Trial · NCT01720277
High Dose Influenza Vaccine in Nursing Home - Pilot Study
NCT01720277, Phase 4, Completed, Insight Therapeutics, LLC; results first posted 2018-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. High Dose Influenza Vaccine in Nursing Home - Pilot Study. Trials, record NCT01720277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01720277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Influenza Vaccine in Nursing Home - Pilot Study
- NCT number
- NCT01720277
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,957 participants, actual
- Lead sponsor
- Insight Therapeutics, LLC
- Conditions
- Influenza
- Interventions
- HD Fluzone Vaccine, SD Fluzone Vaccine
- First posted
- 2012-11-02
- Last updated
- 2018-05-23
- Results first posted
- 2018-04-18
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total All-cause Hospitalizations | 1 year | The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS). |
| Secondary | Change in Residents' Functional Status | 1 year | 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. |
| Other | Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | 1 year | This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total All-cause Hospitalizations | 1 year | We identified long-stay nursing home residents and evaluated outcomes (e.g. hospitalizations, functional status). | events | NUMBER |
| SECONDARY | Change in Residents' Functional Status | 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | 1 year | Nursing home facilities randomized to receive high dose or standard dose vaccine. | Nursing Homes | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total All-cause Hospitalizations | High-Dose Vaccine for Residents | 197 | events | ||
| Total All-cause Hospitalizations | Standard-dose for Residents | 301 | events | ||
| Change in Residents' Functional Status | HD Fluzone Vaccine | 196 | Participants | ||
| Change in Residents' Functional Status | SD Fluzone Vaccine | 206 | Participants | ||
| Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | HD Fluzone Vaccine | 20 | Nursing Homes | ||
| Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size | SD Fluzone Vaccine | 19 | Nursing Homes |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | High-Dose Vaccine for Residents | 1,461 | 20 |
| Overall Study | STARTED | Standard-dose for Residents | 1,496 | 19 |
| Overall Study | COMPLETED | High-Dose Vaccine for Residents | 958 | 20 |
| Overall Study | COMPLETED | Standard-dose for Residents | 938 | 19 |
| Overall Study | NOT COMPLETED | High-Dose Vaccine for Residents | 503 | 0 |
| Overall Study | NOT COMPLETED | Standard-dose for Residents | 558 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | High-Dose Vaccine for Residents | 249 | 1,461 |
| Total, all-cause mortality | Standard-dose for Residents | 274 | 1,496 |
| Total, other adverse events | High-Dose Vaccine for Residents | 0 | 0 |
| Total, other adverse events | Standard-dose for Residents | 0 | 0 |
| Total, serious adverse events | High-Dose Vaccine for Residents | 0 | 0 |
| Total, serious adverse events | Standard-dose for Residents | 0 | 0 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| High-Dose Vaccine for Residents vs Standard-dose for Residents: deaths from any cause | Trial comparisons |
| HD Fluzone Vaccine vs SD Fluzone Vaccine: Change in Residents' Functional Status | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01720277
GET https://conductscience.org/api/trials/v1/NCT01720277/registered