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Clinical trial

Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes

ID
Name
INSI-201603
Description
This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).
Trial arms
Trial start
2016-04-01
Estimated PCD
2018-10-04
Trial end
2023-01-25
Status
Completed
Phase
Early phase I
Treatment
adjuvanted trivalent influenza vaccine
Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
Arms:
aTIV
Other names:
Fluad, aTIV
trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Arms:
TIV, aTIV
Other names:
Fluvirin, TIV
Size
823
Primary endpoint
Hospitalization for a respiratory-related Illness
up to 1 year
Hospitalization for all causes
up to 1 year
Eligibility criteria
Inclusion Criteria: * Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites Exclusion Criteria: * Facilities that used high dose influenza vaccine in residents over age 65 in previous influenza season (2015-16) * Facilities having fewer than 50 long-stay residents * Hospital-based facilities * Facilities with more than 20% of the population under age 65 * Facilities not submitting Minimum Data Set (MDS) data
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 823, 'type': 'ACTUAL'}}
Updated at
2023-03-15

1 organization

2 products

2 indications

Organization
Insight Therapeutics
Product
Adjuvanted Trivalent Influenza Vaccine
Indication
Influenza
Indication
Influenza-like illness
Product
trivalent influenza vaccine