PMID- 33270487
OWN - NLM
STAT- MEDLINE
DCOM- 20240223
LR  - 20240223
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 17
IP  - 3
DP  - 2021 Mar 4
TI  - Safety and immunogenicity of meningococcal (Groups A and C) polysaccharide 
      vaccine in children 2 to 6 y of age in China: a randomized, active-controlled, 
      non-inferiority study.
PG  - 919-926
LID - 10.1080/21645515.2020.1801077 [doi]
AB  - Meningococcal serogroups A and C cause significant numbers of cases in China. The 
      Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed 
      in China in 1995. Immunogenicity and safety of a single dose of Men-AC against a 
      similar marketed vaccine, the Lanzhou Institute serogroups A and C vaccine 
      (Lanzhou-AC), were evaluated in children 2 to 6 y of age. Antibody titers were 
      determined before and on Day 30 after vaccination using a serum bactericidal 
      assay using baby rabbit complement (SBA-BR). Immunogenicity endpoints included 
      rates of seroconversion (postvaccination antibody titers >/=4-fold higher) and 
      seroprotection (postvaccination titers >/=1:8). Unsolicited systemic adverse events 
      (AEs) within 30 minutes after vaccination, solicited injection site and systemic 
      reactions between Days 0 and 7, unsolicited non-serious AEs within 30 d, and 
      serious adverse events (SAEs) throughout were recorded. Seroconversion rates 
      against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) 
      and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% 
      CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC 
      group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% 
      CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) 
      and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group. 
      Non-inferiority of Men-AC with regard to immunogenicity was demonstrated since 
      the lower bounds of the 95% CIs of the differences in rates between the two 
      groups were > -5% for both serogroups. Both vaccines were well tolerated.
FAU - Zhu, Feng-Cai
AU  - Zhu FC
AD  - NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center 
      for Disease Prevention and Control, Nanjing, Jiangsu Province, China.
FAU - Hu, Yue-Mei
AU  - Hu YM
AD  - NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center 
      for Disease Prevention and Control, Nanjing, Jiangsu Province, China.
FAU - Li, Ya-Nan
AU  - Li YN
AD  - National Institutes for Food and Drug Control, Beijing, China.
FAU - Shu, Jean-Denis
AU  - Shu JD
AD  - China Medical Affairs, Sanofi Pasteur China, Beijing, China.
FAU - Oster, Philipp
AU  - Oster P
AD  - Sanofi Pasteur, Lyon, France.
LA  - eng
PT  - Equivalence Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201203
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Animals
MH  - Rabbits
MH  - Antibodies, Bacterial
MH  - China
MH  - *Meningococcal Infections/prevention & control
MH  - *Meningococcal Vaccines/adverse effects
MH  - *Neisseria meningitidis
MH  - Vaccines, Conjugate
MH  - Humans
MH  - Child, Preschool
MH  - Child
MH  - Equivalence Trials as Topic
PMC - PMC7993220
OTO - NOTNLM
OT  - China
OT  - Meningococcal Polysaccharide Vaccine
OT  - immunogenicity
OT  - meningococcal Serogroup A
OT  - meningococcal Serogroup C
OT  - safety
EDAT- 2020/12/04 06:00
MHDA- 2021/06/24 06:00
PMCR- 2020/12/03
CRDT- 2020/12/03 17:13
PHST- 2020/12/04 06:00 [pubmed]
PHST- 2021/06/24 06:00 [medline]
PHST- 2020/12/03 17:13 [entrez]
PHST- 2020/12/03 00:00 [pmc-release]
AID - 1801077 [pii]
AID - 10.1080/21645515.2020.1801077 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2021 Mar 4;17(3):919-926. doi: 
      10.1080/21645515.2020.1801077. Epub 2020 Dec 3.