Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
High Dose Inactivated Influenza Vaccine
Standard Dose Inactivated Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza in Long Term Care Setting, High dose Inactivated influenza vaccine, Standard dose inactivated influenza vaccine
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
Sites / Locations
- University of Pittsburgh, Division of Geriatric Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High Dose Inactivated Influenza Vaccine
Standard Dose Inactivated Influenza Vaccine
Arm Description
For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin
For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin
Outcomes
Primary Outcome Measures
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.
Secondary Outcome Measures
Non-inferiority and Immunoprotection Persistence at 6 Months
Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents
Full Information
NCT ID
NCT01654224
First Posted
July 27, 2012
Last Updated
June 13, 2017
Sponsor
University of Pittsburgh
Collaborators
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01654224
Brief Title
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Official Title
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Influenza and pneumonia are the fifth leading cause of death in the United States, the leading cause of vaccine preventable death, and the leading cause of infection related deaths among nursing home residents(Nace, Drinka et al.2010). Each year, an estimated 36,000 individuals die from seasonal influenza and over 90% of these deaths occur among older adults, primarily the frail older adults residing in LTC settings(Fiore,Uyeki et al. 2010).Vaccination is the most effective means of preventing influenza (Nichol and Treanor 2006). Despite increasing success in immunizing LTC residents though, outbreaks continue to occur annually with case fatality rates ranging between 5-55% (Nace 2008). Older adults have a reduced response to influenza vaccination, in part due to age related immunosenescence (Keitel, Atmar et al. 1121; Skowronski, Tweed et al. 2008). It is widely recognized that more effective vaccine options are needed for frail older adults. One option is to increase the hemagglutinin (HA) dose in influenza vaccines in an effort to increase antibodies to hemagglutinin. To date, no studies have evaluated the effectiveness of the HDIV among LTC residents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza in Long Term Care Setting, High dose Inactivated influenza vaccine, Standard dose inactivated influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Inactivated Influenza Vaccine
Arm Type
Active Comparator
Arm Description
For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin
Arm Title
Standard Dose Inactivated Influenza Vaccine
Arm Type
Active Comparator
Arm Description
For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin
Intervention Type
Biological
Intervention Name(s)
High Dose Inactivated Influenza Vaccine
Intervention Description
0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin
Intervention Type
Biological
Intervention Name(s)
Standard Dose Inactivated Influenza Vaccine
Intervention Description
0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
Primary Outcome Measure Information:
Title
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
Description
The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.
Time Frame
30 days
Title
Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings
Description
The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Non-inferiority and Immunoprotection Persistence at 6 Months
Description
Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Nace, MD, MPH, CMD
Organizational Affiliation
University of Pittsburgh, Division of Geriatric Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh, Division of Geriatric Medicine
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25525051
Citation
Nace DA, Lin CJ, Ross TM, Saracco S, Churilla RM, Zimmerman RK. Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities. J Infect Dis. 2015 Jun 15;211(12):1915-24. doi: 10.1093/infdis/jiu622. Epub 2014 Dec 17.
Results Reference
result
Learn more about this trial
Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
We'll reach out to this number within 24 hrs