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RECRUITING
NCT06344065
PHASE3

Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants

Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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