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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 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-04-26

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SCTV01E

one dose of SCTV01E on D0, intramuscular

BIOLOGICAL

mRNA-1273

one dose of mRNA-1273 on D0, intramuscular

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05345873 on ClinicalTrials.gov