Clinical Trial: A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

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 Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children

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

Detailed Summary: This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

Current Primary Outcome: The incidences of adverse events (AEs) of each group [ Time Frame: 30 days ]

AEs occurred within 30 days after injection will be collected.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The incidences of abnormal results of lab tests [ Time Frame: 30 days ]
    Cases of abnormal results of laboratory tests will be collected.
  • The incidences of serious adverse events (SAEs) of each group [ Time Frame: 30 days ]
    SAEs occurred within 30 days after injection will be collected.


Original Secondary Outcome: Same as current

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

Dates:
Date Received: November 14, 2016
Date Started: April 2016
Date Completion: December 2016
Last Updated: November 19, 2016
Last Verified: November 2016