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NOT YET RECRUITING
NCT07418372
PHASE1/PHASE2

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

Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Parallel-Controlled Phase I/II Clinical Trial Evaluating the Safety and Immunogenicity of Tetanus, Diphtheria and Acellular Component Pertussis Vaccine Adsorbed (Reduced Antigens Content) Among Individuals Aged 6 Years and Above

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2026-03-12

Completion Date

2027-07-31

Last Updated

2026-02-18

Healthy Volunteers

Yes

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

Locations (1)

Jiangjin District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China