A phase 3, observer-blind, randomized, active controlled trial to assess the safety of an investigational meningococcal serogroups ACYWX conjugate vaccine (NmCV-5) and compare its immunogenicity to a licensed meningococcal serogroups ACYW conjugate vaccine (Menactra®), in healthy subjects 2 to 29 years of age.

Serum Institute of India Pvt. Ltd.0 个研究点目标入组 1,800 人开始时间: 2019年7月4日最近更新: 2023年5月29日

研究概览

暂无简介。

•1. Male or non-pregnant female 2 through 29 years of age, inclusive, at the time of study IP administration.
•2. Written informed consent obtained from subjects at least 18 years of age or from their parent/guardian for subjects less than 18 years of age with additional subject assent obtained as appropriate for participating community (i.e. subjects at least 13 years of age in Mali or at least 12 years of age in The Gambia).
•3. Subject or parent/guardian with subject reside in study site area and are able and willing to adhere to all protocol visits and procedures.
•4. Female subjects of childbearing potential must have practiced adequate contraception for 28 days prior to study IP administration and agree to continue adequate contraception until completion of their Day 29 visit.
•5. Female subjects of childbearing potential must have a negative pregnancy test within 24 hours prior to study IP administration

•1. Acute illness, at the time of study IP administration (once acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
•2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study IP administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, subject may be re-revaluated for eligibility).
•3. Previous immunization with a Neisseria meningitidis vaccine other than MenAfriVac® during the previous five years.
•4. Current or previous, confirmed disease caused by Neisseria meningitidis.
•5. Household contact with or intimate exposure to an individual with any laboratory confirmed Neisseria meningitidis infection within 90 days prior to study IP administration.
•6. Known hypersensitivity to any component of the study IPs (i.e., NmCV-5 or Menactra®).
•7. History of significant hypersensitivity reactions to any previous vaccine.
•8. Administration of any vaccine other than study IPs within 28 days prior to study IP administration or planned administration prior to completion of the study Day 29 visit.
•9. Administration of any investigational drug within 30 days prior to study IP administration or planned administration during the study period.
•10. Unwilling to avoid (or their child to avoid, if the subject) the ingestion of herbal or other traditional medications during the study period.

发起方