The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
This is a Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and immunogenicity of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old infants. Expected to include 1584 3-month-old infants. Among them, 1056 infants were randomly assigned to the experimental group and active control group 1, and 528 infants were included in active control group 2. Select the top 200 subjects with study numbers from the experimental group as immunological persistence follow-up subset.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,584
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for experimental vaccine is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 1 is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China
RECRUITINGImmunogenicity results of experimental group and active control group (DTaP)
Positive conversion rate (4-fold increase) of antibodies against diphtheria (anti D) and tetanus (anti T)
Time frame: 30 days after basic immunization
Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T)
Positive conversion rate (4-fold increase) of pertussis toxin antibody (anti PT), pertussis filamentous hemagglutinin antibody (anti FHA) antibodies
Time frame: 30 days after basic immunization
Immunogenicity results of experimental group
Positive conversion rate of pertussis adhesin antibody (anti PRN)
Time frame: 30 days after basic immunization
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Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 2 is through intramuscular injection of 0.5ml into the anterolateral side of the thigh or the upper arm.