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ACTIVE NOT RECRUITING
NCT06056050
PHASE1

A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

Summary

Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, diphtheria is an acute upper respiratory infectious disease caused by Gram-positive Corynebacterium diphtheriae, and tetanus is a highly fatal disease caused by Clostridium tetani infection. Currently, there is no clinical trial registration of Diphtheria, tetanus, and pertussis (DPT) vaccine applicable to ≥6 years of age in China, therefore, the five-component acellular DPT combination vaccine developed by our research has a promising future.

Official title: A Randomized, Blinded, Controlled Phase I Clinical Trial for Preliminary Evaluation of the Safety and Immunogenicity of Adsorbed Cell-free DPT Vaccine (for People Aged 6 Years and Above)

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2023-12-06

Completion Date

2025-09-28

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Tetanus, Reduced Diphtheria and Acellular Pertussis (Five Components) Combined Vaccine, Adsorbed (Aged 6 Years and Older) (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

Diphtheria and Tetanus Combined Vaccine, Adsorbed (DT)

1 dose of DT vaccine (0.5ml) on Day 0

Locations (1)

Shaanxi Center for Disease Control and Prevention

Xi'an, Shaanxi, China