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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05739292

Enrollment

Registered

2023-02-22

Start date

2023-02-28

Completion date

2023-10-04

Last updated

2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Meningococcal

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

Interventions

BIOLOGICALEuNmCV-5

0.5mL single intramuscular dose on Day 0

BIOLOGICALMenveo

0.5mL single intramuscular dose on Day 0

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026