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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
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
Conditions
Interventions
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.
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.
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