title: [Evaluation on the safety of a group A + C meningococcal polysaccharide vaccine].
abstract: OBJECTIVE
  To evaluate the safety of a group A + C meningococcal polysaccharide vaccine as part of a phase IV clinical trial.
  
  
  METHODS
  The study area was divided into 108 clusters according to the principle of cluster randomization, stratified and paired sampling methods. 54 out of 108 clusters served as observation groups were administered A + C vaccine, while the rest 54 groups were administered Vi polysaccharide vaccine. An adverse event surveillance system was established to monitor the adverse events following the vaccination campaign. Identical form and methods were used for data collection to investigate the adverse events following the vaccination of both A+ C vaccine and Vi vaccine.
  
  
  RESULTS
  34,543 people were vaccinated, including 18,167 of whom received A + C vaccine, while the other 16,376 received Vi vaccine. The rates of immediate injection reaction and unsolicited non-serious adverse events from A + C vaccine group were 0.44% and 0.38% while of Vi vaccine group were 0.79% and 0.73% respectively. At the solicited adverse event survey on 3-day-post-vaccination, 1239 vaccinees were followed-up including 771 received A + C vaccine and 468 received Vi vaccine. The local injection reaction rate of A + C vaccine group on the 1st day was significantly higher (X2 = 13.98, P = 0.0002) than that of Vi vaccine group. Neither the local injection reaction rate nor the system reaction rate between both groups was significantly different on 2nd and 3rd day, post vaccination. It was not statistically different when comparing fever onset rate between those who received vaccine and those who did not, in each vaccine group. There were no serious adverse events observed.
  
  
  CONCLUSIONS
  Results showed that the side effects of A + C vaccine and the Vi vaccine were mild and safe for vaccination campaigns targeting on populations at different age.
authors: Guangxi Center for Disease Prevention and Control, Nanning 530021, China.
authors: Bai-qing
authors: BQ
authors: Dong
authors: Qiang
authors: Q
authors: Ye
authors: Xuan-lin
authors: XL
authors: Cui
authors: Jin
authors: J
authors: Yang
authors: Jian
authors: J
authors: Gong
authors: Ming
authors: M
authors: Yang
authors: He-zhuang
authors: HZ
authors: Liao
authors: Shi-liang
authors: SL
authors: Wei
authors: Jie
authors: J
authors: Zhang
authors: Xing-hua
authors: XH
authors: Wu
authors: Guo-ai
authors: GA
authors: Si
authors: Hong-hui
authors: HH
authors: Yang
authors: Ataru
authors: A
authors: Tsuzuki
authors: JinKyung
authors: J
authors: Park
authors: Mohammad
authors: M
authors: Ali
authors: Leon R
authors: LR
authors: Ochiai
authors: John D
authors: JD
authors: Clemens
mesh_terms: D000293:Adolescent; D000328:Adult; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D008875:Middle Aged; D011135:Polysaccharides, Bacterial / Q000276:immunology*; D017678:Sex Distribution; D055815:Young Adult
chemical_list: D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; C043226:meningococcal group A polysaccharide; C037676:meningococcal group C polysaccharide