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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)

Primary Purpose

Coronavirus Infections, Vaccine

Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
The data from volunteers from the control group
Sponsored by
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus Infections focused on measuring COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Volunteers must meet the following inclusion criteria:

Type of participants * Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.

Age at the time of signing the Informed Consent * from ≥ 18 to < 60 years.

Paul * Male or female.

The volunteers of the study group must meet the following additional inclusion criteria:

  • Written Informed consent of volunteers to participate in a clinical trial.
  • Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits).

    • For women capable of childbirth - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Women should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile, or in a postmenopausal state.
    • For men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile.

Exclusion Criteria:

  • Volunteers cannot be included in the study if any of the following criteria are present:

SARS-CoV-2 infection

* A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.

Diseases or medical conditions

  • Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems.
  • Is registered at the dispensary for tuberculosis, leukemia, oncological diseases, autoimmune diseases.

    • Any confirmed or suspected immunosuppressive or immunodeficiency condition in the anamnesis.

  • Splenectomy in the anamnesis.
  • Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l) according to anamnesis.
  • Anorexia.

Prior or concomitant therapy

  • Vaccination with any vaccine carried out within 30 days before vaccination / the first dose of the studied vaccine or planned administration within 30 days after vaccination / the last dose of the studied vaccine.
  • Prior vaccination with an experimental or registered vaccine that may affect the interpretation of the study data (any coronavirus or SARS vaccines).
  • Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs (immunoregulatory peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon) during the six months preceding the study, according to anamnesis.
  • Treatment with glucocorticosteroids (≥ 20 mg of prednisone, or an analog, for more than 15 days during the last month).
  • Volunteers who received immunoglobulin preparations or blood transfusion during the last 3 months before the start of the study according to anamnesis.

Other non-inclusion criteria

* Pregnancy or breast-feeding. Participation in any other clinical trial within the last 3 months.

Volunteers of the study group cannot be included in the study if any of the following criteria are present:

Diseases or medical conditions

  • Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
  • Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.)•
  • Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
  • The axillary temperature at the time of vaccination is more than 37.0 ° C.
  • Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis.
  • Donation of blood or plasma (in the amount of 450 ml or more) less than 2 months before inclusion in the study.

Exclusion criteria:

  • Withdrawal of Informed consent by a volunteer;

    * The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;

    • Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;

    * The established fact of pregnancy before the second vaccination;

    * The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;

    * For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.

Sites / Locations

  • Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of RussiaRecruiting
  • RUSAL Medical Center LLCRecruiting
  • FSBSI Chumakov FSC R&D IBP RASRecruiting
  • FSBI NIIVS named after I.I. MechnikoRecruiting
  • GBUZ "State Design Bureau named after D.D. Pletnev DZM"
  • "Scientific Research Institute of Occupational Medicine named after Academician N.F. Izmerov" (FGBNU "Research Institute of MT")Recruiting
  • CHUZ "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"Recruiting
  • Limited Liability Company "H-Clinic" (LLC "H-Clinic")Recruiting
  • JSC "Medical services" CDL named after N.A.SemashkoRecruiting
  • Mmc Sogaz LlcRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The study group consisted of 3,500 volunteers who received the CoviVac vaccine

Control group

Arm Description

Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days and revaccinated at 6 months with one dose of the KoviVac vaccine. Cohort 1 - The first 1000 volunteers of the study group will be used to assess the efficacy + safety + immunogenicity of the vaccine under study. Cohort 2 - Next 1100 volunteers of the study group will be used to analyze the efficacy + safety of the vaccine under study. Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study.

The data from volunteers from the control group will be used to evaluate the effectiveness of the investigational vaccine.

Outcomes

Primary Outcome Measures

Efficasy assessment
The proportion of vaccinated volunteers who do not have laboratory and clinically confirmed COVID-19 disease within 12 months after the second vaccination for all volunteers

Secondary Outcome Measures

Classification by severity of COVID-19
The proportion of study subjects with mild, moderate, severe and extremely severe COVID-19 that developed within 12 months after receiving the second dose of the vaccine from the total number of vaccinated for all volunteers.
The proportion of study subjects who died
The proportion of study subjects who died as a result of COVID-19 out of the number of cases for all volunteers.
The duration of laboratory and clinically confirmed COVID-19 disease.
The duration of laboratory and clinically confirmed COVID-19 disease
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response in the form of an increase in geometric titers of specific antibodies (SGT) in the neutralization reaction and ELISA reaction." Only in cohort 1 of subgroup 1and subgroup 2.
Titer of specific antibody titer ≥ 4 times baseline Specific antibody titer ≥ 4 times baseline
The proportion of volunteers from the total number of vaccinated / revaccinated with a level of seroconversion (titer of specific antibodies ≥ 4 times from the initial level) in the virus neutralization reaction and the ELISA reaction. Only in cohort 1 of subgroup 1 and subgroup 2.
The level of γ-IFN and the subpopulation composition of T-lymphocytes.
The level of γ-IFN and the subpopulation composition of T-lymphocytes. Only in cohort 1 of subgroup 1 and subgroup 2.
Safety assessment
Frequency of occurrence of serious adverse events during the study.
Safety assessment
Frequency of occurrence, type and association with vaccination of adverse events during the study.
Safety assessment
Cases of early termination of volunteers' participation in the study due to the development of frequency incidence of adverse /serious frequency of adverse events associated with the use of research drugs.

