A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
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|ClinicalTrials.gov Identifier: NCT02965404|
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Varicella||Biological: Investigational live attenuated varicella vaccine Biological: control live attenuated varicella vaccine Biological: diluent of lyophilized vaccine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Experimental Group
Biological: Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Active Comparator: Positive Control Group
Biological: control live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
Sham Comparator: Negative Control Group
Biological: diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965404
|Xiangcheng County Center for Disease Control and Prevention|
|Xuchang, Henan, China, 461700|
|Principal Investigator:||Shengli Xia||Henan Provincial Center for Disease Control and Prevention|