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Immunogenicity and Safety of a Single Dose of mRNA SARS-CoV-2 Vaccine in Chinese Adults With Hybrid Immunity
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Summary
This is a multicentre post-marketing cohort study to evaluate the immunogenicity and safety of a single dose of mRNA SARS-CoV-2 vaccine SYS6006 in Chinese adults predominantly with hybrid immunity. A total of 2,052 adults aged 18 years and older who received one dose of SYS6006 were monitored for serious adverse events (SAEs) for 6 months. The first 60 participants comprised an immunogenicity subgroup, with blood samples collected before vaccination and at day 14, month 3, and month 6 post-vaccination to assess humoral and cellular immune responses.
Official title: Immunogenicity and Safety of a Single Dose of mRNA COVID-19 Vaccine in Chinese Adults With Hybrid Immunity: a Multicentre, Open-label, Single-arm, Post-marketing Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2052
Start Date
2023-05-23
Completion Date
2024-02-28
Last Updated
2026-09-22
Healthy Volunteers
Yes
Conditions
Interventions
SYS6006
Lipid nanoparticle (LNP)-encapsulated mRNA SARS-CoV-2 vaccine, 30 μg mRNA/0.3 mL, single intramuscular dose.
Locations (1)
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, China