A Randomized, Double-Blind, Active Comparator-Controlled Phase Ⅲ Trial to Evaluate the Immunogenicity and Safety of the Group ACYW135 Meningococcal Conjugate Vaccine in Population Aged 12 to 23 Months
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,040
- 试验地点
- 2
- 主要终点
- seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
研究概览
简要总结
The goal of this clinical trial is to evaluate the immunogenicity and safety of an investigational group ACYW135 Meningococcal conjugate vaccine in healthy children aged 12 to 23 months.
The main questions it aims to answer are:
Is the immune response induced by the investigational vaccine non-inferior to that of the licensed control vaccine? What safety profile does the investigational vaccine have in this pediatric population? Researchers will compare the investigational vaccine group with the active comparator group (licensed ACYW135 meningococcal conjugate vaccine (CRM197 carrier), CanSinoBIO; hereinafter referred to as CanSinoBIO MCV-ACYW) to determine if the new vaccine provides comparable immune protection with an acceptable safety profile.
Participants will:
Receive two doses of either the investigational vaccine or the control vaccine according to a 0,1-month schedule; Be observed for 30 minutes after each dose for immediate adverse reactions; Have solicited local and systemic adverse events recorded for 7 days after each dose using diary cards; Have unsolicited adverse events recorded for 30 days after each dose using diary cards; Be monitored for serious adverse events for at least 6 months after completion of the primary immunization series; A total of 1040 participants will be enrolled and randomly assigned in a 1:1 ratio to either the investigational group or the control group.
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)
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants aged 12 to 23 months.
- •The participant's legal guardian is capable of understanding and voluntarily signs the informed consent form.
- •Willing and able to comply with all scheduled visits, sample collection, vaccination, and other trial procedures.
- •Provision of legal identification documentation.
排除标准
- •History (or suspected history) of meningococcal disease.
- •History of infantile wheezing; history of allergy to the vaccine or any vaccine components (Group A/C/Y/W135 meningococcal capsular polysaccharide, mannitol, sucrose, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, water for injection), such as urticaria, dyspnea, angioedema; or other serious adverse reactions following prior vaccination.
- •Prior vaccination with Group A meningococcal polysaccharide vaccine with an interval ≤6 months since the most recent dose; prior vaccination with any other meningococcal vaccine other than Group A meningococcal polysaccharide vaccine (including but not limited to: Group A/C meningococcal polysaccharide/conjugate vaccine, ACYW135 meningococcal polysaccharide/conjugate vaccine).
- •Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection in the participant or the participant's mother).
- •Coagulation disorders (e.g., coagulation factor deficiency, platelet abnormalities) or history of significant bleeding, hematoma, or ecchymosis following intramuscular injection or venipuncture.
- •Presence of poorly controlled chronic diseases or history of serious illnesses, including but not limited to cardiovascular diseases, metabolic diseases, hematological diseases, hepatorenal diseases, gastrointestinal diseases, respiratory diseases, malignancies, or history of major organ transplantation.
- •Severe congenital anomalies, genetic defects, or malnutrition.
- •Presence of or history of severe neurological disorders [epilepsy, convulsions or seizures], or family history of psychiatric disorders.
- •Receipt of immunoglobulins or other blood products within the past 3 months, or planned receipt of such treatments during the study period.
- •Receipt of immunosuppressants or other immunomodulatory therapy for ≥14 days (e.g., prednisone ≥20 mg/day or ≥2 mg/kg/day, or equivalent), cytotoxic therapy within the past 6 months, or planned receipt of such therapies during the study period.
- •Receipt of any other investigational drug or vaccine within the past 3 months, or planned receipt during the study period.
- •Receipt of a live attenuated vaccine within the past 14 days, or receipt of a subunit or inactivated vaccine within the past 7 days.
- •Receipt of any other licensed vaccine within the past 28 days where administration at a different injection site from the study vaccine cannot be ensured.
- •Acute illness or acute exacerbation of chronic disease within the past 3 days, or known or suspected active infection.
- •Fever (axillary temperature >37.0°C) on the day of scheduled study vaccination, or abnormal findings on physical examination that preclude vaccination.
- •Skin lesions, inflammation, ulcers, rash, or scarring at the intended injection site that may interfere with vaccination or local reaction assessment.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical trial.
研究组 & 干预措施
experimental group
干预措施: experimental vaccine (Biological)
active comparator group
干预措施: Active Comparator vaccine (Biological)
结局指标
主要结局
seroconversion rates (%) of Nm antibodies for serogroups A, C, Y, W135
时间窗: Day 30 after two-dose vaccination
seroconversion rates of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135
时间窗: Day 30 after two-dose vaccination
GMTs of Nm antibodies for serogroups A, C, Y, W135 at Day 30 after two-dose vaccination in baseline seronegative participants (pre-vaccination titer \<1:8)
次要结局
- seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135(Day 30 after two-dose vaccination)
- GMIs (1:) of Nm antibodies for serogroups A, C, Y, W135(Day 30 after two-dose vaccination)
- seroconversion rates (%) and seropositive rates (%) of Nm antibodies for serogroups A, C, Y, W135(Day 30 after two-dose vaccination)
- GMTs (1:) of Nm antibodies for serogroups A, C, Y, W135(Day 30 after two-dose vaccination)
- GMIs of Nm antibodies for serogroups A, C, Y, W135(Day 30 after two-dose vaccination)
- proportions of participants with Nm antibody titers ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for serogroups A, C, Y, and W135(Day 30 after two-dose vaccination)
- incidence of adverse reactions/events(within 30 minutes after each dose vaccination)
- incidence of adverse reactions/events(within 0~30 days after each dose vaccination)
- incidence of serious adverse events(from the first dose to six months after the second dose)