The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
528
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
Chunan Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Longyou Center for Disease Control and Prevention
Quzhou, Zhejiang, China
seroconversion rate
any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies.
Time frame: seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine.
safety: rate of adverse events
the rate of adverse events.
Time frame: At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data.
neutralizing antibody titer
Time frame: Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine.
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