Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Influenza Clinical Trial

Official title:

Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654224
• Other study ID #: PRO10110247
• Status: Completed
• Phase: Phase 4
• First received: July 27, 2012
• Last updated: July 6, 2015
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: University of Pittsburgh IRBUnited States: Pennsylvania Department of Health IRB
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• High Dose Inactivated Influenza Vaccine
0.5 ml HDIV consisting of 180 mcg (60 mcg 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

Locations

Country	Name	City	State
United States	University of Pittsburgh, Division of Geriatric Medicine	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 days	No
Secondary	Non-inferiority and immunoprotection persistence at 6 months and the impact of potential immune modulators on titer response	Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents and potential modifiers of immune response	6 months	No