Trials / Recruiting
RecruitingNCT07203755
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
A Randomized, Partially Blinded, Dose-Exploratory, Active/Placebo-Controlled Phase I Clinical Trial Evaluating the Safety and Immunogenicity of the Adsorbed Acellular Pertussis (Tricomponent) DPT-Hib (Conjugate)-ACYW135-Group B Meningococcal (Conjugate) Combined Vaccine in Individuals Aged 2 Months to 6 Years
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- CanSino Biologics Inc. · Industry
- Sex
- All
- Age
- 2 Months – 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Diphtheria, Tetanus and Acellular Pertussis
- Epidemic Meningitis
- Haemophilus Influenzae Type B Infection
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | DTcP-Hib-MCV4 | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | DTcP-Hib-MCV4 | 1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0 |
| BIOLOGICAL | DTcP-Hib-MCV4 | 3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| BIOLOGICAL | DTcP-Hib-MCV4 | 3 doses of DTcP-Hib-MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| BIOLOGICAL | Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) | 3 doses of DTcP (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| BIOLOGICAL | Haemophilus influenzae type b (Conjugate) (Hib) | 3 doses of Hib (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| BIOLOGICAL | Meningococcal Group ACYW135 (Conjugate) (MCV4) | 3 doses of MCV4 (0.5ml) at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. |
| BIOLOGICAL | MCV4 | 3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age. |
| BIOLOGICAL | MCV4 | 3 doses of MCV4 (0.5ml) at 0, 2, and 4 months. |
| OTHER | Sodium Chloride Injection (0.9%) (Saline Solution) (NS) | 3 doses of NS (0.5ml) at 0, 2, and 4 months. |
Timeline
- Start date
- 2025-12-19
- Primary completion
- 2029-02-01
- Completion
- 2029-02-01
- First posted
- 2025-10-02
- Last updated
- 2025-12-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07203755. Inclusion in this directory is not an endorsement.