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Comparison · NCT01720277-eefb5b81

HD Fluzone Vaccine vs SD Fluzone Vaccine: Change in Residents' Functional Status

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. HD Fluzone Vaccine vs SD Fluzone Vaccine: Change in Residents' Functional Status. Trial comparisons, record NCT01720277-eefb5b81. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01720277-eefb5b81

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1340.1180.153wilson
Risk in group 20.1380.1210.156wilson
Risk difference, group 1 minus group 2-0.00355-0.02830.0212newcombe hybrid score
Risk ratio, group 1 over group 20.9740.8121.17log
Odds ratio, group 1 over group 20.970.7861.2log
Number needed to treat, for one fewer participant with the outcome on HD Fluzone Vaccine than on SD Fluzone Vaccine282from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1HD Fluzone Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.~HD Fluzone Vaccine: Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).
1961,461OG000
Group 2SD Fluzone Vaccine
NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.~SD Fluzone Vaccine: Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
2061,496OG001

Outcome

Type
SECONDARY
Title
Change in Residents' Functional Status
Description
The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.
Time frame
1 year
Population

Source ClinicalTrials.gov

Trial

Title
High Dose Influenza Vaccine in Nursing Home - Pilot Study
NCT number
NCT01720277
Phases
PHASE4
Conditions
Influenza
Interventions
HD Fluzone Vaccine, SD Fluzone Vaccine
Lead sponsor
Insight Therapeutics, LLC
Results first posted
2018-04-18

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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