CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 577 enrolled
Drug / intervention
Flublok™ Quadrivalent by Sanofi, Inc. +1 morebiological
Likely dose
Flublok™ Quadrivalent by Sanofi, Inc. 0.5 mLfrom 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/NCT04523324
NCT04523324Phase 4Completed
CompareCT.gov

Randomized Comparison of the Immunogenicity of Recombinant and Egg-based Influenza Vaccines Among Healthcare Personnel in Israel

Centers for Disease Control and Prevention·interventional·Posted Aug 21, 2020·Updated Nov 15, 2023

In Brief

A Phase 4 clinical trial evaluating Flublok™ Quadrivalent by Sanofi, Inc. and VaxigripTetra™ by Sanofi, Inc. for Influenza. Completed, enrolled 577 participants across 2 sites.

Detailed Summary

This randomized, open-label, active-controlled trial will assess humoral immune responses to a single dose of 2019-20 recombinant hemagglutinin quadrivalent influenza vaccines (RIV4) compared with standard egg-based unadjuvanted quadrivalent influenza vaccines (IIV4) among healthcare personnel (HCP) vaccinated during the previous 2018-19 season with IIV4. The trial will be conducted at two hospital sites in Israel during the 2019-20 influenza season among HCP who were enrolled in the Study of Healthcare Personnel with Influenza and other Respiratory Viruses in Israel (SHIRI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesIsrael
CollaboratorsAbt Associates, Clalit Research Institute, Soroka University Medical Center, Rabin Medical Center, University of Michigan

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 21, 2020
Enrollment StartOct 31, 2019
Primary CompletionJan 30, 2020
Study CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago

Interventions

Flublok™ Quadrivalent by Sanofi, Inc.biological

0.5 mL intramuscular dose of Flublok

VaxigripTetra™ by Sanofi, Inc.biological

0.5 mL intramuscular dose of Vaxigrip