Trials / Active Not Recruiting
Active Not RecruitingNCT05091619
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,898 (actual)
- Sponsor
- China National Biotec Group Company Limited · Industry
- Sex
- All
- Age
- 2 Months – 3 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-10-22
- Primary completion
- 2024-01-22
- Completion
- 2027-09-22
- First posted
- 2021-10-25
- Last updated
- 2025-09-15
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05091619. Inclusion in this directory is not an endorsement.