[Study on the safety and immunogenicity of group A + C meningococcal polysaccharide vaccine].
OBJECTIVE
In order to evaluate the safety and immunogenicity of group A + C meningococcal polysaccharide vaccine, a controlled field trial was performed among children at 6-24 months and 5-13 years old in Longsheng county, Guangxi Zhuang Autonomous Region.


METHODS
More than 600 children were selected in this trial. 428 children, aged 6-24 month-old and 5-13 year-old were involved in two experimental groups and were inoculated 100 microg of group A + C meningococcal polysaccharide vaccine. 103 children in positive control group were inoculated 50 microg of group A meningococcal polysaccharide vaccine while 94 children in negative control group were inoculated 30 microg of Typhoid Vi polysaccharide vaccine. Both systemic and local reactions were observed in each group at 6 h,24 h,48 h and 72 h after inoculation. Blood samples were collected in all children before and at 1 month after inoculation. Additionally, at least 50 blood samples were taken in each experimental group at 6 and 12 months after inoculation. Serum bactericidal antibody was tested by micro bactericidal test.


RESULTS
Both systemic and local reactions were mild in two experimental groups with only 3 children (0.7%) had > or = 37. 6 degrees C fever, 4 children (0.9%) appeared mild areola but all adverse reaction disappeared within 48 hours. In 5-13 year-old experimental group, the rates for four-fold increase of bactericidal antibody were 96.59% and 92.15% to group A and group C meningococcus respectively at 1 month after inoculation, and remained 90.91% and 90.08% at 12 months after inoculation.


CONCLUSIONS
Group A + C meningococal polysaccharide vaccine was safe and having good immunogenicity among Chinese children.
He
Li
L
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Li
Rong-cheng
RC
Li
Ya-nan
YN
Huang
Yun-neng
YN
Yao
Qun
Q
Yuan
Zeng-lin
ZL
Li
Feng-xiang
FX
Cui
Xuan-lin
XL
Nong
Yi
Y
Yang
Ming
M
D000293:Adolescent; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology*; D014436:Typhoid-Paratyphoid Vaccines / Q000009:adverse effects / Q000276:immunology
D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; D014436:Typhoid-Paratyphoid Vaccines; C057664:Vi polysaccharide vaccine, typhoid; C043226:meningococcal group A polysaccharide; C037676:meningococcal group C polysaccharide