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Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light

NCT04741061 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2021-02-21

No results posted yet for this study

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 associated with the same medical product under similar protocols. The key objective of this study is to be conducted in several parallel studies of the same vaccine above the other countries. Using similar protocols on a portfolio basis of studies let us collect data for Efficacy, Immunogenicity, Safety and Tolerability confirmation of the Sputnik-Light vaccine.

Conditions

  • COVID-19 Prevention

Interventions

BIOLOGICAL

Sputnik Light

Sputnik-Light vector vaccine: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose.

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Russian Direct Investment Fund

    collaborator INDUSTRY

  • CRO: iPharma

    collaborator UNKNOWN

  • Government of the city of Moscow

    collaborator UNKNOWN

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
111 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2021-12-31
Completion
2022-01-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741061 on ClinicalTrials.gov