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NCT04560881

Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (COVID-19)

Completed Phase 3 Last updated 12 January 2022
What this trial tests

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.

Timeline
16 September 2020
Primary endpoint
13 December 2021
13 December 2021

Quick facts

Lead sponsorLaboratorio Elea Phoenix S.A.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment3,000
Start date16 September 2020
Primary completion13 December 2021
Estimated completion13 December 2021
Sites4 locations across Argentina

Drugs / interventions tested

Conditions studied

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):

  1. Viral targets for vaccines against COVID-19.
    Dai L, Gao GF. · · 2021 · cited 836× · PMID 33340022 · DOI 10.1038/s41577-020-00480-0
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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

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