Vaccination Clinical Trial
Official title:
A Randomized, Controlled, Multicenter Vaccine Clinical Trial to Evaluate The Safety and Immunogenicity of Combined Immunization With sIPV and DTaP
Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous
immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity
and safety studies should also be conducted. Currently in China the vaccination schedules of
sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the
vaccination time conflict and explore the possibility of simultaneous vaccination, we design
this clinical study of simultaneous vaccination of the two vaccines.
To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd
doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old
; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP
at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days
after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate
the seroprotection rates and antibody geometric mean concentrations. The safety of both
immunization schedule will be monitored as well.
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