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

NCT06056050 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

  • Diphtheria
  • Tetanus
  • Pertussis

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

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-04-13
Completion
2025-09-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06056050 on ClinicalTrials.gov