PMID- 25075804
OWN - NLM
STAT- MEDLINE
DCOM- 20150330
LR  - 20220409
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 32
IP  - 40
DP  - 2014 Sep 8
TI  - Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY 
      vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open 
      label study.
PG  - 5177-84
LID - S0264-410X(14)01015-9 [pii]
LID - 10.1016/j.vaccine.2014.07.063 [doi]
AB  - BACKGROUND: MenACWY-CRM (Menveo(R), Novartis Vaccines, Siena, Italy) is a 
      quadrivalent meningococcal conjugate vaccine developed to help prevent invasive 
      meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. 
      It is approved within the European Union in persons >2 years of age and in 
      persons from 2 months to 55 years of age in the United States, among other 
      countries. Little is known about the immunogenicity and safety of this vaccine in 
      Taiwanese children >2 years and adolescents. This study assessed the 
      immunogenicity and safety of a single injection of MenACWY-CRM vaccine in 
      Taiwanese subjects aged 2-18 years old. METHODS: In this phase III, multicentre, 
      open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity 
      measures were rates of seroresponse (defined as the proportion of subjects with a 
      postvaccination hSBA >/=1:8 if the prevaccination (baseline) titre was <1:4, or at 
      least a fourfold higher hSBA titre than baseline if the prevaccination titre was 
      >/=1:4), percentages of subjects with serum bactericidal activity (hSBA) >/=1:8 for 
      serogroups A, C, W and Y and hSBA geometric mean titres (GMTs). Local and 
      systemic reactions and all adverse events (AEs) were recorded for 7 days, and 
      medically attended AEs for 1 month post-vaccination. RESULTS: Seroresponse rates 
      after MenACWY-CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 
      83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with 
      hSBA >/=1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, 
      respectively. GMTs against all serogroups rose by >/=7-fold from baseline to Day 
      29. The vaccine was well tolerated. CONCLUSIONS: A single dose of MenACWY-CRM 
      demonstrated a robust immune response, and an acceptable safety profile in 
      Taiwanese children and adolescents.
CI  - Copyright (c) 2014 Elsevier Ltd. All rights reserved.
FAU - Huang, Li-Min
AU  - Huang LM
AD  - Department of Pediatrics, National Taiwan University Hospital, No. 8, Chung-Shan 
      S. Rd., Taipei 10048, Taiwan.
FAU - Chiu, Nan-Chang
AU  - Chiu NC
AD  - Department of Pediatrics, Mackay Memorial Hospital, No. 92, Sec. 2, Chung-Shan N. 
      Rd., Taipei 10449, Taiwan.
FAU - Yeh, Shu-Jen
AU  - Yeh SJ
AD  - Far Eastern Memorial Hospital, No. 21, Nan-Ya S. Rd., Sec. 2, Pan-Chiao, Taipei 
      22060, Taiwan.
FAU - Bhusal, Chiranjiwi
AU  - Bhusal C
AD  - Novartis Vaccines and Diagnostics, Srl., Siena, Italy.
FAU - Arora, Ashwani Kumar
AU  - Arora AK
AD  - Novartis Vaccines and Diagnostics, Srl., Siena, Italy. Electronic address: 
      ashwani_kumar.arora@novartis.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01410474
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140727
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (MenACWY-CRM vaccine)
RN  - 0 (Meningococcal Vaccines)
SB  - IM
MH  - Adolescent
MH  - Blood Bactericidal Activity
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Humans
MH  - Male
MH  - Meningococcal Infections/*prevention & control
MH  - Meningococcal Vaccines/administration & dosage/*therapeutic use
MH  - Taiwan
OTO - NOTNLM
OT  - Adolescents
OT  - Children
OT  - Immunogenicity
OT  - Meningococcal disease
OT  - Quadrivalent conjugate vaccine
OT  - Safety
EDAT- 2014/07/31 06:00
MHDA- 2015/03/31 06:00
CRDT- 2014/07/31 06:00
PHST- 2014/03/31 00:00 [received]
PHST- 2014/06/21 00:00 [revised]
PHST- 2014/07/17 00:00 [accepted]
PHST- 2014/07/31 06:00 [entrez]
PHST- 2014/07/31 06:00 [pubmed]
PHST- 2015/03/31 06:00 [medline]
AID - S0264-410X(14)01015-9 [pii]
AID - 10.1016/j.vaccine.2014.07.063 [doi]
PST - ppublish
SO  - Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 
      Jul 27.