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
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,640
- 试验地点
- 11
- 主要终点
- 1. To demonstrate the consistency of immune response from three lots of NmCV-5
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 adult Indian subjects 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). All subjects will receive single dose of either NmCV-5 or Menactra as 0.5 ml IM injection and be followed for 6 months post vaccination. The immune response will be measured in the sera samples collected at Day 0 (pre vaccination) and 28 days post vaccination. Safety will be assessed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or non-pregnant female 18 through 85 years of age, 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 defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment of the investigator.
- •Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 29 visit.
排除标准
- •Acute illness, at the time of study vaccine administration (temporary criterion).
- •Recorded fever within 3 days prior to study vaccine administration.
- •History of any meningococcal vaccine administration.
- •Disease caused by N.
- •meningitidis.
- •meningitidis infection within 90 days prior 6.H/O severe allergic reactions 7.Impaired/altered function of immune system 8.Contraindication to intramuscular injection or blood draw.
- •9.Chronic administration of immunosuppressant.
- •10.Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin in the past 3 months.
- •11.Administration of any vaccine within 28 days prior to enrolment or planned during study 12.Pregnant or breast-feeding.
- •13.Systemic antibiotic within 3 days prior.
结局指标
主要结局
1. To demonstrate the consistency of immune response from three lots of NmCV-5
时间窗: 28 days post vaccination
次要结局
- Safety:(To assess the safety and tolerability of study vaccines.)