NCT06344065

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,584 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 3 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants.

Detailed description

This is a Phase III, Single Center, Randomized, Blind, and Positive Control Clinical Trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and immunogenicity of Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed) in 3-month-old infants. Expected to include 1584 3-month-old infants. Among them, 1056 infants were randomly assigned to the experimental group and active control group 1, and 528 infants were included in active control group 2. Select the top 200 subjects with study numbers from the experimental group as immunological persistence follow-up subset.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-05-25
• Completion: 2028-12-25
• First posted: 2024-04-03
• Last updated: 2024-04-03

Locations

1 site across 1 country: China