Who is sponsoring NCT05365724?

NCT05365724 is sponsored by China National Biotec Group Company Limited.

What drugs are being tested in NCT05365724?

Interventions in NCT05365724: Omicron COVID-19 Vaccine (Vero Cell), Inactivated.

Is NCT05365724 still recruiting?

NCT05365724 is currently status unknown. Last updated 18 June 2023.

Last reviewed 2023-06-18 · How we verify

NCT05365724: COVID-19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above

Status unknown Phase 1, PHASE2 Last updated 18 June 2023

What this trial tests

Phase 1, PHASE2 trial testing Omicron COVID-19 Vaccine (Vero Cell), Inactivated in COVID-19 in 280 participants. Status unknown.

Timeline

1 May 2022

Primary endpoint
1 October 2023

1 October 2023

Quick facts

Lead sponsor	China National Biotec Group Company Limited
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	280
Start date	1 May 2022
Primary completion	1 October 2023
Estimated completion	1 October 2023
Sites	1 location across China

Drugs / interventions tested

Omicron COVID-19 Vaccine (Vero Cell), Inactivated — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

China National Biotec Group Company Limited — full company profile →

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months. The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A Detailed Overview of SARS-CoV-2 Omicron: Its Sub-Variants, Mutations and Pathophysiology, Clinical Characteristics, Immunological Landscape, Immune Escape, and Therapies.
Chatterjee S, Bhattacharya M, Nag S, Dhama K, et al · · 2023 · cited 230× · PMID 36680207 · DOI 10.3390/v15010167
The race for clinical trials on Omicron-based COVID-19 vaccine candidates: Updates from global databases.
Viveiros-Rosa SG, Mendes CD, Farfán-Cano GG, El-Shazly M. · · 2022 · cited 27× · PMID 38449904 · DOI 10.52225/narra.v2i3.88
Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants: a randomized phase 2 trial.
Kaabi NA, Yang YK, Liang Y, Xu K, et al · · 2023 · cited 5× · PMID 36596779 · DOI 10.1038/s41392-022-01295-2
Safety and immunogenicity of a broad-spectrum mosaic vaccine as a booster dose against SARS-CoV-2 Omicron and other circulating variants
Kaabi NA, Yang YK, Liang Y, Xu K, et al · · 2022 · DOI 10.1101/2022.09.05.22279589

Verify or expand the search:

Other trials of Omicron COVID-19 Vaccine (Vero Cell), Inactivated

Trials testing the same drug.

NCT05374954 — Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in P · Phase 3 · unknown

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other China National Biotec Group Company Limited trials

Trials by the same sponsor.

NCT07338851 — the Five-year Antibody Persistence After Immunization With IPV, MMR and HepA-L Vaccines · not yet recruiting
NCT07377175 — Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses. · Phase 1 · recruiting
NCT05839301 — A Trial to Evaluate the Lot-to-lot Consistency of Live Attenuated Varicella Vaccine in Healthy People 1-12 Years of Age · Phase 3 · unknown
NCT05669625 — A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine · Phase 3 · active not recruiting
NCT05480436 — Immunogenicity and Safety of BBIBP-Corv Coadministered With PPV23 and IIV4 in Hemodialysis Population · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05365724 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by China National Biotec Group Company Limited
Last refreshed: 18 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05365724.

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