NCT04714229

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 7, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 14, 2021

Last Update Submit

October 6, 2021

Conditions

Infection, Meningococcal

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

EuMCV4

EXPERIMENTAL

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

Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine

Menveo

ACTIVE COMPARATOR

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

Biological: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine

Interventions

Meningococcal(Groups A, C, W-135, and Y) Conjugate VaccineBIOLOGICAL

0.5mL single intramuscular dose on Day 0

Also known as: EuMCV4
EuMCV4
Meningococcal(Groups A, C, Y, and W-135) Conjugate VaccineBIOLOGICAL

0.5mL single intramuscular dose on Day 0

Also known as: Menveo
Menveo

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Vaccines, ConjugateMeningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Vaccines, SyntheticVaccinesBiological ProductsComplex MixturesAntigensBiological FactorsBacterial Vaccines

Study Officials

  • YJ Lee

    EuBiologics Co.,Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 19, 2021

Study Start

September 1, 2020

Primary Completion

November 1, 2020

Study Completion

September 1, 2021

Last Updated

October 7, 2021

Record last verified: 2021-01

Locations

KR(1)