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NCT04560881
Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)
Phase 3 trial testing Inactivated SARS-CoV-2 vaccine (Vero cell) in COVID-19 Virus Infection in 3,000 participants. Completed in 13 December 2021.
13 December 2021
Quick facts
| Lead sponsor | Laboratorio Elea Phoenix S.A. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 3,000 |
| Start date | 16 September 2020 |
| Primary completion | 13 December 2021 |
| Estimated completion | 13 December 2021 |
| Sites | 4 locations across Argentina |
Drugs / interventions tested
- Inactivated SARS-CoV-2 vaccine (Vero cell)
- Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine — full drug profile →
Conditions studied
- COVID-19 Virus Infection — all drugs for COVID-19 Virus Infection →
Sponsor
Laboratorio Elea Phoenix S.A. — full company profile →
Who can join
Adults 18 to 85, any sex, with COVID-19 Virus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double blind, placebo parallel-controlled phase III clinical trial to evaluate the efficacy, immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in Argentine healthy population aged between 18 and 85 years old.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Viral targets for vaccines against COVID-19.
Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0 -
SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates.
Kyriakidis NC, López-Cortés A, González EV, Grimaldos AB, et al · · 2021 · cited 507× · PMID 33619260 · DOI 10.1038/s41541-021-00292-w -
Coronavirus vaccine development: from SARS and MERS to COVID-19.
Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2 -
COVID-19 vaccines: rapid development, implications, challenges and future prospects.
Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4 -
Efficacy and safety of COVID-19 vaccines.
Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477 -
A Comprehensive Review of the Global Efforts on COVID-19 Vaccine Development.
Li Y, Tenchov R, Smoot J, Liu C, et al · · 2021 · cited 215× · PMID 34056083 · DOI 10.1021/acscentsci.1c00120 -
COVID-19 vaccine: A recent update in pipeline vaccines, their design and development strategies.
Rawat K, Kumari P, Saha L. · · 2021 · cited 169× · PMID 33245898 · DOI 10.1016/j.ejphar.2020.173751 -
COVID-19: A review of therapeutic strategies and vaccine candidates.
Izda V, Jeffries MA, Sawalha AH. · · 2021 · cited 159× · PMID 33217545 · DOI 10.1016/j.clim.2020.108634
Verify or expand the search:
- PubMed search for NCT04560881
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT03317236 — Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine. · Phase 4 · completed
- NCT03668054 — Safety and Clinical Effectiveness of Intravitreal Bevacizumab (Lumiere®) in Patients With Wet Age-related Macular Degene · Phase 3 · completed
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 NCT04560881 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Laboratorio Elea Phoenix S.A.
- Last refreshed: 12 January 2022
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/NCT04560881.
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