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Clinical Trial of Recombinant COVID-19 Vaccine (Sf9 Cells) in Children and Adolescents

NCT05013983 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-03-28

No results posted yet for this study

Summary

This is a phase Ⅰ/Ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the safety, tolerability and immunogenicity of the recombinant COVID-19 vaccine (Sf9 cells) in the subjects from healthy aged 6-17 years with immunization procedures 0, 21, 42 days and doses (10μg/20μg/40μg).

Conditions

Interventions

BIOLOGICAL

Recombinant COVID-19 vaccine (Sf9 cells)

This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified

OTHER

Placebo control

Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • WestVac Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengcai Zhu · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT05013983 on ClinicalTrials.gov