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

EuBiologics Co.,Ltd60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Infection, Meningococcal

Interventions

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

0.5mL single intramuscular dose on Day 0

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

0.5mL single intramuscular dose on Day 0

Eligibility

Sex: ALLMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Occurrence of solicited adverse events

local and systemic AEs

Time frame: within 7 days post vaccination

Occurrence of unsolicited adverse events

Time frame: within 28 days post vaccination

Occurrence of serious adverse events

Time frame: within 180 days post vaccination

Data from ClinicalTrials.gov

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