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A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)
Sponsor: CanSino Biologics Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Months - 3 Months
Study Type
INTERVENTIONAL
Enrollment
2520
Start Date
2023-08-11
Completion Date
2025-04-01
Last Updated
2025-03-17
Healthy Volunteers
Yes
Interventions
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.
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.
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.
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.
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.
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.
Locations (1)
Changge Center for Disease Control and Prevention
Xuchang, Henan, China