Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
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
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2023
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2023
CompletedFirst Posted
Study publicly available on registry
February 22, 2023
CompletedStudy Start
First participant enrolled
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2023
CompletedDecember 20, 2023
May 1, 2023
2 months
February 12, 2023
December 19, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of solicited adverse events
local and systemic AEs
within 7 days post vaccination
Occurrence of unsolicited adverse events
within 28 days post vaccination
Occurrence of serious adverse events
within 180 days post vaccination
Study Arms (2)
EuNmCV-5
EXPERIMENTALHealthy adults received 0.5mL single intramuscular dose on Day 0.
Menveo
ACTIVE COMPARATORHealthy adults received 0.5mL single intramuscular dose on Day 0.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects 19 to 55 years of age
- Written informed consent
- Available for all visits and telephone calls scheduled for the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Related Publications (1)
Kim Y, Bae S, Yu KS, Lee S, Lee C, Kim J, Her H, Oh J. A randomized study to evaluate the safety and immunogenicity of a pentavalent meningococcal vaccine. NPJ Vaccines. 2024 Aug 7;9(1):140. doi: 10.1038/s41541-024-00935-8.
PMID: 39112515DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
YJ Choi
EuBiologics Co.,Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2023
First Posted
February 22, 2023
Study Start
February 28, 2023
Primary Completion
May 10, 2023
Study Completion
October 4, 2023
Last Updated
December 20, 2023
Record last verified: 2023-05