Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05951725
PHASE3

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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

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.

Locations (1)

Changge Center for Disease Control and Prevention

Xuchang, Henan, China