Back to resultsSafety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Primary Purpose
Infection, Meningococcal
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Infection, Meningococcal
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. meningitidis
- Household and/or intimate exposure to an individual with culture-proven N. meinigitidis 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
EuMCV4
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
1. Study Identification
Unique Protocol Identification Number
NCT04714229
Brief Title
Safety and Immunogenicity of Meningococcal Conjugate Vaccine 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 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)
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, 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
EuMCV4
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)
Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
Other Intervention Name(s)
EuMCV4
Intervention Description
0.5mL single intramuscular dose on Day 0
Intervention Type
Biological
Intervention Name(s)
Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Other Intervention Name(s)
Menveo
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. meningitidis
Household and/or intimate exposure to an individual with culture-proven N. meinigitidis 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 Lee
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 Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
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