A Phase 3, Randomized, Double-blind, Controlled, Multi-Center Study to Compare Immunogenicity and Safety of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) with that of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Indian Children of 9 months to 17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 810
- 试验地点
- 6
- 主要终点
- Percentage of participants with seroresponse against each meningococcal serogroup A, C, W, Y and X.
研究概览
简要总结
Neisseria meningitidis is a bacteria responsible for invasive meningococcal disease (IMD), that includes most commonly meningitis and fulminant septicaemia. Pneumonia, myocarditis, or pericarditis may also occur in IMD, though less commonly.
Neisseria meningitidis are classified into serogroups based on their capsular polysaccharides. Six of these serogroups viz. A, B, C, W, X, and Y are known to cause majority of IMD cases.
To tackle this problem, Serum Institute of India Pvt Ltd has developed meningococcal vaccine NmCV-5 (MenFive) which is a pentavalent conjugate vaccine composed of serogroups A, C, Y, W, and X of Neisseria meningitidis.
NmCV-5 is approved for active immunization of individuals aged 18-85 years against invasive meningococcal disease caused by Neisseria Meningitidis serogroups A, C, Y, W, and X in India. WHO has approved NmCV-5 for use in individuals aged 9 months to 85 years.
A current Phase 3 study is planned in healthy Indian children aged 9 months to 17 years to demonstrate effective immune responses and safety of NmCV-5 in comparison with the licensed quadrivalent meningococcal conjugate vaccine (MenACWY-D).
This study will help to extend the marketing authorization of NmCV-5 for this age group in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 9.00 Month(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Parent written informed consent.
- •2.Participants assent (verbal assent for 7 to 11 years old children and written assent for 12 to 17 years old children) 3.Female participants of 12 to 17 years of age who have attained menarche must have a negative urine pregnancy test 4.Healthy, as determined by medical history and clinical assessment of the investigator.
排除标准
- •1.Acute illness 2.H/O meningococcal vaccine administration.
- •3.History of severe allergic reactions after previous vaccinations or hypersensitivity to tetanus, diphtheria and diphtheria toxoid (CRM197).
- •4.Any confirmed or suspected condition with impaired/altered function of immune system 5.Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination 6.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
- •7.Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines 8.Acute or chronic, clinically significant systemic disorder/disease.
- •9.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study.
结局指标
主要结局
Percentage of participants with seroresponse against each meningococcal serogroup A, C, W, Y and X.
时间窗: Cohort 1: Children 9 to 23 months: at Day 29 in NmCV-5 group and at Day 112 in Menactra group. | Cohort 2, Children 2 to 17 years of age: at Day 29
次要结局
- rSBA Geometric mean titers (GMT)(Cohort 1: at Days 1, 29 and 112)
- rSBA titers ≥ 1:8(Cohort 1: at Days 1, 29 and 112)
- rSBA titers ≥ 1:128(Cohort 1: at Days 1, 29 and 112)