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Clinical Trials associated with COVIVAC vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)A Phase 1/2 Randomized, Active- Controlled, Observer-blind Trial to Assess the Safety and Immunogenicity of COVIVAC Vaccine Produced by IVAC in Adults ≥ 18 and ≥ 60 Years Old in Vietnam
This prospective, single-center, randomized, placebo-controlled (phase 1) and active-controlled (phase 2), observer-blind Phase 1/2 study includes two separate parts.
After completing the phase 1 interim analysis, 2 doses (3mcg and 6mcg) were selected for phase 2.
In Part 2 of this combined Phase 1/2 study, 374 adults aged 18-75 years will be randomized (1:1:1) to AZD1222, or COVIVAC 3 µg being evaluated in Phase 1 or the intermediate dose of COVIVAC 6 µg being selected after consideration of phase 1 results.
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years (Clinical Trials, Phase III)
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
Start Date07 Jul 2021 |
Sponsor / Collaborator- |
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) for Adults Aged 60 Years and Older
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products" for Adults Aged 60 Years and Older
Start Date01 Jul 2021 |
Sponsor / Collaborator- |
100 Clinical Results associated with COVIVAC vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)
100 Translational Medicine associated with COVIVAC vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)
100 Patents (Medical) associated with COVIVAC vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)
100 Deals associated with COVIVAC vaccine(Institute Of Vaccines And Medical Biologicals, Vietnam)