Status:
RECRUITING
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Lead Sponsor:
CanSino Biologics Inc.
Conditions:
Diphtheria, Tetanus and Acellular Pertussis
Epidemic Meningitis
Eligibility:
All Genders
2-6 years
Phase:
PHASE1
Brief 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-c...
Eligibility Criteria
Inclusion
- General
- Participants aged 2 months (60-89 days), 3 months (90-119 days), 18-24 months, and 6 years of age, with legal guardians or authorized representatives willing to provide identification documentation;
- Legal guardians or authorized representatives provide informed consent, voluntarily sign the informed consent form, and are able to comply with the requirements of the clinical trial protocol;
- Part I: Specific
- Individuals aged 18-24 months who have completed a 3-dose DTaP-containing vaccine series and a meningococcal-containing vaccine primary series, but have not received a DTaP-containing booster dose;
- Individuals aged 6 years who have completed 4 doses of DTaP-containing vaccine but have not received the 5th DTaP-containing vaccine dose; and have only completed the first meningococcal-containing vaccine booster dose, without receiving the second meningococcal-containing vaccine booster dose at age 6.
Exclusion
- General Exclusion Criteria for First Dose：
- Infants born prematurely (delivery before 37 weeks gestation) or with low birth weight (\<2500g) at 2 months (60-89 days) or 3 months (90-119 days) of age;
- Infants aged 2 months (60-89 days) or 3 months (90-119 days) with history of abnormal labor, asphyxia requiring resuscitation, or neurological impairment;
- Severe congenital malformations or developmental disorders, genetic defects, or severe malnutrition;
- History of severe adverse reactions or anaphylaxis to vaccines or vaccine components, such as urticaria, dyspnea, angioedema;
- History of epilepsy, convulsions, seizures, cerebral palsy, psychiatric disorders, or family history thereof; or history of progressive neurological diseases (e.g., Guillain-Barré syndrome, brachial plexus neuritis);
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), juvenile rheumatoid arthritis (JRA), or other autoimmune diseases;
- Acute illness (e.g., fever ≥38.5°C, diarrhea) or acute exacerbation of chronic disease within 3 days prior to receiving the investigational product;
- Known or suspected severe chronic diseases (including: severe respiratory disease, severe cardiovascular disease, liver/kidney disease, severe dermatology conditions, malignancies, etc.);
- Current anal abscess or severe eczema;
- Clinically diagnosed coagulation disorders (e.g., factor deficiency, bleeding disorders, platelet abnormalities) or significant bruising/coagulation impairment;
- Asplenia, functional asplenia, or splenectomy due to any cause;
- Continuous treatment with immunosuppressants, immunomodulators, or cytotoxic agents (exceeding 10 days) within the past 6 months; inhaled or topical steroids are permitted;
- Receipt of blood products or immunoglobulins (excluding hepatitis B immunoglobulin) within the past 3 months;
- Received an injectable live attenuated vaccine within 14 days, or any other vaccine within 7 days;
- Taken antipyretic analgesics or antiallergic medications within 3 days;
- Fever present prior to vaccination, with axillary temperature ≥37.3°C (99.3°F);
- Plans to participate in or is currently participating in any other drug/vaccine clinical trial;
- Any other factors deemed by the investigator to make the subject unsuitable for participation in the clinical trial.
- Part I: Exclusion Criteria for the First Dose：
- Infants aged 2 months (60-89 days) who have received vaccines containing meningococcal, DTP, or Haemophilus influenzae type b components;
- Infants aged 3 months (90-119 days) who have received a vaccine containing meningococcal components;
- Individuals aged 18-24 months who have received vaccines containing meningococcal or Haemophilus influenzae type b components within the past six months;
- Individuals aged 18-24 months with abnormal pre-vaccination blood count or urinalysis results deemed clinically significant by the investigator;
- Children aged 6 years who, prior to vaccination, exhibit abnormal results in relevant indicators of complete blood count, blood biochemistry, coagulation function, or urinalysis, and are deemed clinically significant by the investigator;
- Individuals with a history of any of the following diseases: meningococcal meningitis, Haemophilus influenzae type b disease, pertussis, diphtheria, or tetanus.
- Part II: Specific Exclusion Criteria for the First Dose
- History of vaccination with any meningococcal-containing vaccine;
- History of meningococcal disease. General Exclusion Criteria for Subsequent Doses：
- Occurrence of a serious adverse event related to vaccination following the previous dose;
- Vaccine-related Grade 3 or higher allergic reaction following the previous dose;
- Any other factors deemed by the investigator to make the subject unsuitable for continued participation in the clinical trial.
Key Trial Info
Start Date :
December 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT07203755
Start Date
December 19 2025
End Date
February 1 2029
Last Update
December 31 2025
Active Locations (1)
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1
Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan, China