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NCT05374954: COVID-19
Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above
Phase 3 trial testing Omicron COVID-19 Vaccine (Vero Cell), Inactivated in COVID-19 in 4,200 participants. Status unknown.
25 September 2022
Quick facts
| Lead sponsor | China National Biotec Group Company Limited |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 4,200 |
| Start date | 10 May 2022 |
| Primary completion | 25 September 2022 |
| Estimated completion | 10 November 2023 |
| Sites | 10 locations across China |
Drugs / interventions tested
- Omicron COVID-19 Vaccine (Vero Cell), Inactivated — full drug profile →
- 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 randomized, double blind, positive controlled study to evaluate the safety and immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above who have been vaccinated with 2 or 3 doses of COVID-19 Vaccine (Vero Cell), Inactivated manufactured by Beijing Institute of Biological Products, Co., Ltd.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Challenges and developments in universal vaccine design against SARS-CoV-2 variants.
Zhao F, Zai X, Zhang Z, Xu J, et al · · 2022 · cited 55× · PMID 36535982 · DOI 10.1038/s41541-022-00597-4 -
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 -
Development of Next Generation Vaccines against SARS-CoV-2 and Variants of Concern.
Al-Fattah Yahaya AA, Khalid K, Lim HX, Poh CL. · · 2023 · cited 14× · PMID 36992333 · DOI 10.3390/v15030624
Verify or expand the search:
- PubMed search for NCT05374954
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omicron COVID-19 Vaccine (Vero Cell), Inactivated
Trials testing the same drug.
- NCT05365724 — A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 · Phase 1, PHASE2 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05374954 (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/NCT05374954.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing