NCT02297542

Brief Summary

This 5-year proposal is a randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard-dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a newly approved high-dose influenza vaccine in older people

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 1, 2018

Status Verified

February 1, 2018

Enrollment Period

5.2 years

First QC Date

November 3, 2014

Last Update Submit

July 31, 2018

Conditions

Elderly Immune System

Keywords

Influenza Vaccine

Outcome Measures

Primary Outcomes (1)

  • Number of Influenza Cases

    Influenza surveillance includes weekly contact with study subjects to assess for any flu-like symptoms or acute respiratory infection (ARI), and include nasopharyngeal swabs (within 5 days of onset of symptoms) for polymerase chain reaction (PCR) detection of influenza virus and post-influenza season detection of an antibody response to influenza infection. Routine screen for symptoms of ARI will also occur at the 4, 10 and 20 week visits when blood samples are collected. Influenza illness will be documented by PCR detection of influenza during an IARI or seroconversion (4-fold rise in antibody titers) in association with an ARI. ARI includes upper (coryza or sore throat) or lower (cough or shortness of breath) respiratory tract symptoms, or headache, malaise, myalgia or fever (\> 99°F or 37.3°C orally or 100°F rectally) \[41\]. as physician visits, hospitalizations and deaths attributed to acute cardiopulmonary illness and will be tracked through the influenza season.

    five years

Study Arms (2)

Flu Vaccine SD

ACTIVE COMPARATOR

Fluzone Standard Dose Influenza Vaccine

Biological: Flu Vaccine

Flu Vaccine HD

ACTIVE COMPARATOR

Fluzone High Dose Influenza Vaccine

Biological: Flu Vaccine

Interventions

Flu VaccineBIOLOGICAL
Also known as: Fluzone HD
Flu Vaccine HDFlu Vaccine SD

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent provided by the participant
  • Age 20-40 years old with no underlying chronic diseases or age ≥65 years old
  • Willing to receive influenza vaccination
  • Older cohort has received their influenza vaccine for the previous influenza season

You may not qualify if:

  • Immunosuppressive disorders or medications (including oral prednisone in doses \>10 mg daily)
  • Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination
  • Participant has received a community available influenza vaccine for the approaching influenza season
  • Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center on Aging, UConn Health

Farmington, