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Clinical Trials of the Consistency and Non-inferiority Bridging Between Batches of Recombinant New Coronavirus Vaccine (CHO Cells)

NCT05091411 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1680

Last updated 2021-10-25

No results posted yet for this study

Summary

Popular topic:Clinical trials of the consistency and non-inferiority bridging between batches of recombinant new coronavirus vaccine (CHO cells) Research purpose:Main purpose:1)To evaluate the interbatch consistency of immunogenicity of three batches of recombinant Novel Coronavirus vaccine (CHO cells) following process validation in 18-59 year olds. 2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and pilot scale batch after process validation in 18-59 years of age. Secondary purpose:1)To evaluate the safety of each batch of recombinant Novel Coronavirus vaccine (CHO cells) in patients aged 18-59 years.2)To evaluate the non-inferiority of immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) from the combined batch and commercial batch after process validation in 18-59 years of age.

Overall design:This trial adopts a randomized, double-blind, parallel controlled trial design. Study population:The study involved people aged 18-59. Test groups:A total of 1680 subjects were enrolled in this clinical trial and randomly divided into 4 groups at 1:1:1:1 (pilot scale batch: process verification batch 1: process verification batch 2: process verification batch 3) , 420 cases per group.

Conditions

  • Coronavirus Disease 2019

Interventions

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cell) group

Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant 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
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2021-11-30
Completion
2022-12-31

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 NCT05091411 on ClinicalTrials.gov