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

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

Study Overview

• Status: Completed
• Conditions: Infection, Meningococcal
• Intervention / Treatment: Biological: Menveo; Biological: EuNmCV-5

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Menveo; Healthy adults received 0.5mL single intramuscular dose on Day 0.	Biological: Menveo; 0.5mL single intramuscular dose on Day 0; Other Names: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Experimental: EuNmCV-5; Healthy adults received 0.5mL single intramuscular dose on Day 0.	Biological: EuNmCV-5; 0.5mL single intramuscular dose on Day 0; Other Names: Meningococcal(Groups A, C, W-135, X, and Y) Conjugate Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EuBiologics Co.,Ltd
• Investigators: Study Director: YJ Choi, EuBiologics Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Actual): May 10, 2023
• Study Completion (Actual): October 4, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: EuVCT_MCV102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No