drugset / Trial / NCT04099303
Phase I Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed .
Phase 1
Completed
400 enrolled
CanSino Biologics Inc.
Henan Center for Disease Control and Prevention · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using of the vaccine targeted the three components, it greatly reduced incidence of the three kinds of diseases. The Purpose of this study is to preliminary evaluate the safety of DTcP compared to adsorbed diphtheria and tetanus combined vaccine （DT），Diphtheria-tetanus-acellular pertussis vaccine（DTaP） or PENTAXIM（DTaP-IPV-Hib） in participants.
Timeline
- Start
- 2020-04-28
- Primary completion
- 2021-10-27
- Completion
- 2021-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Diphtheria and Tetanus Combined Vaccine, Adsorbed | Vaccine | 2 ml | Intramuscular |
| Subject | Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Diphtheria-tetanus-acellular pertussis vaccine | Vaccine | 0.5 ml | Intramuscular |