NCT05239975

A Study of the Immunogenicity and Safety of SCTV01C in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine

A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) in Population Aged ≥12 Years and Previously Vaccinated With Inactivated COVID-19 Vaccine

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.

Detailed description

This is a randomized, double-blind, approved vaccine-controlled Phase II booster study to evaluate the immunogenicity and safety of SCTV01C compared with Comirnaty in participants aged ≥12 years and previously fully immunized with inactivated COVID-19 vaccine.

Conditions

• COVID-19
• SARS-CoV2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01C	intramuscular injection
BIOLOGICAL	Comirnaty	intramuscular injection

Timeline

• Start date: 2022-04-25
• Primary completion: 2022-07-01
• Completion: 2023-02-01
• First posted: 2022-02-15
• Last updated: 2024-02-09