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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
David Nace, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01654224
First received: July 27, 2012
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: High Dose Inactivated Influenza Vaccine
Biological: Standard Dose Inactivated Influenza Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 and the impact of potential immune modulators on titer response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 320
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Dose Inactivated Influenza Vaccine
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
Biological: High Dose Inactivated Influenza Vaccine
0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin
Active Comparator: 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
Biological: 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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654224

Contacts
Contact: David A. Nace, MD, MPH,CMD (412) 692-2360 naceda@upmc.edu
Contact: Stacey Saracco, RN (412) 692-2348 saraccos@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh, Division of Geriatric Medicine Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Stacey Saracco, RN    412-692-2348    saraccos@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Sanofi Pasteur, a Sanofi Company
Investigators
Principal Investigator: David A. Nace, MD, MPH, CMD University of Pittsburgh, Division of Geriatric Medicine
  More Information

No publications provided

Responsible Party: David Nace, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01654224     History of Changes
Other Study ID Numbers: PRO10110247
Study First Received: July 27, 2012
Last Updated: May 31, 2013
Health Authority: United States: University of Pittsburgh IRB
United States: Pennsylvania Department of Health IRB

Keywords provided by University of Pittsburgh:
Influenza in Long Term Care Setting
High dose Inactivated influenza vaccine
Standard dose inactivated influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014