drugset / Trial / 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

NCT05345873

Phase 2 Unknown 300 enrolled Sinocelltech Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2022-07-01
Primary completion
2022-10-01
Completion
2023-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Elasomeran Messenger RNA (mRNA) Intramuscular
Subject SCTV01E Vaccine Intramuscular

Indications