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Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III

NCT05096845 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22500

Last updated 2023-04-25

No results posted yet for this study

Summary

A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

Conditions

  • COVID-19 Pandemic

Interventions

BIOLOGICAL

Recombinant SARS-CoV-2 fusion protein vaccine (V-01)

Appearance: creamy white suspension Dosage form: Suspension for injection Strength: 10 μg (0.5mL) /vial Vaccination route: intramuscular injection into the lateral deltoid of the upper arm Vaccination dosage: 10 μg Immunization schedule: two doses, one each on Day 0 and 21 (+7 days), respectively. Storage condition: store at 2\~8°C protected from light Expiry date: 24 months after production date

OTHER

Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

The dosage, appearance, administration method, and other aspects are consistent with that of investigational vaccine, except that no vaccine antigen is contained.

Sponsors & Collaborators

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2022-02-08
Completion
2023-06-14

Countries

  • Indonesia
  • Philippines
  • Russia

Study Locations

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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 NCT05096845 on ClinicalTrials.gov