[Safety and immunogenicity of split vaccines of influenza viruses].
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi
; 18(3): 207-9, 2004 Sep.
Article
in Zh
| MEDLINE
| ID: mdl-15640848
ABSTRACT
OBJECTIVE:
To evaluate the safety and immunogenicity of influenza split vaccine.METHODS:
According to the criteria of No.2002SL0043, instruction of application for new drug in clinical trial issued by the State Food and Drug Administration, 876 healthy persons were divided at random into vaccine group and control group. The trial was performed with the double blind method. Local and systemic adverse reactions were observed within 3 days after the vaccine group subjects were vaccinated. The antibody response to vaccines was detected with hemagglutination inhibition (HI) test. Numbers of seroconversions and HI titers greater than or equal to 40, as well as the mean geometric titer increase in HI were analyzed.RESULTS:
There was no significant difference in local and systemic adverse reaction between vaccine and control groups. Meanwhile there was also no significant difference in seroconversions and protective level between two groups. However, there was obvious difference in mean geometric titer increase of antibody against H1N1 virus, while there was no significant difference in that of antibodies to H3N2 and type B viruses.CONCLUSIONS:
The safety and immunogenicity of both vaccines are excellent.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Influenza A virus
/
Influenza B virus
/
Influenza Vaccines
/
Influenza, Human
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Child, preschool
/
Humans
/
Infant
/
Middle aged
Language:
Zh
Journal:
Zhonghua Shi Yan He Lin Chuang Bing Du Xue Za Zhi
Journal subject:
VIROLOGIA
Year:
2004
Document type:
Article
Affiliation country:
China