Actively Recruiting
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Led by CanSino Biologics Inc. · Updated on 2025-12-31
260
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years old
- Legal guardians willing to provide identification and sign informed consent
- Able to comply with clinical trial requirements
- Individuals 18-24 months who completed 3-dose DTaP and meningococcal primary series but no DTaP booster
- Children 6 years old who completed 4 doses of DTaP but not the 5th dose and only the first meningococcal booster dose
You will not qualify if you...
- Infants born prematurely before 37 weeks or with low birth weight (<2500g) at 2 or 3 months
- History of abnormal labor, asphyxia needing resuscitation, or neurological impairment at 2 or 3 months
- Severe congenital malformations, developmental disorders, genetic defects, or severe malnutrition
- Severe allergic reactions or anaphylaxis to vaccines
- History or family history of epilepsy, convulsions, cerebral palsy, psychiatric disorders, or progressive neurological diseases
- Diagnosed with immunodeficiency, HIV, lymphoma, leukemia, autoimmune diseases
- Acute illness or worsening chronic disease within 3 days before vaccination
- Severe chronic diseases like respiratory, cardiovascular, liver, kidney, skin diseases, or cancer
- Current anal abscess or severe eczema
- Blood clotting disorders or significant bruising
- Asplenia or splenectomy
- Immunosuppressant or cytotoxic treatment over 10 days in past 6 months
- Received blood products or immunoglobulins in past 3 months
- Received live attenuated vaccine within 14 days or any other vaccine within 7 days
- Taken antipyretic or antiallergic medicines within 3 days
- Fever ≥37.3°C before vaccination
- Participation in other clinical drug/vaccine trials
- Other investigator-determined unsuitability
- Infants 2 or 3 months who received vaccines containing meningococcal, DTP, or Hib components
- Children 18-24 months who received meningococcal or Hib vaccines within 6 months
- Abnormal blood or urine tests deemed significant before vaccination
- History of meningococcal meningitis, Hib disease, pertussis, diphtheria, or tetanus
- Serious adverse events or severe allergic reactions to prior vaccine doses
- Investigator-determined unsuitability for continued participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan, China
Actively Recruiting
Research Team
Y
Ying Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
11
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