[Evaluation on the safety of a group A + C meningococcal polysaccharide vaccine].
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.
Dong
Bai-qing
BQ
Guangxi Center for Disease Prevention and Control, Nanning 530021, China.
Ye
Qiang
Q
Cui
Xuan-lin
XL
Yang
Jin
J
Gong
Jian
J
Yang
Ming
M
Liao
He-zhuang
HZ
Wei
Shi-liang
SL
Zhang
Jie
J
Wu
Xing-hua
XH
Si
Guo-ai
GA
Yang
Hong-hui
HH
Tsuzuki
Ataru
A
Park
JinKyung
J
Ali
Mohammad
M
Ochiai
Leon R
LR
Clemens
John D
JD
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
D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; C043226:meningococcal group A polysaccharide; C037676:meningococcal group C polysaccharide