NCT04714229

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: EuBiologics Co.,Ltd · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Infection, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine	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

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-11-01
• Completion: 2021-09-01
• First posted: 2021-01-19
• Last updated: 2021-10-07

Locations

1 site across 1 country: South Korea