Clinical Trial: A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

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

Official Title: A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children

Brief Summary: The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Detailed Summary: This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Current Primary Outcome:

  • The incidences of varicella of each group [ Time Frame: ≥30 cases reported 30 days after injection ]
    The first 30 cases of varicella occurred 30 days after injection will be collected.
  • The protection rate of the vaccine [ Time Frame: ≥30 cases reported after 30 days of the injection ]
    The protection rate will be calculated based on the reported cases occurred 30 days after injection.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidences of adverse events (AEs) of each group [ Time Frame: 30 days ]
    AEs occurred within 30 days after injection will be collected.
  • The incidences of serious adverse events (SAEs) of each group [ Time Frame: 6 months ]
    SAEs occurred within 6 months after injection will be collected.
  • The seroconversion rate of the immunogenicity group [ Time Frame: 30 days after injection ]
    Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
  • The geometric mean titer (GMT) of the immunogenicity group [ Time Frame: 30 days ]
    Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
  • The geometric mean fold increase (GMI) of the immunogenicity group [ Time Frame: 30 days after injection ]
    Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.


Original Secondary Outcome: Same as current

Information By: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Dates:
Date Received: November 28, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: November 30, 2016
Last Verified: November 2016