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Single-center, Randomized, Double-blind, Placebo-controlled Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells) in Healthy People Aged 6-17 Years
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).
Details
| Lead sponsor | WestVac Biopharma Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | WITHDRAWN |
| Start date | 2024-07 |
| Completion | 2025-12 |
Conditions
- COVID-19
Interventions
- Recombinant COVID-19 vaccine (Sf9 cells)
- Placebo control
Primary outcomes
- Phase I clinical trial：The incidence of adverse reactions (ARs) . — Day 0-7 days after each vaccination.
Adverse reactions (ARs) in each dose group 0-7 days after each vaccination. - Phase II clinical trial：The incidence of adverse reactions (ARs) . — Day 0-7 days after each vaccination.
Adverse reactions (ARs) in 0-7 days after each vaccination. - Phase II clinical trial：The geometric mean titer(GMT) of specific antibody. — Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of the S-RBD protein-specific IgG antibody against SARS-CoV-2. - Phase II clinical trial：The geometric mean titer(GMT) of specific antibody. — Day 30 after completion of 3 doses vaccination
The geometric mean titer (GMT) of anti-SARS-CoV-2 specific neutralizing antibody (neutralization test method for live virus and/or pseudovirus).
Countries
China