Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
NCT ID: NCT05739292
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2023-02-28
2023-10-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EuNmCV-5
Healthy adults received 0.5mL single intramuscular dose on Day 0.
EuNmCV-5
0.5mL single intramuscular dose on Day 0
Menveo
Healthy adults received 0.5mL single intramuscular dose on Day 0.
Menveo
0.5mL single intramuscular dose on Day 0
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EuNmCV-5
0.5mL single intramuscular dose on Day 0
Menveo
0.5mL single intramuscular dose on Day 0
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent
* Available for all visits and telephone calls scheduled for the study
Exclusion Criteria
* 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
19 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EuBiologics Co.,Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
YJ Choi
Role: STUDY_DIRECTOR
EuBiologics Co.,Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EuVCT_MCV102
Identifier Type: -
Identifier Source: org_study_id