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ACTIVE NOT RECRUITING
NCT05091619
PHASE3

A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Sponsor: China National Biotec Group Company Limited

View on ClinicalTrials.gov

Summary

The study will evaluate the safety, immunogenicity,immune persistence and lot-to-lot consistency of Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed, (DTacP) including 2 parts: PART 1 will evaluate the safety and immunogenicity of DTacP in health infants aged 2 months and 3 months compared with an adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine and Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine (PENTAXIM),compare the safety and immunogenicity of DTacP with different immunization schedules, and observe the immune persistence. PART 2 will evaluate the lot-to-lot consistency of DTacP in health infants aged 3 months with the 3-dose schedule of 3-4-5 month.

Official title: A Randomized, Blinded, Parallel Controlled Phase 3 Clinical Study to Evaluate the Safety and Immunogenicity of the Diphtheria, Tetanus and Three-components Acellular Pertussis Combined Vaccine, Adsorbed in Healthy Infants at the Age of 2 Months and 3 Months

Key Details

Gender

All

Age Range

2 Months - 3 Months

Study Type

INTERVENTIONAL

Enrollment

2898

Start Date

2021-10-22

Completion Date

2027-09-22

Last Updated

2025-09-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed

Intramuscular injection

BIOLOGICAL

Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed

Intramuscular injection

BIOLOGICAL

Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine

Intramuscular injection

Locations (4)

Neihuang County Center for Disease Control and Prevention

Anyang, Henan, China

Wen County Center for Disease Control and Prevention

Jiaozuo, Henan, China

Wuyang County Center for Disease Control and Prevention

Luohe, Henan, China

Yanjin County Center for Disease Control and Prevention

Xinxiang, Henan, China