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Study of Gam-COVID-Vac in Adolescents

NCT04954092 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2021-09-16

No results posted yet for this study

Summary

Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents

Conditions

  • Covid19
  • Vaccine Preventable Disease

Interventions

BIOLOGICAL

Gam-COVID-vac M

The vaccine consists of two components: component I and component II. Component I includes a recombinant adenoviral vector based on human adenovirus serotype 26 carrying the gene for the S-protein of the SARS-CoV-2 virus, component II includes a vector based on human adenovirus serotype 5 carrying the protein S gene of the SARS-CoV-2 virus

BIOLOGICAL

Placebo

Composition without active ingredients

Sponsors & Collaborators

  • Moscow Healthcare Department

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Anna Vlasova · Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health

  • Svetlana Borzakova · Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2022-11-06
Completion
2023-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT04954092 on ClinicalTrials.gov