NCT05951725

A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)

A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,520 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 2 Months – 3 Months
• Healthy volunteers: Accepted

Summary

The combined pertussis, diphtheria and tetanus vaccine, the first vaccine to be included in the Expanded Programme of Immunization(EPI) of World Health Organization(WHO), has played an important role in the prevention and control of these three infectious diseases. The (diphtheria，tetanus and acellular pertussis combined vaccine，DTaP) vaccine was successfully developed in China in 1993, and its safety and serological effects were confirmed by the observation of human safety, with mild vaccination reactions and good immunization effects.The (Diphtheria-tetanus-component acellular pertussis vaccine, DTcP) vaccine is suitable for immunization against pertussis, diphtheria and tetanus infections in people between 2 and 24 months of age.

Conditions

• Diphtheria, Tetanus and Acellular Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP)	Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
BIOLOGICAL	Diphtheria，Tetanus and Acellular Pertussis Combined Vaccine，DTaP	Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
BIOLOGICAL	Diphtheria,tetanus,pertussis(acellular,component),Inactivated polio vaccine(adsorbed）and Haemophilus influenzae type b conjugate vaccine,adsorbed,DTaP-IPV-Hib	Three doses of basic immunization were completed at 3, 4 and 5 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
BIOLOGICAL	DTcP	Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
BIOLOGICAL	DTaP-IPV-Hib	Three doses of basic immunization were completed at 2, 3 and 4 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.
BIOLOGICAL	DTcP	Three doses of basic immunization were completed at 2, 4 and 6 months of age, and one dose of booster immunization was completed at 18 to 24 months of age.

Timeline

• Start date: 2023-08-11
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-07-19
• Last updated: 2025-03-17

Locations

1 site across 1 country: China