Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
Phase 1
Completed
- Conditions
- Infection, Meningococcal
- Interventions
- Biological: MenveoBiological: EuNmCV-5
- Registration Number
- NCT05739292
- 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, X, 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. 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Menveo Menveo Healthy adults received 0.5mL single intramuscular dose on Day 0. EuNmCV-5 EuNmCV-5 Healthy adults received 0.5mL single intramuscular dose on Day 0.
- Primary Outcome Measures
Name Time Method Occurrence of solicited adverse events within 7 days post vaccination local and systemic AEs
Occurrence of unsolicited adverse events within 28 days post vaccination Occurrence of serious adverse events within 180 days post vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of