Status:
UNKNOWN
Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborating Sponsors:
Russian Direct Investment Fund
CRO: iPharma
Conditions:
COVID-19 Prevention
Eligibility:
All Genders
18-111 years
Phase:
PHASE3
Brief Summary
The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe in United Arab Emirates, Russia and possibly in other countries in case of confirmation a...
Detailed Description
This study is randomized, double-blind (blinded for the study subject and investigators), placebo-controlled international multicenter study in the parallel assignment of the subjects to assess effica...
Eligibility Criteria
Inclusion
- Agree to sign the study informed consent form (ICF) before performing any study specific procedure
- Adults ≥ 18 years old
- Negative COVID-19 PCR test result at the screening visit and negative immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment
- Consent for using effective methods of contraception during the study
- No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history
- No acute infectious and/or respiratory diseases within at least 14 days before the enrolment
Exclusion
- Any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment
- Any previous or planning COVID-19 vaccination with any other Regulatory approved vaccine
- Positive SARS-CoV-2 screening result obtained by PCR (at screening)
- Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- Pregnancy or lactation
- Acute coronary syndrome or stroke suffered less than one year before study enrollment
- Tuberculosis, chronic systemic infections associated with Immunocompromised subjects in medical history
- History of severe allergic reaction to drug or vaccine (anaphylactic shock, Quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day
- Chronic autoimmune disease and system collagenases in medical history
- Organ transplantation and immunosuppressive therapy
- Immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment
- Subjects with malignant neoplasms within 5 years before the enrollment
- Splenectomy in the past medical history
- Neutropenia (absolute neutrophil count \<1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/L), immunodeficient disease in the medical history within 6 months before the enrollment
- The active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
- Acute Kidney injury or dialysis
- Anorexia or dysnutrition
- Tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo
- Alcohol or Drug abuse in medical history
- Participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial
- Any other condition that the investigator considers as a barrier to the trial completion as per the protocol
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
6000 Patients enrolled
Trial Details
Trial ID
NCT04741061
Start Date
February 19 2021
End Date
January 31 2022
Last Update
February 21 2021
Active Locations (15)
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1
Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"
Kaliningrad, Russia
2
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow, Russia
3
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
Moscow, Russia
4
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
Moscow, Russia