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Clinical trial

Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes

ID
Name
INSI-201902
Description
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.
Trial arms
Trial start
2019-07-20
Estimated PCD
2023-08-01
Trial end
2023-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Recombinant Influenza Vaccine
Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.
Arms:
RIV4
Other names:
Flublok, RIV4
Standard Dose Quadrivalent Influenza Vaccine
Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine
Arms:
IV4
Other names:
IV4
Size
1989
Primary endpoint
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
Up to 8 months each influenza season
Eligibility criteria
Inclusion Criteria: * Medicare-certified NHs with at least 50 long-stay residents ≥ 18 years of age * Facilities with at least 80% of their long-stay population ≥ 65 years of age or at least 70 long stay residents ≥ 65 years of age that make up ≥ 45% of their total number of beds Exclusion Criteria: * Hospital-based facilities * Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season * Facilities not submitting MDS data * Facilities not in one of the 50 U.S. states
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1989, 'type': 'ACTUAL'}}
Updated at
2023-03-15

1 organization

2 products

3 indications

Organization
Insight Therapeutics
Product
Recombinant Influenza Vaccine
Indication
Influenza
Indication
Influenza-like Illness
Indication
Human
Product
Standard Dose Quadrivalent Influenza Vaccine