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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Inactivated Influenza Vaccine | Active Comparator | 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 |
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| Standard Dose Inactivated Influenza Vaccine | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Inactivated Influenza Vaccine | Biological | 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A. Nace, MD, MPH, CMD | University of Pittsburgh, Division of Geriatric Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh, Division of Geriatric Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25525051 | Result | 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. |
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A total of 205 participants from 15 community-based LTCFs who met all inclusion and none of the exclusion criteria were enrolled.
Participants were enrolled during the 2011-2012 and 2012-2013 influenza seasons
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| ID | Title | Description |
|---|---|---|
| FG000 | HD IIV | Frail adults 65 years or older who received Fluzone High Dose intramuscularly. |
| FG001 | SD IIV | Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HD IIV | Frail adults 65 years and older who received Fluzone High Dose intramuscularly |
| BG001 | SD IIV | Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | titers | 30 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HD IIV | Frail adults 65 years or older who received Fluzone High Dose intramuscularly. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Nace, MD, MPH | University of Pittsburgh | 412 692-2366 | naceda@upmc.edu |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Standard Dose Inactivated Influenza Vaccine | Biological | 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin |
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| Insufficient blood sample |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Standard Dose Inactivated Influenza Vaccine | 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 Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin |
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|
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| Secondary | 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 | The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected. | Posted | Geometric Mean | 90% Confidence Interval | Titers | 6 months |
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|
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| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 |
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| 0 |
| 89 |
| 0 |
| 89 |
| EG001 | SD IIV | Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly | 0 | 98 | 0 | 98 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B/Brisbane/60/2008 |
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| A/California/07/2009(H1N1) @012-2013 Season |
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| A/Victoria/361/2011(H3N2) |
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| B/Texas/6/2011 |
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| t-test, 2 sided |
| .006 |
A/Victoria/210/2009(H3N2) |
| Non-Inferiority or Equivalence |
An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .069 | B/Brisbane/60/2008 | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .663 | A/California/07/2009(H3N2) | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .003 | A/Victoria/361/2011(H3N2) | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .063 | B/Texas/6/2011 | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| B/Brisbane/60/2008 |
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| A/California/07/2009(H1N1) 2012-2013 Season |
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| A/Victoria/361/2011(H3N2) |
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| B/Texas/6/2011 |
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| t-test, 2 sided |
| .360 |
A/Victoria/210/2009(H3N2) |
| Non-Inferiority or Equivalence |
An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .248 | B/Brisbane/60/2008 | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .178 | A/California/07/2009(H1N1) | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .152 | A/Victoria/361/2011(H1N2) | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |
| t-test, 2 sided | .285 | B/Texas/6/2011 | Non-Inferiority or Equivalence | An upper bound >0.67 of the 2-sided 95% CI of the ratio of postvaccination GMTHD to GMTSD indicated noninferiority. A lower bound of ≥1.0 of the 2-sided 95% CI of the ratio of GMTHD to GMTSD indicated superiority. |