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Gamaleya Research Institute Of Epidemiology And Microbiology, Health Ministry Of The Russian Federation

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Ownership: Private

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Clinical Trials

An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola

Phase 1

Completed

Conditions: Healthy

Interventions: Biological: GamEMab

First Posted Date: 2018-02-09

Last Posted Date: 2019-11-14

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 25

Registration Number: NCT03428347

Locations: 🇷🇺
Research Institute of Influenza, Sankt-Peterburg, Russian Federation

A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-Lyo

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Biological: GamEvac-Lyo
Biological: GamEvac-Lyo (component A)
Biological: GamEvac-Lyo (component B)
Other: Placebo

First Posted Date: 2017-11-07

Last Posted Date: 2019-11-14

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 220

Registration Number: NCT03333538

Locations: 🇷🇺
Research Institute of Influenza, Sankt-Peterburg, Russian Federation

Evaluation of the Safety and Immunogenicity of the Recombinant Subunit Vaccine "GamTBvac" Against the Tuberculosis.

Phase 1

Completed

Conditions: Tuberculosis

Interventions: Biological: Placebo administration
Biological: Double GamTBvac vaccination (0.25 dose)
Biological: Double GamTBvac vaccination (0.5 dose)
Biological: Double GamTBvac vaccination (1.0 dose)
Biological: Single GamTBvac vaccination (0.25 dose)

First Posted Date: 2017-08-21

Last Posted Date: 2017-12-27

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 60

Registration Number: NCT03255278

Locations: 🇷🇺
Sechenov First Moscow State Medical University, Moscow, Russian Federation

An Open Study to Assess the Safety and Pharmacokinetics of Fluorothyazinone as a Single-Dose Administration or a Treatment Course in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Fluorothyazinone 300 mg
Drug: Fluorothyazinone 600 mg
Drug: Fluorothyazinone 3900 mg

First Posted Date: 2017-07-02

Last Posted Date: 2018-07-24

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 25

Registration Number: NCT03205462

Locations: 🇷🇺
Federal State Budget-Funded Educational Institution for Additional Professional Education "Russian Medical Academy for Postgraduate Education" of the Ministry of Health of the Russian Federation, Moscow, Russian Federation

A Phase I Clinical Study of a GamLPV, a Live Intranasal Bordetella Pertussis Vaccine

Phase 1

Completed

Conditions: Whooping Cough

Interventions: Biological: Vaccine GamLPV
Other: Placebo

First Posted Date: 2017-05-03

Last Posted Date: 2017-12-28

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 36

Registration Number: NCT03137927

Locations: 🇷🇺
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department, Moscow, Russian Federation

International Multicenter Study of the Immunogenicity of Medicinal Product GamEvac-Combi

Phase 4

Completed

Conditions: Prevention
Ebola Virus Disease

Interventions: Biological: GamEvac-Combi (vaccine)
Biological: Placebo

First Posted Date: 2017-03-07

Last Posted Date: 2020-08-25

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 2000

Registration Number: NCT03072030

Locations: 🇬🇳
Centre de recherche en épidémiologie, microbiologie et de soins médicaux (CREMS) de Pastoria à Kindia, Kindia, Guinea
🇷🇺
Infectious Disease Clinical Hospital No. 1 of the Moscow Healthcare Department, Moscow, Russian Federation

Open Study of the Duration of Immunity After Vaccination With GamEvac

Completed

Conditions: Hemorrhagic Fever, Ebola

Interventions: Procedure: blood sampling collection

First Posted Date: 2016-09-22

Last Posted Date: 2017-12-27

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 60

Registration Number: NCT02911428

Locations: 🇷🇺
Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation, Saint Petersburg, Russian Federation

Open Study of the Duration of Immunity After Vaccination With GamEvac-Combi

Completed

Conditions: Ebola Hemorrhagic Fever

Interventions: Procedure: blood sampling collection

First Posted Date: 2016-09-22

Last Posted Date: 2017-12-27

Lead Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Target Recruit Count: 60

Registration Number: NCT02911415

Locations: 🇷🇺
Federal state budget military educational institution of higher education "Military medical Academy named after S. M. Kirov" Ministry of defense of the Russian Federation, Saint Petersburg, Russian Federation

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