Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Not Applicable
Not yet recruiting
- Conditions
- Diphtheria, Tetanus and Acellular PertussisEpidemic MeningitisHaemophilus Influenzae Type B Infection
- Interventions
- Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4)Biological: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP)Biological: Haemophilus influenzae type b (Conjugate) (Hib)Biological: Meningococcal Group ACYW135 (Conjugate) (MCV4)Other: Sodium Chloride Injection (0.9%) (Saline Solution) (NS)
- Registration Number
- NCT07203755
- Lead Sponsor
- CanSino Biologics Inc.
- 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-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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 260
Inclusion Criteria
General Inclusion Criteria:
- 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 Inclusion Criteria:
- 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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part I, 1A, low dose, 6 year-old Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) One dose of DTcP-Hib-MCV4 on Day 0 Part I, 2A, low dose, 18~24 month-old DTcP-Hib-MCV4 One dose of DTcP-Hib-MCV4 on Day 0 Part I, 2B, high dose, 18~24 month-old DTcP-Hib-MCV4 One dose of DTcP-Hib-MCV4 on Day 0 Part I, 3A, low dose, 2 month-old DTcP-Hib-MCV4 3 doses of DTcP-Hib-MCV4 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 DTcP-Hib-MCV4 3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Part I, 3C, 2 month-old Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) 3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Part I, 3D, 2 month-old Haemophilus influenzae type b (Conjugate) (Hib) 3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Part I, 3E, 2 month-old Meningococcal Group ACYW135 (Conjugate) (MCV4) 3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age. Part I, 4A, 3 month-old MCV4 3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age. Part II, Vaccine Group, 2 month-old MCV4 3 doses of MCV4 at 0, 2, and 4 months. Part II, Placebo Group, 2 month-old Sodium Chloride Injection (0.9%) (Saline Solution) (NS) 3 doses of NS at 0, 2, and 4 months.
- Primary Outcome Measures
Name Time Method Incidence of adverse reactions Parts I and II: Within 14 days after each dose
- Secondary Outcome Measures
Name Time Method Incidence of adverse events Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 14 days after each dose Incidence of adverse reactions/events Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 30 days after each dose Incidence of Serious Adverse Event (SAE) Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose Incidence of Adverse Event of Special Interest (AESI) Part I Sections 3A, 3B, 3C, 3D, 3E, 4A and Part II: Within 180 days after the first dose to the booster dose Abnormal laboratory test values Part I Sections 1A, 2A, 2B: 4 days after exemption Seroconversion Rate of A, C, Y, W135 Group Meningococcal Antibody Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination Geometric Mean Titer (GMT) of A, C, Y, W135 Group Meningococcal Antibody Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Positive Rate of A, C, Y, W135 Group Meningococcal Antibody Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Geometric mean increase (GMI) of A, C, Y, W135 Group Meningococcal Antibody Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Proportion of individuals with ≥1:128 titers for A, C, Y, W135 Group Meningococcal Antibody Part I Sections 3A, 3B, 3C, 3D, 3E, 4A: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Seroconversion rates of serum anti-Pertussis Toxoid (PT), Filamentous hemagglutmin (FHA), Pertactin (PRN), Diphtheria Toxoid (DT), Tetanus Toxoid (TT) antibody Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Geometric Mean Concentration (GMC) of serum anti-PT, FHA, PRN, DT, TT antibody Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Seropositivity rate of serum anti-PT, FHA, PRN, DT, TT antibody Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 GMI of serum anti-PT, FHA, PRN, DT, TT antibody Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Percentage of serum anti-Hib-Polyribosyl Ribitol Phosphate (PRP) antibody concentrations ≥0.15 μg/ml Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Percentage of serum anti-Hib-PRP antibody concentrations ≥1.0 μg/ml Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 GMC of serum anti-Hib-PRP antibodies Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 Seroconversion rate of serum anti-Hib-PRP antibodies Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3 GMI of serum anti-Hib-PRP antibodies Part I Sections 3A, 3B, 3C, 3D, 3E: 30 days after primary vaccination, 30 days before and after booster vaccination, at the age 3