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A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines

NCT05933512 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2023-07-06

No results posted yet for this study

Summary

This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.

Conditions

Interventions

BIOLOGICAL

SCTV01E-2

intramuscular injection

BIOLOGICAL

SCTV01E

intramuscular injection

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-10
Primary Completion
2023-12-10
Completion
2024-11-10

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Entities

Diseases

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 NCT05933512 on ClinicalTrials.gov