent meningococcal conjugate vaccine (MenACYW-D): a multicenter, blind-observer, randomized, phase III clinical trial in the Republic of Korea.
abstract: OBJECTIVE
  To assess the safety and immunogenicity of a meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) in a Korean population.
  
  
  METHODS
  This was a phase III, blind-observer, controlled study in which participants aged 11-55 years were randomized (2:1 ratio) to a single dose of MenACYW-D or tetanus/diphtheria/acellular pertussis (Tdap) vaccine. Outcomes included rates of seroconversion against all serogroups (≥4-fold increase in antibody titer from pre-vaccination), geometric mean titers (GMTs) at days 0 and 28 based on a serum bactericidal assay using baby rabbit complement, rates of seroprotection (titer ≥1:128) at day 28, and safety.
  
  
  RESULTS
  A total of 300 participants were enrolled in the study (200 MenACYW-D and 100 Tdap). Seroconversion rates for serogroups A, C, Y, and W-135 were 77.8%, 88.3%, 74.6%, and 92.4%, respectively, for the MenACYW-D group and 9.3%, 8.1%, 12.2%, and 8.2%, respectively, for the Tdap group. The proportions of participants with pre-vaccination titers ≥1:128 were 57.3%, 12.6%, 51.5%, and 22.2% for serogroups A, C, Y, and W-135, respectively; post-vaccination rates were 98.5%, 89.4%, 96.0%, and 95.0% for the MenACYW-D group. A lower proportion of participants reported solicited reactions with MenACYW-D (46.2%) compared with Tdap (76.8%).
  
  
  CONCLUSIONS
  A single dose of MenACYW-D was well tolerated and elicited a robust immune response in Korean adolescents and adults.
authors.affiliation: Yonsei University College of Medicine Severance Children's Hospital, Seoul, Republic of Korea.
authors.forename: Dong Soo
authors.initials: DS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Korea University Anam Hospital, 73 Inchon-ro, Seongbuk-gu, Seoul 136-705, Republic of Korea. Electronic address: macropha@korea.ac.kr.
authors.forename: Min Ja
authors.initials: MJ
authors.lastname: Kim
authors.affiliation: Kyung Hee University Hospital, Seoul, Republic of Korea.
authors.forename: Sung-Ho
authors.initials: SH
authors.lastname: Cha
authors.affiliation: Yonsei University Wonju College of Medicine, Kangwon-do, Republic of Korea.
authors.forename: Hwang Min
authors.initials: HM
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Gyeonggi-do, Republic of Korea.
authors.forename: Jong-Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Hallym University Sacred Heart Hospital, Gyeonggi-do, Republic of Korea.
authors.forename: Kwang Nam
authors.initials: KN
authors.lastname: Kim
authors.affiliation: Inha University School of Medicine, Incheon, Republic of Korea.
authors.forename: Jin-Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jun Yong
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Sanofi Pasteur, Lyon, France.
authors.forename: Valérie Bosch
authors.initials: VB
authors.lastname: Castells
authors.affiliation: Sanofi Pasteur, Seocho-gu, Seoul, Republic of Korea.
authors.forename: Hee Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Sanofi Pasteur, Seocho-gu, Seoul, Republic of Korea.
authors.forename: Joon
authors.initials: J
authors.lastname: Bang
authors.affiliation: Sanofi Pasteur, Lyon, France.
authors.forename: Philipp
authors.initials: P
authors.lastname: Oster
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D008875:Middle Aged; D056910:Republic of Korea; D000069078:Seroconversion; D065288:Serogroup; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate
keywords: Immunogenicity; MenACYW–D; Meningococcal vaccine; Republic of Korea; Safety