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ACTIVE NOT RECRUITING
NCT06708286
PHASE2/PHASE3

A Clinical Trials of Adsorbed Cell-free DPT Vaccine (Five-component)

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Tdcp))

1 dose of Tdcp vaccine (0.5ml) on day 0

BIOLOGICAL

23-valent Pneumococcal Polysaccharide Vaccine (PPV23)

1 dose of PPV23 vaccine (0.5ml) on day 0

BIOLOGICAL

Tdcp

1 dose of Tdcp vaccine (0.5ml) on day 0

BIOLOGICAL

PPV23

1 dose of PPV23 vaccine (0.5ml) on day 0

BIOLOGICAL

Tdcp

1 dose of Tdcp vaccine (0.5ml) on day 0

BIOLOGICAL

PPV23

1 dose of PPV23 vaccine (0.5ml) on day 0

BIOLOGICAL

Tdcp

1 dose of Tdcp vaccine (0.5ml) on day 0

BIOLOGICAL

PPV23

1 dose of PPV23 vaccine (0.5ml) on day 0

BIOLOGICAL

Tdcp

1 dose of Tdcp vaccine (0.5ml) on day 0

BIOLOGICAL

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