NCT05739292
Completed
Phase 1
A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135, X and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
ConditionsInfection, Meningococcal
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Infection, Meningococcal
- Sponsor
- EuBiologics Co.,Ltd
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Occurrence of solicited adverse events
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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, X, and Y)-CRM197 Conjugate vaccine
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects 19 to 55 years of age
- •Written informed consent
- •Available for all visits and telephone calls scheduled for the study
Exclusion Criteria
- •Previous or suspected disease caused by N. meningitides
- •Household and/or intimate exposure to an individual with culture-proven N. meningitides infection within 60 days prior to screening
- •Serious acute, chronic or progressive disease as determined by investigator
- •History of alcohol or substance abuse
Outcomes
Primary Outcomes
Occurrence of solicited adverse events
Time Frame: within 7 days post vaccination
local and systemic AEs
Occurrence of unsolicited adverse events
Time Frame: within 28 days post vaccination
Occurrence of serious adverse events
Time Frame: within 180 days post vaccination
Study Sites (1)
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