PMID- 29962480
OWN - NLM
STAT- MEDLINE
DCOM- 20190111
LR  - 20221207
IS  - 1884-2836 (Electronic)
IS  - 1344-6304 (Linking)
VI  - 71
IP  - 6
DP  - 2018 Nov 22
TI  - A Safety and Immunogenicity Study of a Single Dose of a Meningococcal (Groups A, 
      C, W, and Y) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MEN-ACWY-D) in 
      Healthy Japanese Participants.
PG  - 402-407
LID - 10.7883/yoken.JJID.2017.277 [doi]
AB  - Meningococcal disease can cause significant disability and mortality. The 
      quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine 
      (Men-ACWY-D) protects against invasive meningococcal disease caused by serogroups 
      A, C, W, and Y. This phase III, open-label, single-arm, multicenter study 
      evaluated the safety and immunogenicity of a single vaccine dose in healthy 
      Japanese adults. The study enrolled 200 participants between 2 and 55 years of 
      age. Immunogenicity was assessed by quantifying the seroprotection rates (the 
      proportion of participants with antibody titers >/= 1:128 against the capsular 
      polysaccharide from all 4 serogroups measured 28 days after vaccination). Safety 
      endpoints included occurrence, nature, time to onset, duration, intensity, 
      relationship to vaccination, and outcome of solicited and unsolicited adverse 
      events (AEs) and serious AEs (SAEs). Participants included 194 adults, 2 
      adolescents, and 4 children. Among adults, the seroprotection rates for 
      serogroups A, C, W, and Y were 91.2%, 80.2%, 89.1%, and 93.8%, respectively. 
      Seroconversion rates (the proportion of participants with pre-vaccination titers 
      of < 1:4 and a >/= 4-fold rise from baseline) were 87.3%, 83.0%, 94.4%, and 96.4%, 
      respectively. No immediate AEs, adverse reactions, SAEs, or deaths were reported 
      for any age group. Men-ACWY-D is well tolerated and immunogenic, eliciting 
      antibodies against capsular polysaccharides from all 4 serogroups in Japanese 
      adults.
FAU - Fukushima, Shinji
AU  - Fukushima S
AD  - Tokyo Medical University Hospital.
FAU - Kikuchi, Hitoshi
AU  - Kikuchi H
AD  - Meitetsu Hospital.
FAU - Miyazu, Mitsunobu
AU  - Miyazu M
AD  - Meitetsu Hospital.
FAU - Hamada, Atsuo
AU  - Hamada A
AD  - Tokyo Medical University Hospital.
FAU - Ouchi, Kazunobu
AU  - Ouchi K
AD  - Kawasaki Medical School.
FAU - Takagi, Hiroki
AU  - Takagi H
AD  - Sanofi K. K.
FAU - Mihara, Hanako
AU  - Mihara H
AD  - Sanofi K. K.
FAU - Sasaki, Toru
AU  - Sasaki T
AD  - Sanofi K. K.
FAU - Oka, Hayato
AU  - Oka H
AD  - Sanofi K. K.
FAU - Bosch-Castells, Valerie
AU  - Bosch-Castells V
AD  - Sanofi Pasteur.
FAU - Oster, Philipp
AU  - Oster P
AD  - Sanofi Pasteur.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20180629
PL  - Japan
TA  - Jpn J Infect Dis
JT  - Japanese journal of infectious diseases
JID - 100893704
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (MenACWY-D vaccine)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Polysaccharides, Bacterial)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antibodies, Bacterial/*blood
MH  - Asian People
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Healthy Volunteers
MH  - Humans
MH  - Immunization Schedule
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Middle Aged
MH  - Neisseria meningitidis/immunology
MH  - Polysaccharides, Bacterial/immunology
MH  - Seroconversion
MH  - Young Adult
OTO - NOTNLM
OT  - Japan
OT  - immunogenicity
OT  - meningococcal vaccines
OT  - safety
EDAT- 2018/07/03 06:00
MHDA- 2019/01/12 06:00
CRDT- 2018/07/03 06:00
PHST- 2018/07/03 06:00 [pubmed]
PHST- 2019/01/12 06:00 [medline]
PHST- 2018/07/03 06:00 [entrez]
AID - 10.7883/yoken.JJID.2017.277 [doi]
PST - ppublish
SO  - Jpn J Infect Dis. 2018 Nov 22;71(6):402-407. doi: 10.7883/yoken.JJID.2017.277. 
      Epub 2018 Jun 29.