NCT05345873

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine as a Booster Dose in Population Aged 12-17 Years

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 Adolescents Aged 12-17 Years and Previously Fully Vaccinated With mRNA COVID-19 Vaccine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Sinocelltech Ltd. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with mRNA-1273 (the mRNA COVID-19 vaccine from Moderna) in population aged 12-17 years old and previously vaccinated with 2 doses of mRNA COVID-19 vaccine.

Detailed description

Approximately 300 participants aged 12-17 years old and previously vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna, participants previously vaccinated with mRNA1273 are more preferred) will be enrolled in this study and be randomly assigned to SCTV01E Group and mRNA-1273 Group in a ratio of 1:1.

Conditions

• COVID-19
• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	SCTV01E	one dose of SCTV01E on D0, intramuscular
BIOLOGICAL	mRNA-1273	one dose of mRNA-1273 on D0, intramuscular

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-10-01
• Completion: 2023-04-01
• First posted: 2022-04-26
• Last updated: 2022-04-26