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Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

NCT04176133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-06-22

Study results available
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Summary

Researchers are evaluating the safety and effectiveness of a single administration of entolimod when administered at the same time as the influenza vaccine (flu vaccine).

Conditions

  • Healthy

Interventions

DRUG

Entolimod

Intramuscular (IM) single dose administration. Entolimod is provided as a sterile, clear, colorless or slightly yellow liquid for IM injection.

DRUG

Placebo

Intramuscular (IM) single dose administration, no active ingredient. A matching placebo is provided as a sterile, clear, colorless to slightly yellow liquid for IM injection in prefilled vials that are identical in appearance to the vials containing active drug.

DRUG

Influenza vaccine

Intramuscular (IM) single dose administration. Fluzone, high-dose split virion influenza virus vaccine, Sanofi Pasteur

Sponsors & Collaborators

  • Genome Protection, Inc.

    collaborator INDUSTRY

  • Robert J. Pignolo

    lead OTHER

Principal Investigators

  • Robert Pignolo, MD, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2022-03-30
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04176133 on ClinicalTrials.gov