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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,584

Participants

Timeline

Start Date

December 21, 2023

Primary Completion Date

May 25, 2025

Study Completion Date

December 25, 2028

Conditions
Healthy Volunteers
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.

Trial Locations (1)

530028

RECRUITING

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning

All Listed Sponsors
lead

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

INDUSTRY