NCT05238441

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine

A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (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 SCTV01E in participants aged ≥18 years and previously fully immunized with mRNA COVID-19 vaccine.

Detailed description

The study is a randomized, double-blind, and positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E as booster compared with Comirnaty. The study is a randomized, double-blind, and positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E as booster compared with Comirnaty (the COVID-19 vaccine from Pfizer-BioNTech).

Conditions

• COVID-19
• Sars-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01E	D0; intramuscular injection
BIOLOGICAL	Comirnaty	D0; intramuscular injection
BIOLOGICAL	SCTV01E	D180; intramuscular injection
BIOLOGICAL	Comirnaty	D180; intramuscular injection

Timeline

• Start date: 2022-03-20
• Primary completion: 2022-06-01
• Completion: 2023-05-01
• First posted: 2022-02-14
• Last updated: 2022-03-02