drugset / Trial / NCT07203755
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This clinical trial is conducted in two parts. Part One employs a randomized, partially blinded, dose-escalation, partially active-controlled design. Part Two utilizes a randomized, blinded, placebo-controlled design. Part One is divided into four stages based on age and vaccine dose levels. Part Two consists of the 2-month-old vaccine/placebo groups.
Timeline
- Start
- 2025-12-19
- Primary completion
- 2029-02
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) | Unknown | 0.5 ml | — |
| Subject | DTcP-Hib-MCV4 | Vaccine | 0.5 ml | — |
| Comparator | Haemophilus influenzae type b (Conjugate) (Hib) | Unknown | 0.5 ml | — |
| Comparator | MCV4 | Vaccine | 0.5 ml | — |