MedTrace Logo

Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell)

NCT05109598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-04-25

No results posted yet for this study

Summary

Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.

Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3\~17 and the age of 18\~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).

Study population:400 healthy people aged 3 to 17 years old, both male and female.

Conditions

Interventions

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cell)

Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person /dose Recombinant new coronavirus vaccine (CHO cells).

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
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2022-02-14
Completion
2023-04-06

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 NCT05109598 on ClinicalTrials.gov