NCT06700148已完成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 7-17 Year Olds
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 2
- 主要终点
- Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects
研究概览
简要总结
This is a randomized, blinded, 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, afterwards some subjects entered the immune persistence 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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7~17 years old at the time of screening
- •Volunteers and their legal guardians or delegates 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 180 days of study follow-up
- •Willingness to discuss medical history with the investigator or physician and to allow access to all medical records related to this trial
排除标准
- •Fever on the day of vaccination, axillary temperature >37.0°C
- •Have a moderate or severe acute illness/infection
- •Positive urine pregnancy test for females of childbearing age, or plan to become pregnant within 30 days after vaccination
- •Current meningitis or history of meningitis
- •Allergy to certain components or excipients of the drugs used in this clinical trial (mainly including: group A meningococcal podoplanoside, group C meningococcal podoplanoside, group Y meningococcal podoplanoside, group W135 meningococcal podoplanoside, sucrose, mannitol, sodium chloride, dipotassium hydrogen phosphate trihydrate, potassium dihydrogen phosphate)
- •History of epilepsy, convulsions or seizures or history or family history of psychiatric disorders
- •Previous severe allergic reactions due to drugs or vaccines
- •Bleeding constitution or condition associated with prolonged bleeding, which in the opinion of the investigator makes intramuscular injection contraindicated
- •Any meningococcal vaccine in the last 1 year
- •Any other vaccine within 14 days
- •Participation in other studies involving interventional studies within 28 days (<28 days) prior to study entry and/or during study participation
- •Other conditions that, in the judgment of the investigator, make participation in this clinical trial unsuitable
研究组 & 干预措施
ACYW135 Group Meningococcal Polysaccharide Vaccine (MPSV4)
Active Comparator
干预措施: MPSV4 (Biological)
ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197)(MCV4)
Experimental
干预措施: MCV4 (Biological)
结局指标
主要结局
Meningococcal Antibody Positive Conversion Rates and GMT for Groups A, C, Y, and W135 in All Subjects
时间窗: 30 Days After Immunization
Geometric Mean Titer (GMT) for Groups A, C, Y, and W135 in All Subjects
时间窗: 30 Days after immunization
Incidence of adverse reactions in all subjects
时间窗: Within 30 mins after immunization
Incidence of adverse reactions/events in all subjects
时间窗: Within 30 days after immunization
Incidence of adverse reactions/events in all subjects
时间窗: Within 7 days after immunization
次要结局
- Meningococcal antibody positivity for groups A, C, Y, and W135(30 days after immunization)
- Geometric mean multiplicity of increase (GMI) for groups A, C, Y, and W135(30 days after immunization)
- Antibody titer ≥1:128 ratio for groups A, C, Y, and W135(30 days after immunization)
- Meningococcal Antibody Positivity for Groups A, C, Y, and W135 in Selected Subjects(180 days after immunization)
- 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)
- 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) for all subjects(Within 180 days after immunization)
研究者
研究点 (2)
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