drugset / Trial / NCT05050474

Booster Immunization Study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

NCT05050474 ↗

NaSingle-groupOpen-labelPrevention

Summary

This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01. The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01. The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

Timeline

Start
2021-08-07
Primary completion
2022-02-18
Completion
2022-02-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant SARS-CoV-2 Fusion Protein Vaccine Vaccine 10 ug Intramuscular

Indications