Full Information

First Posted
May 24, 2022
Last Updated
February 6, 2023
Sponsor
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
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1. Study Identification

Unique Protocol Identification Number
NCT05407142
Brief Title
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)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
The study group is planned to screen a maximum of 32,000 volunteers inclusive, of which it is planned to include 3,500 men and women aged 18 to 60 years who meet the criteria for inclusion in the study and do not have non-inclusion criteria. The study group consisted of 3,500 volunteers who received the CoviVac vaccine Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml). Cohorts: The data of the first 1000 volunteers of subgroup 1 will be used to assess the efficacy + safety + immunogenicity of the vaccine under study. The data of the next 1100 volunteers of subgroup 1 will be used to analyze the efficacy + safety of the vaccine under study. Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study Control group - official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals. The data of the control group volunteers will be used to evaluate the effectiveness of the vaccine under study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infections, Vaccine
Keywords
COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
29000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The study group consisted of 3,500 volunteers who received the CoviVac vaccine
Arm Type
Experimental
Arm Description
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days and revaccinated at 6 months with one dose of the KoviVac vaccine. Cohort 1 - The first 1000 volunteers of the study group will be used to assess the efficacy + safety + immunogenicity of the vaccine under study. Cohort 2 - Next 1100 volunteers of the study group will be used to analyze the efficacy + safety of the vaccine under study. Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study.
Arm Title
Control group
Arm Type
Other
Arm Description
The data from volunteers from the control group will be used to evaluate the effectiveness of the investigational vaccine.
Intervention Type
Biological
Intervention Name(s)
CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
Intervention Description
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml). Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
Intervention Type
Other
Intervention Name(s)
The data from volunteers from the control group
Intervention Description
Official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
Primary Outcome Measure Information:
Title
Efficasy assessment
Description
The proportion of vaccinated volunteers who do not have laboratory and clinically confirmed COVID-19 disease within 12 months after the second vaccination for all volunteers
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Classification by severity of COVID-19
Description
The proportion of study subjects with mild, moderate, severe and extremely severe COVID-19 that developed within 12 months after receiving the second dose of the vaccine from the total number of vaccinated for all volunteers.
Time Frame
12 month
Title
The proportion of study subjects who died
Description
The proportion of study subjects who died as a result of COVID-19 out of the number of cases for all volunteers.
Time Frame
12 month
Title
The duration of laboratory and clinically confirmed COVID-19 disease.
Description
The duration of laboratory and clinically confirmed COVID-19 disease
Time Frame
12 month
Title
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response
Description
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response in the form of an increase in geometric titers of specific antibodies (SGT) in the neutralization reaction and ELISA reaction." Only in cohort 1 of subgroup 1and subgroup 2.
Time Frame
12 month
Title
Titer of specific antibody titer ≥ 4 times baseline Specific antibody titer ≥ 4 times baseline
Description
The proportion of volunteers from the total number of vaccinated / revaccinated with a level of seroconversion (titer of specific antibodies ≥ 4 times from the initial level) in the virus neutralization reaction and the ELISA reaction. Only in cohort 1 of subgroup 1 and subgroup 2.
Time Frame
12 month
Title
The level of γ-IFN and the subpopulation composition of T-lymphocytes.
Description
The level of γ-IFN and the subpopulation composition of T-lymphocytes. Only in cohort 1 of subgroup 1 and subgroup 2.
Time Frame
12 month
Title
Safety assessment
Description
Frequency of occurrence of serious adverse events during the study.
Time Frame
12 month
Title
Safety assessment
Description
Frequency of occurrence, type and association with vaccination of adverse events during the study.
Time Frame
12 month
Title
Safety assessment
Description
