drugset / Trial / NCT07834073

Immunogenicity and Safety of a Single Dose of mRNA SARS-CoV-2 Vaccine in Chinese Adults With Hybrid Immunity

NCT07834073 ↗

NaSingle-groupOpen-labelPrevention

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.

Timeline

Start
2023-05-23
Primary completion
2024-02-28
Completion
2024-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject SYS6006 Messenger RNA (mRNA) 30 ug Intramuscular

Indications