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
- 11
- 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).
研究组 & 干预措施
Menactra
Subjects will be randomly assigned in a 3:1 ratio to receive either NmCV-5 or Menactra.
In Menactra arm, total 410 subjects will be enrolled.
干预措施: Menactra (Biological)
NmCV-5
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.
Total 1230 subjects will be enrolled in NmCV-5 arm.
干预措施: NmCV-5 (Biological)
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)