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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,820
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of PPV23 vaccine (0.5ml) on day 0
1 dose of Tdcp vaccine (0.5ml) on day 0
1 dose of DTaP vaccine (0.5ml) on day 0
Kaihua County Center for Disease Control and Prevention
Kaihua, China
Phase II: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase III: Geometric mean concentration (GMC) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: Pre-vaccination and 30 days post-vaccination
Phase III: Proportion of serum anti-DT and TT antibodies ≥ 0.1IU/ml
Time frame: 30 days after vaccination
Phase III: Incidence of adverse reactions
Time frame: Within 0-30 days after vaccination
Phase II: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase II: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase II: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase II: Incidence of serious stadverse events
Time frame: Within 6 months of vaccination
Phase III: Positive rate of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), FIM 2&3, Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibodies
Time frame: 30 days after vaccination
Phase III: Positive transfer rate of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Geometric Mean Increase (GMI) of serum anti-PT, FHA, PRN, FIM 2&3, DT, TT antibodies
Time frame: 30 days after vaccination
Phase III: Incidence of adverse events/reactions
Time frame: Within 30 minutes of vaccination
Phase III: Incidence of adverse events/reactions
Time frame: 0-7 days after vaccination
Phase III: Incidence of adverse events
Time frame: 0-30 days after vaccination
Phase III: Incidence of SAEs in subjects aged 7 years and older
Time frame: Within 6 months of vaccination
Phase III: Incidence of SAEs in subjects aged 6 years
Time frame: Within 12 months of vaccination
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