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A Double-blind Randomized Placebo-controlled Study Study of the Safety, Reactogenicity and Immunogenicity of the GamFluVac

NCT04034290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2020-08-25

No results posted yet for this study

Summary

The aim of the present study is at the first stage: a comparative assessment of the safety of the two methods of vaccine administration, at the second - an assessment of the safety and state of post-vaccination immunity at different times after vaccination

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

GamFluVac

The drug is a vaccine that induces high-level immunity against influenza A viruses

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Main military clinical hospital named after academician N. N. Burdenko

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Irina Gagarina, MD, PhD · Federal state budgetary institution " Main military clinical hospital named after academician N. N. Burdenko " of the Ministry of Defence of the Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-18
Primary Completion
2020-06-30
Completion
2020-07-31

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 NCT04034290 on ClinicalTrials.gov