Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07834073
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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