Clinical Trial: Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years

Brief Summary: The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.

Detailed Summary:
Sponsor: Changchun Changsheng Life Science and Technology Co., Ltd.

Current Primary Outcome: Immune protective effect and persistence after inoculated with live attenuated varicella vaccine [ Time Frame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine ]

Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Breakthrough rate, duration and severity of varicella in vaccinated children [ Time Frame: 5 years period ]
  • Occurrence of adverse events [ Time Frame: Up to 4 weeks after vaccination ]


Original Secondary Outcome: Same as current

Information By: Changchun Changsheng Life Science and Technology Co., Ltd.

Dates:
Date Received: October 24, 2013
Date Started: June 2013
Date Completion: December 2018
Last Updated: March 25, 2014
Last Verified: March 2014