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RECRUITING
NCT07891104
PHASE1/PHASE2

A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed

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

View on ClinicalTrials.gov

Summary

This is a randomized, positive-controlled phase I/II clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed in subjects aged 2 Months to 6 Years.

Official title: A Randomized, Positive-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed in Individuals Aged 2 Months to 6 Years

Key Details

Gender

All

Age Range

2 Months - 6 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2026-10-11

Completion Date

2028-09-25

Last Updated

2026-10-23

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed

Dosage and immunization schedule: 0.5 mL/dose. 18 months to 6 years: one dose at Day 0. 2 months: three doses for basic immunization at 2, 3, and 4 months of age, or at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.

BIOLOGICAL

Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine

Dosage and immunization schedule: 0.5 mL/dose.18 months to 6 years: one dose at Day 0. 2 months: three doses for basic immunization at 3, 4, and 5 months of age, or at 2, 3, and 4 months of age, or at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.

BIOLOGICAL

Diphtheria, Tetanus and Acellular Component Pertussis Combined Vaccine+Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Dosage and immunization schedule: 0.5 mL/dose.18 to 24 months : one dose at Day 0. 2 months: three doses for basic immunization at 2, 4, and 6 months of age, and one dose for booster immunization at 18 to 24 months of age.

Locations (3)

Hechuan District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China

Jiulongpo District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China

Yongchuan District Center for Disease Control and Prevention

Chongqing, Chongqing Municipality, China