NCT02878291

Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months

Conditions

• Meningitis, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal ACYW135 Polysaccharide Conjugate Vaccine	Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
BIOLOGICAL	Meningococcal ACYW135 Polysaccharide Conjugate Vaccine	Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2016-08-25
• Last updated: 2016-08-26

Locations

1 site across 1 country: China