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Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Summary
The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.
Official title: A Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial to Evaluate the Immunogenicity and Safety of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old Infants
Key Details
Gender
All
Age Range
3 Months - 3 Months
Study Type
INTERVENTIONAL
Enrollment
1584
Start Date
2023-12-21
Completion Date
2028-12-25
Last Updated
2024-04-03
Healthy Volunteers
Yes
Conditions
Interventions
Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed)
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for experimental vaccine is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed)
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 1 is intramuscular injection of 0.5ml into the lateral deltoid muscle of the upper arm.
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine
Three doses of basic immunization were administered at 3, 4, and 5 months of age, and one dose of booster immunization was administered at 18-24 months of age, for a total of four doses. The administration route for active control vaccine 2 is through intramuscular injection of 0.5ml into the anterolateral side of the thigh or the upper arm.
Locations (1)
Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention
Nanning, Guangxi, China