[Safety and immunogenicity of rabies vaccine (chick embryo cell) for human use produced in Germany and India].
OBJECTIVE
To evaluate the safety and immunogenicity of Rabipur produced in India.


METHODS
A random and single-blind study was conducted to compare the safety, effect and sero conversion rates. Rabipur produced in Germany used as control group.


RESULTS
The results showed that they were no severe systemic and local reaction occurred in trial group (Rabipur produced in India). The difference between trial group and control group was not significant. 14 day and 45 days after the first dose, the seroconversion rates of the two groups were 100%. 14 day and 45 days after the first dose, GMC of the two groups increased obviously and highly beyond 0.5TU/ml.


CONCLUSIONS
Rabipur produced in India has excellent safety and immunogenicity. Trial Registration National Food Drugs Surveillance Administrative Bureau, "Medicine Clinical Experiment Written directive from a superior" 2005L04184.
Zhu
Feng-Cai
FC
Jiangsu Provincial Center for Diseasial Control and Prevention, Nanjing 210009, Jiangsu, China.
Wu
Chuan-Hong
CH
Meng
Fan-Yue
FY
D000293:Adolescent; D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000276:immunology; D002642:Chick Embryo; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005858:Germany; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011818:Rabies / Q000276:immunology* / Q000517:prevention & control / Q000821:virology; D011819:Rabies Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011820:Rabies virus / Q000276:immunology; D055815:Young Adult
D000914:Antibodies, Viral; D011819:Rabies Vaccines