NCT05238454

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C in Population Aged ≥18 Years and Previously Fully Vaccinated With COVID-19 Vaccine

A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.

Detailed description

The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01C	intramuscular injection
BIOLOGICAL	Sinopharm inactivated COVID-19 vaccine	intramuscular injection
BIOLOGICAL	Comirnaty	intramuscular injection

Timeline

• Start date: 2022-03-20
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2022-02-14
• Last updated: 2022-03-02