Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old

October 6, 2021 updated by: EuBiologics Co.,Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EuMCV4
Healthy adults received 0.5mL single intramuscular dose on Day 0.
Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
0.5mL single intramuscular dose on Day 0
Other Names:
  • EuMCV4
ACTIVE_COMPARATOR: Menveo
Healthy adults received 0.5mL single intramuscular dose on Day 0.
Biological: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
0.5mL single intramuscular dose on Day 0
Other Names:
  • Menveo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of solicited adverse events
Time Frame: within 7 days post vaccination
local and systemic AEs
within 7 days post vaccination
Occurrence of unsolicited adverse events
Time Frame: within 28 days post vaccination
within 28 days post vaccination
Occurrence of serious adverse events
Time Frame: within 180 days post vaccination
within 180 days post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuBiologics Co.,Ltd

Investigators

  • Study Director: YJ Lee, EuBiologics Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

November 1, 2020

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (ACTUAL)

January 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EuVCT_MCV101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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