CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 enrolled
Drug / intervention
Entolimod +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04176133
NCT04176133Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Single-Administration, Dose-Escalation Study of Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination

Robert J. Pignolo·interventional·Posted Nov 25, 2019·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating Entolimod, Placebo, and 1 other intervention for Healthy. Completed, enrolled 61 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsGenome Protection, Inc.

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartOct 30, 2019
Primary CompletionMar 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.6 years ago

Interventions

Entolimoddrug

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

Placebodrug

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.

Influenza vaccinedrug

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