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 MenactraÂ® in Healthy Individuals 18-85 Years of Age

Serum Institute of India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or non-pregnant female 18 through 85 years of age, inclusive, at the time of study vaccine administration.
•2. Provide written informed consent.
•3. 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
•4. 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.
•5. 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.

•1. Acute illness, at the time of study vaccine administration (temporary criterion).
•2. Recorded fever within 3 days prior to study vaccine administration.
•3. History of any meningococcal vaccine administration.
•4. Disease caused by N. meningitidis.
•5. Household contact with and/or intimate exposure to N. 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.

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