Cases of early termination of volunteers' participation in the study due to the development of frequency incidence of adverse /serious frequency of adverse events associated with the use of research drugs.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteers must meet the following inclusion criteria: Type of participants * Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study. Age at the time of signing the Informed Consent * from ≥ 18 to < 60 years. Paul * Male or female. The volunteers of the study group must meet the following additional inclusion criteria: Written Informed consent of volunteers to participate in a clinical trial. Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits). For women capable of childbirth - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Women should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile, or in a postmenopausal state. For men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile. Exclusion Criteria: Volunteers cannot be included in the study if any of the following criteria are present: SARS-CoV-2 infection * A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months. Diseases or medical conditions Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems. Is registered at the dispensary for tuberculosis, leukemia, oncological diseases, autoimmune diseases. • Any confirmed or suspected immunosuppressive or immunodeficiency condition in the anamnesis. Splenectomy in the anamnesis. Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l) according to anamnesis. Anorexia. Prior or concomitant therapy Vaccination with any vaccine carried out within 30 days before vaccination / the first dose of the studied vaccine or planned administration within 30 days after vaccination / the last dose of the studied vaccine. Prior vaccination with an experimental or registered vaccine that may affect the interpretation of the study data (any coronavirus or SARS vaccines). Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs (immunoregulatory peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon) during the six months preceding the study, according to anamnesis. Treatment with glucocorticosteroids (≥ 20 mg of prednisone, or an analog, for more than 15 days during the last month). Volunteers who received immunoglobulin preparations or blood transfusion during the last 3 months before the start of the study according to anamnesis. Other non-inclusion criteria * Pregnancy or breast-feeding. Participation in any other clinical trial within the last 3 months. Volunteers of the study group cannot be included in the study if any of the following criteria are present: Diseases or medical conditions Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination. Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.)• Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis. The axillary temperature at the time of vaccination is more than 37.0 ° C. Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis. Donation of blood or plasma (in the amount of 450 ml or more) less than 2 months before inclusion in the study. Exclusion criteria: Withdrawal of Informed consent by a volunteer; * The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol; • Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study; * The established fact of pregnancy before the second vaccination; * The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation; * For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aydar Ishmukhametov, M.D.,Prof.,Assoc.Mem.of RAS
Phone
+7(495)841-9002
Email
sue_polio@chumakovs.su
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Malkin, M.D., Ph.D, MBA
Phone
+79031542117
Email
andrew.malkin@chumakovs.su
Facility Information:
Facility Name
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadezhda Yagovkina, M.D. Ph.D
Phone
+79127288622
Email
nad0511ya@rambler.ru
First Name & Middle Initial & Last Name & Degree
Nadezhda Yagovkina, M.D. Ph.D
Facility Name
RUSAL Medical Center LLC
City
Krasnoyarsk
ZIP/Postal Code
660111
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Rumyantseva, M.D.
Phone
+74953664429
Email
olrum@bk.ru
First Name & Middle Initial & Last Name & Degree
Olga Rumyantseva, M.D.
Facility Name
FSBSI Chumakov FSC R&D IBP RAS
City
Moscow, Russia, 108819
ZIP/Postal Code
108819
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Malkin, M.D., Ph.D, MBA
Phone
+79031542117
Email
andrew.malkin@chumakovs.su
First Name & Middle Initial & Last Name & Degree
Anastasia Korduban
Phone
+79652162032
Email
korduban_ak@chumakovs.su
Facility Name
FSBI NIIVS named after I.I. Mechniko
City
Moscow
ZIP/Postal Code
105064
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kostinov, M.D. D.Sc.
Phone
+74959174149
Email
vaccinums@gmail.ru
First Name & Middle Initial & Last Name & Degree
Michael Kostinov, M.D. D.Sc.
Facility Name
GBUZ "State Design Bureau named after D.D. Pletnev DZM"
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
"Scientific Research Institute of Occupational Medicine named after Academician N.F. Izmerov" (FGBNU "Research Institute of MT")
City
Moscow
ZIP/Postal Code
105275
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Feldblum, M.D. D.Sc.
Phone
+73422181668
Email
irinablum@mail.ru
First Name & Middle Initial & Last Name & Degree
Irina Feldblum
Facility Name
CHUZ "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
City
Moscow
ZIP/Postal Code
109386
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Popov, M.D.
Phone
+74955313055
Email
clinpharmcb6@mail.ru
First Name & Middle Initial & Last Name & Degree
Vladimir Popov, M.D.
Facility Name
Limited Liability Company "H-Clinic" (LLC "H-Clinic")
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataly Voronkova, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Nataly Voronkova, M.D. Ph.D.
Facility Name
JSC "Medical services" CDL named after N.A.Semashko
City
Moscow
ZIP/Postal Code
129329
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uruzmag Tomaev, M.D.
Phone
+76983786656
Email
umtomaev@mail.ru
First Name & Middle Initial & Last Name & Degree
Uruzmag Tomaev, M.D.
Facility Name
Mmc Sogaz Llc
City
Sankt Peterburg
ZIP/Postal Code
191186
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Obrezan, M.D.
Phone
+7 8124068888
Email
obrezanI@yandex.ru
First Name & Middle Initial & Last Name & Degree
Andrew Obrezan, M.D.

12. IPD Sharing Statement

Learn more about this trial

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)

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