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

NCT01654224 | Completed Phase 4 Results DMC

• 1 other identifier: PRO10110247
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza in Long Term Care Setting; High dose Inactivated influenza vaccine; Standard dose inactivated influenza vaccine

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Non-inferiority and Immunoprotection Persistence at 6 Months

  6 months

Study Arms (2)

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

Biological: High Dose Inactivated Influenza Vaccine

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

Biological: Standard Dose Inactivated Influenza Vaccine

Interventions

High Dose Inactivated Influenza Vaccine BIOLOGICAL

0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin

High Dose Inactivated Influenza Vaccine

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

Standard Dose Inactivated Influenza Vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Residents of one of the participating LTC sites
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (1)

University of Pittsburgh, Division of Geriatric Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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 2014 Dec 17.

  PMID: 25525051 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: David Nace, MD, MPH
• Organization: University of Pittsburgh

naceda@upmc.edu

412 692-2366

Study Officials

• David A. Nace, MD, MPH, CMD

  University of Pittsburgh, Division of Geriatric Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 2, 2017
• Results First Posted: July 14, 2016

Record last verified: 2017-06

Locations

US (1)