A Phase 2/3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistency of SIIPL Meningococcal ACYWX Conjugate Vaccine (NmCV-5) and to Compare Its Safety and Immunogenicity With That of Licensed Meningococcal ACWY Vaccine Menactra® in Healthy Individuals 18-85 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,640
- 试验地点
- 22
- 主要终点
- Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
研究概览
简要总结
This is a Phase 2/3, randomized, observer blind, multi-centre, controlled study to evaluate the safety, immune response and consistency of immune response of three consecutively manufactured lots of NmCV-5 in healthy individuals between the ages of 18 to 85 years (both inclusive). The immune response of NmCV-5 will also be statistically compared against a licensed conjugate vaccine against ACYW (Menactra).
A total of 1640 subjects 18 to 85 years of age will be accrued contemporaneously across three age groups - 18 to 29 years, 30 to 60 years, and 61 to 85 years. Within each age group subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra. The NmCV-5 subjects in 18-29 year age group will be further randomized 1:1:1 into three different lots (Lot A, B & C) of NmCV-5.
All the randomized subjects will receive a single dose of 0.5 ml of NmCV-5 or Menactra on Day 1. Post vaccination site visits are planned on Days 8, 29 and 180 and a telephonic call at Day 85.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female 18 through 85 years of age, both inclusive, at the time of study vaccine administration.
- •Provide written informed consent.
- •The subject is resident of the study area and is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
- •Healthy, as determined by medical history and clinical assessment of the investigator.
- •Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.
排除标准
- •Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject will be re-revaluated for eligibility).
- •History of any meningococcal vaccine administration.
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 90 days prior to vaccination.
- •History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
结局指标
主要结局
Percentage of subjects with seroresponse 28 days after vaccination in pooled NmCV-5 and Menactra vaccine groups
时间窗: 28 days after immunization
rSBA assay Geometric Mean Titers (GMTs) at Day 29 against serogroups A, C, W, Y and X in subjects 18 to 29 years of age.
时间窗: 1 month after vaccination
次要结局
- rSBA GMTs at Days 1 and 29 against serogroups A, C, W, Y and X in pooled NmCV-5# and Menactra vaccine groups.(Days 1 and 29)