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

Infection, Meningococcal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714229
• Other study ID #: EuVCT_MCV101
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2021
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine
0.5mL single intramuscular dose on Day 0
• Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
0.5mL single intramuscular dose on Day 0

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited adverse events	local and systemic AEs	within 7 days post vaccination
Primary	Occurrence of unsolicited adverse events		within 28 days post vaccination
Primary	Occurrence of serious adverse events		within 180 days post vaccination