Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
NCT ID: NCT07203755
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
260 participants
INTERVENTIONAL
2025-12-19
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part I, 1A, low dose, 6 year-old
One dose of DTcP-Hib-MCV4 on Day 0
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
Part I, 2A, low dose, 18~24 month-old
One dose of DTcP-Hib-MCV4 on Day 0
DTcP-Hib-MCV4
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
Part I, 2B, high dose, 18~24 month-old
One dose of DTcP-Hib-MCV4 on Day 0
DTcP-Hib-MCV4
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
Part I, 3A, low dose, 2 month-old
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
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.
Part I, 3B, high dose, 2 month-old
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
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.
Part I, 3C, 2 month-old
3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
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.
Part I, 3D, 2 month-old
3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
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.
Part I, 3E, 2 month-old
3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
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.
Part I, 4A, 3 month-old
3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
MCV4
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
Part II, Vaccine Group, 2 month-old
3 doses of MCV4 at 0, 2, and 4 months.
MCV4
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.
Part II, Placebo Group, 2 month-old
3 doses of NS at 0, 2, and 4 months.
Sodium Chloride Injection (0.9%) (Saline Solution) (NS)
3 doses of NS (0.5ml) at 0, 2, and 4 months.
Interventions
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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
DTcP-Hib-MCV4
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
DTcP-Hib-MCV4
1 dose of DTcP-Hib-MCV4 vaccine (0.5ml) on day 0
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.
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.
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.
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.
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.
MCV4
3 doses of MCV4 (0.5ml) at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
MCV4
3 doses of MCV4 (0.5ml) at 0, 2, and 4 months.
Sodium Chloride Injection (0.9%) (Saline Solution) (NS)
3 doses of NS (0.5ml) at 0, 2, and 4 months.
Eligibility Criteria
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Inclusion Criteria
* 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;
* 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 Criteria
* 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.
* 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.
* History of vaccination with any meningococcal-containing vaccine;
* 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.
2 Months
6 Years
ALL
Yes
Sponsors
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CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yanxia Wang
Role: PRINCIPAL_INVESTIGATOR
Henan Center for Disease Control and Prevention
Locations
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Liangyuan District Center for Disease Control and Prevention, Shangqiu City
Shangqiu, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Qiang Liu
Role: primary
Other Identifiers
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CTP-DHMCV-001
Identifier Type: -
Identifier Source: org_study_id