ClinicalTrials.gg
CompletedNCT05739292Updated Dec 20, 2023

Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old

A Phase 1 interventional study of EuNmCV-5 and Menveo in Infection, Meningococcal, sponsored by EuBiologics Co.,Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by EuBiologics Co.,Ltd · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Infection, Meningococcal
03

In context

Meningococcal Infections

243 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.

This study's enrollment of 60 is below the median of 456 across 214 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects 19 to 55 years of age
  • Written
  • Available for all visits and telephone calls scheduled for the study

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    EuNmCV-5

    Healthy adults received 0.5mL single intramuscular dose on Day 0.

    Biological: EuNmCV-5

  • Active comparator
    Menveo

    Healthy adults received 0.5mL single intramuscular dose on Day 0.

    Biological: Menveo

Interventions

  • BiologicalEuNmCV-5

    0.5mL single intramuscular dose on Day 0

    Also known as: Meningococcal(Groups A, C, W-135, X, and Y) Conjugate Vaccine

  • BiologicalMenveo

    0.5mL single intramuscular dose on Day 0

    Also known as: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine

06

What researchers measure

Primary outcomes

  1. Occurrence of solicited adverse events

    local and systemic AEs

    Time frame: within 7 days post vaccination

  2. Occurrence of unsolicited adverse events

    Time frame: within 28 days post vaccination

  3. Occurrence of serious adverse events

    Time frame: within 180 days post vaccination

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05739292
Lead sponsor
EuBiologics Co.,Ltd
Responsible party
Sponsor
First posted
Feb 22, 2023
Start date
Feb 28, 2023
Primary completion
May 10, 2023
Completion
Oct 4, 2023
Last update
Dec 20, 2023

Study contacts

YJ Choi
study director · EuBiologics Co.,Ltd

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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