MedTrace Logo

Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine

NCT07418372 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2026-02-18

No results posted yet for this study

Summary

This is a randomized, double-blinded, parallel-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (reduced antigen content) in subjects aged 6 years and above.

Conditions

  • Tetanus, Diphtheria and Acellular Pertussis Vaccination
  • Tetanus
  • Diphtheria
  • Pertussis
  • Pertussis Vaccines

Interventions

BIOLOGICAL

low-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)

Low-dose vaccine, 0.5ml/dose, one dose at Day 0

BIOLOGICAL

high-dose Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content)

High-dose vaccine, 0.5ml/dose, one dose at Day 0

BIOLOGICAL

Tetanus, Diphtheria and Acellular Pertussis Vaccine

DTaP controlled vaccine, 0.5ml/dose, one dose at Day 0

BIOLOGICAL

23-valent polysaccharide pneumococcal vaccine

PPV23 controlled vaccine, 0.5ml/dose, one dose at Day 0

Sponsors & Collaborators

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jiawei Xu · Chongqing Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2026-08-31
Completion
2027-07-31

Countries

  • China

Study Locations

More Related Trials

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 NCT07418372 on ClinicalTrials.gov