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Recombinant COVID-19 Vaccine (CHO Cell, NVSI-06-09) Phase III Clinical Trial

NCT05599516 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16000

Last updated 2022-11-10

No results posted yet for this study

Summary

This clinical trial adopts a randomized, double-blind and placebo-controlled design.

A total of 16000 participants are planned to be enrolled, of which, Cohort 1: 15000 participants vaccinated with ≥2 doses of inactivated COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1:1 with 1 dose of LIBP-Rec-Vaccine, BIBP-Rec-Vaccine or placebo intramuscularly to the deltoid muscle of upper arm.

Cohort 2: 1000 participants vaccinated with ≥2 doses of mRNA COVID-19 vaccine for ≥6 months will be randomly administered at ratio of 1:1 with 1 dose of LIBP-Rec-Vaccine or BIBP-Rec-Vaccine intramuscularly to the deltoid muscle of upper arm.

Conditions

Interventions

BIOLOGICAL

LIBP-Rec-Vaccine

Intramuscular injection of LIBP-Rec-Vaccine in the deltoid muscle of the upper arm

BIOLOGICAL

BIBP-Rec-Vaccine

Intramuscular injection of BIBP-Rec-Vaccine in the deltoid muscle of the upper arm

BIOLOGICAL

placebo

Intramuscular injection of placebo in the deltoid muscle of the upper arm

Sponsors & Collaborators

  • China National Biotec Group Company Limited

    collaborator INDUSTRY

  • Lanzhou Institute of Biological Products Co., Ltd

    collaborator INDUSTRY

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • National Vaccine and Serum Institute, China

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2023-10-31
Completion
2023-12-31

Countries

  • United Arab Emirates

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Drugs
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 NCT05599516 on ClinicalTrials.gov