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Immunogenicity Trial of Recombinant Influenza Vaccine Among HCP in Israel

NCT04523324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2023-11-15

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

Flublok™ Quadrivalent by Sanofi, Inc.

0.5 mL intramuscular dose of Flublok

BIOLOGICAL

VaxigripTetra™ by Sanofi, Inc.

0.5 mL intramuscular dose of Vaxigrip

Sponsors & Collaborators

Principal Investigators

  • Mark G Thompson, PhD · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2020-01-30
Completion
2022-08-30
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Entities

Diseases
Companies

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 NCT04523324 on ClinicalTrials.gov