NCT06226714进行中（未招募）3 期
A Randomized, Blinded, Peer-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 18-59 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 840
- 试验地点
- 3
- 主要终点
- Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects
研究概览
简要总结
This is a randomized, observer-blind, peer-controlled study. There will be 2 treatment groups, screened subjects were given study numbers in the order of enrollment and randomly assigned to the test and control groups in a 1:1 ratio. Subjects were required to complete a 1-dose immunization program with 0.5 ml of vaccine in both the test and control 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)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18~59 years old at the time of screening.
- •Should not have received any meningococcal vaccine in the last 3 years.
- •Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
- •Volunteers have given informed consent, have voluntarily signed an informed consent form, are able and willing to comply with the requirements of the clinical trial protocol, and are able to complete the 180-day study follow-up visit.
- •Willingness to discuss medical history with the investigator or physician and to allow access to all medical records relevant to this trial.
排除标准
- •Fever before vaccination, axillary temperature >37.0°C.
- •History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders.
- •Volunteers with current meningitis or a history of meningitis.
- •Blood pregnancy-positive or breastfeeding women with a planned pregnancy within 180 days of the volunteer or her partner.
- •Hypersensitivity to an ingredient or excipient of the medicinal product used in this clinical trial (mainly: group A meningococcal podophyllotoxin, group C meningococcal podophyllotoxin, group Y meningococcal podophyllotoxin, group W135 meningococcal podophyllotoxin, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate).
- •Severe hypertension uncontrolled by medication (at on-site measurement: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg).
- •Previous vaccination-related hospitalizations or emergencies.
- •Bleeding constitution or condition associated with prolonged bleeding that investigators consider contraindicated for intramuscular injection.
- •Other vaccinations within 14 days.
- •Participation in other studies involving interventional studies within 28 days prior to study entry (<28 days) and/or during study participation.
- •Other circumstances that, in the judgment of the investigator, make participation in this clinical trial inappropriate.
研究组 & 干预措施
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197) (MCV4)
Experimental
Intramuscular injection, 0.5ml
干预措施: MCV4 (Biological)
ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)
Active Comparator
Subcutaneous iniection, 0.5ml
干预措施: MPSV4 (Biological)
结局指标
主要结局
Meningococcal antibody positive conversion rates for groups A, C, Y, and W135 in all subjects
时间窗: 30 days post immunization
Geometric mean titer (GMT) of antibodies to groups A, C, Y, and W135 in all subjects
时间窗: 30 days post immunization
Incidence of adverse reactions/events in all subjects
时间窗: Within 30 days after immunization
Incidence of adverse reactions in all subjects
时间窗: Within 30 mins after immunization
次要结局
- GMT for groups A, C, Y, and W135 in selected subjects(180 days after immunization)
- GMI for groups A, C, Y, and W135 in selected subjects(180 days after immunization)
- Geometric mean multiplicity (GMI) of increase for groups A, C, Y, and W135(30 days post immunization)
- Antibody titer ≥1:128 ratio for groups A, C, Y, and W135(30 days post immunization)
- Meningococcal antibody positivity for groups A, C, Y, and W135(30 days post immunization)
- Meningococcal antibody positivity for groups A, C, Y, and W135 in selected subjects(180 days after immunization)
- Antibody titer ≥1:128 ratio for groups A, C, Y, and W135 in selected subjects(180 days after immunization)
- Incidence of serious adverse events (SAEs) in all subjects(Within 180 days after immunization)
- Incidence of pregnancy events in all subjects(Within 180 days after immunization)
研究者
研究点 (3)
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