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

Primary Purpose

Infection, Meningococcal

Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EuNmCV-5
Menveo
Sponsored by
EuBiologics Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection, Meningococcal

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EuNmCV-5

Menveo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Occurrence of solicited adverse events
local and systemic AEs
Occurrence of unsolicited adverse events
Occurrence of serious adverse events

Secondary Outcome Measures

Full Information

First Posted
February 12, 2023
Last Updated
May 10, 2023
Sponsor
EuBiologics Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05739292
Brief Title
Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuBiologics Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Meningococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EuNmCV-5
Arm Type
Experimental
Arm Description
Healthy adults received 0.5mL single intramuscular dose on Day 0.
Arm Title
Menveo
Arm Type
Active Comparator
Arm Description
Healthy adults received 0.5mL single intramuscular dose on Day 0.
Intervention Type
Biological
Intervention Name(s)
EuNmCV-5
Other Intervention Name(s)
Meningococcal(Groups A, C, W-135, X, and Y) Conjugate Vaccine
Intervention Description
0.5mL single intramuscular dose on Day 0
Intervention Type
Biological
Intervention Name(s)
Menveo
Other Intervention Name(s)
Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Intervention Description
0.5mL single intramuscular dose on Day 0
Primary Outcome Measure Information:
Title
Occurrence of solicited adverse events
Description
local and systemic AEs
Time Frame
within 7 days post vaccination
Title
Occurrence of unsolicited adverse events
Time Frame
within 28 days post vaccination
Title
Occurrence of serious adverse events
Time Frame
within 180 days post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YJ Choi
Organizational Affiliation
EuBiologics Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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