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Correlation of Protection Against Varicella in an Exploratory Study
Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Summary
This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.
Key Details
Gender
All
Age Range
1 Year - 12 Years
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2025-10-10
Completion Date
2028-10-10
Last Updated
2025-01-27
Healthy Volunteers
Yes
Conditions
Interventions
Varicella vaccine
lyophilized powder,subcutaneous injection