Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 16
- 主要终点
- Primary immunogenicity parameter
研究概览
简要总结
Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
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
- Single (Participant)
盲法说明
The subject will be randomly assigned (using a computer program) to one of two groups:
The 1st group (n=40) of participants will receive the drug GNG-DE in a dose of 0.5 ml intramuscularly into the deltoid muscle area.
The 2nd group (n=40) of participants will receive Menactra® in a dose of 0.5 ml intramuscularly into the deltoid muscle area.
This study will be conducted as a single blind study, i.e. The study physician will know, but the subject will not know, which drug (study or reference drug) will be administered.
入排标准
- 年龄范围
- 3 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
- •Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and/or the parent/adoptive parent informed consent form (Parent Information Sheet, PIS) signed by one of parents/adoptive parents (for participants aged 3-17 years old inclusive).
- •Negative result of SARS-CoV-2 antigen rapid test at screening.
- •Negative pregnancy test result in fertile females of reproductive age. For females not reached puberty, and for girls/women unable to childbirth (with past infertility, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, menopause for more than 2 years), the pregnancy test shall not be performed.
- •For participants of 14-55 years old inclusive with preserved reproductive function, the consent to use of reliable methods of contraception (abstinence, condoms in combination with spermicide and/or hormonal contraception) during the study.
- •For participants aged 3-13 years old inclusive and females incapable of childbearing, the consent to use reliable methods of contraception is not required.
- •The consent of a participant and/or a parent/an adoptive parent of a participant to cooperate in good faith with the investigator and the center staff, come to appointed visits, fill out the observation diary and comply with the requirements of the Protocol.
排除标准
- •Hypersensitivity to any component of the test/reference drug.
- •Evident severe systemic reactions to any vaccines in anamnesis.
- •Impossibility of intramuscular injections.
- •Changes in the skin (pigmentation, tattoo, scars etc.) at the planned injection site of the test/reference drug (the deltoid muscle area).
- •Acute infectious and non-infectious diseases, exacerbation of chronic diseases at screening or less than 14 days before screening.
- •Body temperature measured in the armpit ≥ 37.0°C at Visits 0 and
- •The history of chronic diseases that are significant in the opinion of the investigator (for example, malignant neoplasms, blood diseases, autoimmune diseases, immunodeficiencies, etc.).
- •The history of meningococcal infection.
- •Contact with a person with the confirmed infection caused by N. meningitidis less than 2 months before screening.
- •The history of convulsive syndrome or the advanced neurological disease.
- •The history of Guillain-Barré syndrome.
- •The history of mental diseases.
- •Drug administration:
- •the history of meningococcal mono- or polyvalent vaccine, influenza vaccine within 14 days before screening, other vaccines within 30 days before screening;
- •immunostimulants less than 30 days before screening;
- •the immunosuppressive therapy, including systemic corticosteroids, prescribed for more than 5 days, or in the daily dose of more than 1 mg/kg/day of prednisolone or its equivalent - less than 30 days before screening;
- •antipyretics, analgesics - for less than 24 hours before Visits 0 and 1;
- •systemic antibacterial drugs-- for less than 72 hours before Visits 0 and 1;
- •anticoagulants - for less than 3 weeks before Visits 0 and 1;
- •immunoglobulins, blood or plasma products - for less than 3 months before Visits 0 and
- •Planning the administration of vaccines with the exception of the test/reference drug during the clinical study.
- •Surgical interventions performed less than 3 months before screening.
- •Participation in another clinical study less than 30 days before screening.
- •Other conditions that, in the opinion of the investigator, interfere to the enrollment.
研究组 & 干预措施
Stage I
At this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio
干预措施: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y (Drug)
Stage II
Stage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio
干预措施: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y (Drug)
Stage III
Stage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.
干预措施: polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y (Drug)
结局指标
主要结局
Primary immunogenicity parameter
时间窗: Day 29 ± 1
Proportion (frequency) of subjects with seroconversion to meningococcal serogroups A, C, Y and W135 Seroconversion is defined as (for each serogroup it is determined separately)
次要结局
- Secondary immunogenicity parameters(Day 29 ± 1)