Phase 4
Completed N=205
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Source: ClinicalTrials.gov NCT01654224 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings — 78.2; 27.4; 26.2; 10.2 titers — p=.005
◆ Published Evidence
Established
45citations · ~4 / year
Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.
Summary
The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults.
Linked Publications
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Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings |
17.1; 16.6; 8.9; 7.3; 15.3; 11.6 | .917 |
| PRIMARY Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings |
17.1; 16.6; 8.9; 7.3; 15.3; 11.6 | .917 |
| SECONDARY Non-inferiority and Immunoprotection Persistence at 6 Months |
59.7; 28.3; 22.3; 9.4; 22.9; 15.4 | .074 |
Eligibility Criteria
Inclusion Criteria
- Residents of one of the participating LTC sites
- 65 years or older at the time of consent
- require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff
Exclusion Criteria
- Age less than 65 years
- Life expectancy less than 6 months
- History of allergic reaction to influenza vaccine, its components, or eggs
- History of severe allergic reaction to latex
- History of Guillian-Barre Syndrome
- Actively undergoing chemotherapy
- Actively undergoing radiation therapy
- Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days
- Serious current immunosuppression or immunosuppression expected in the next 6 weeks
- Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives
Data sourced from ClinicalTrials.gov (NCT01654224) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.