NCT07203755招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Incidence of adverse reactions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Part One: Partial Blind Method Design Part Two: Blind Method Design
入排标准
- 年龄范围
- 2 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Part I, 1A, low dose, 6 year-old
Experimental
One dose of DTcP-Hib-MCV4 on Day 0
干预措施: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis-Haemophilus influenzae type b (Conjugate)-Meningococcal Group ACYW135 (Conjugate) Combined Vaccine (DTcP-Hib-MCV4) (Biological)
Part I, 2A, low dose, 18~24 month-old
Experimental
One dose of DTcP-Hib-MCV4 on Day 0
干预措施: DTcP-Hib-MCV4 (Biological)
Part I, 2B, high dose, 18~24 month-old
Experimental
One dose of DTcP-Hib-MCV4 on Day 0
干预措施: DTcP-Hib-MCV4 (Biological)
Part I, 3A, low dose, 2 month-old
Experimental
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
干预措施: DTcP-Hib-MCV4 (Biological)
Part I, 3B, high dose, 2 month-old
Experimental
3 doses of DTcP-Hib-MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
干预措施: DTcP-Hib-MCV4 (Biological)
Part I, 3C, 2 month-old
Active Comparator
3 doses of DTcP at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
干预措施: Adsorbed Acellular Pertussis (3-Component) Diphtheria-Tetanus-Pertussis (DTcP) (Biological)
Part I, 3D, 2 month-old
Active Comparator
3 doses of Hib at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
干预措施: Haemophilus influenzae type b (Conjugate) (Hib) (Biological)
Part I, 3E, 2 month-old
Active Comparator
3 doses of MCV4 at 0, 2, and 4 months, followed by a booster dose at 18-24 months of age.
干预措施: Meningococcal Group ACYW135 (Conjugate) (MCV4) (Biological)
Part I, 4A, 3 month-old
Active Comparator
3 doses of MCV4 at 0, 1, and 2 months, followed by a booster dose at 12 months of age.
干预措施: MCV4 (Biological)
Part II, Vaccine Group, 2 month-old
Experimental
3 doses of MCV4 at 0, 2, and 4 months.
干预措施: MCV4 (Biological)
Part II, Placebo Group, 2 month-old
Placebo Comparator
3 doses of NS at 0, 2, and 4 months.
干预措施: Sodium Chloride Injection (0.9%) (Saline Solution) (NS) (Other)
结局指标
主要结局
Incidence of adverse reactions
时间窗: Parts I and II: Within 14 days after each dose
次要结局
- 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)
研究者
研究点 (1)
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