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Recombinant Influenza Vaccination in U.S. Nursing Homes

NCT03965195 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1989

Last updated 2023-03-15

No results posted yet for this study

Summary

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

Conditions

  • Influenza
  • Influenza -Like Illness
  • Influenza, Human

Interventions

BIOLOGICAL

Recombinant Influenza Vaccine

Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.

BIOLOGICAL

Standard Dose Quadrivalent Influenza Vaccine

Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Brown University

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Insight Therapeutics, LLC

    lead OTHER

Principal Investigators

  • H. Edward Davidson, PharmD, MPH · Insight Therapeutics, LLC

  • Stefan Gravenstein, MD, MPH · Insight Therapeutics, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-20
Primary Completion
2023-08-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03965195 on ClinicalTrials.gov