Status:

COMPLETED

Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

Lead Sponsor:

EuBiologics Co.,Ltd

Conditions:

Infection, Meningococcal

Eligibility:

All Genders

19-55 years

Phase:

PHASE1

Brief Summary

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine

Eligibility Criteria

Inclusion

  • Subjects 19 to 55 years of age
  • Written informed consent
  • Available for all visits and telephone calls scheduled for the study

Exclusion

  • Previous or suspected disease caused by N. meningitidis
  • Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
  • Serious acute, chronic or progressive disease as determined by investigator
  • History of alcohol or substance abuse

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2021

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT04714229

Start Date

September 1 2020

End Date

September 1 2021

Last Update

October 7 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul National University Hospital

Seoul, South Korea