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Clinical Study of Recombinant Novel Coronavirus（COVID-19） Vaccine (CHO Cell) Combined With Influenza Vaccine

NCT05107375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2023-06-08

No results posted yet for this study

Summary

Popular topic：Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and over. Overall design:An open experimental design was adopted in this study, and 300 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The study involved people 18 years of age and older.

Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60 patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in 18-59 years old group and 30 cases in ≥60 years old group.

Conditions

  • Coronavirus Disease 2019

Interventions

BIOLOGICAL

Tetravalent influenza virus lysis vaccine

Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cell) group

One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein.

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tao Huang · Hunan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-03-04
Completion
2022-03-04

Countries

  • China

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 NCT05107375 on ClinicalTrials.gov