This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Chengdu Institute of Biological Products Co., Ltd. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28\~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
480
vaccinate with DTaP
vaccinate with DT
Fuyang Center for Disease Control and Prevention
Hangzhou, Zhejiang, China
Tongxiang Center for Disease Control and Prevention
Jiaxing, Zhejiang, China
Seroconversion rates of the vaccination
Defined as any positive antibody response against pertussis,diphtheria,tetanus in children who were seronegative prior to the vaccination, or at least a fourfold increase in antibody levels against pertussis for children who had pre-existing positive antibodies
Time frame: 28-42 days after the dose of DTaP or DT
Seropositive rates after the vaccination
The percentage of participants with positive antibody against pertussis,diphtheria and tetanus.
Time frame: 28-42 days after the dose of DTaP or DT
Safety of the DTaP or DT vaccine immunization
The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT
Time frame: 28 days after the vaccination
Geometric mean antibody concentrations before the vaccination
The GMC against pertussis,diphtheria and tetanus
Time frame: before the dose of DTaP or DT
Geometric mean antibody concentrations after the vaccination
The GMC against pertussis,diphtheria and tetanus
Time frame: 28-42 days after the dose of DTaP or DT
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