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The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Full description
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.
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Inclusion criteria
Basic immune stage:
Enhanced immunity stage:
Exclusion criteria
Basic immune stage:
Enhanced immunity stage:
Primary purpose
Allocation
Interventional model
Masking
1,584 participants in 3 patient groups
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Central trial contact
Wenjian Fang
Data sourced from clinicaltrials.gov
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