drugset / Trial / NCT05933512

A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines

NCT05933512

Phase 2 Unknown 600 enrolled Sinocelltech Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.

Timeline

Start
2023-08-10
Primary completion
2023-12-10
Completion
2024-11-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator SCTV01E Vaccine Intramuscular
Subject SCTV01E-2 Vaccine Intramuscular

Indications