MedTrace Logo

Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

NCT05850507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2024-05-13

No results posted yet for this study

Summary

Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).

Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and older.

Overall design: Studies were randomized, double-blind, active, controlled study design.

Study group: people aged 18 years and above who have completed primary immunization or booster immunization of the new coronavirus vaccine for more than 6 months.

Study group: Randomly divided into study group and control group according to the 1:1 ratio, of which 225 subjects in the study group and 225 subjects in the control group were vaccinated with study vaccine and control vaccine respectively.

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)

Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).

BIOLOGICAL

Recombinant novel coronavirus protein vaccine (CHO cells)

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2023-10-17
Completion
2024-03-20

Countries

  • China

Study Locations

More Related Trials

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 NCT05850507 on ClinicalTrials.gov