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A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)
Sponsor: CanSino Biologics Inc.
Summary
This is a randomized, blinded, controlled phase II and III clinical trial evaluating the immunogenicity and safety of adsorbed cell-free DPT vaccine. 320 subjects aged 7 years and older in the phase II were divided into two age groups, the ≥18 years group and the 7-17 years group, and randomized 3:1 to receive the trial vaccine Tdcp versus the control vaccine PPV23. 1500 subjects in the phase III were divided into 3 age subgroups. 780 subjects were planned to be enrolled in the 6-year-old group and randomized 1:1 to receive the experimental vaccine Tdcp versus the control vaccine DTaP, and 360 subjects were planned to be enrolled in each of the 7-17 and ≥18 age groups and randomized 3:1 to receive the experimental vaccine Tdcp versus the control vaccine PPV23.
Official title: A Randomized, Blinded, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Adsorbed Cell-free DTP Vaccine (Five-component)
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1820
Start Date
2024-12-20
Completion Date
2025-05-30
Last Updated
2025-03-17
Healthy Volunteers
Yes
Conditions
Interventions
Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))
1 dose of Tdcp vaccine (0.5ml) on day 0
23-valent Pneumococcal Polysaccharide Vaccine (PPV23)
1 dose of PPV23 vaccine (0.5ml) on day 0
Tdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
Tdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
Tdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
PPV23
1 dose of PPV23 vaccine (0.5ml) on day 0
Tdcp
1 dose of Tdcp vaccine (0.5ml) on day 0
Diphtheria-tetanus-acellular pertussis vaccine (DTaP)
1 dose of DTaP vaccine (0.5ml) on day 0
Locations (1)
Kaihua County Center for Disease Control and Prevention
Kaihua, China