Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Phase 1
Completed
- Conditions
- Infection, Meningococcal
- Interventions
- Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate VaccineBiological: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
- Registration Number
- NCT04714229
- Lead Sponsor
- EuBiologics Co.,Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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. 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EuMCV4 Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine Healthy adults received 0.5mL single intramuscular dose on Day 0. Menveo Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine Healthy adults received 0.5mL single intramuscular dose on Day 0.
- Primary Outcome Measures
Name Time Method Occurrence of unsolicited adverse events within 28 days post vaccination Occurrence of serious adverse events within 180 days post vaccination Occurrence of solicited adverse events within 7 days post vaccination local and systemic AEs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of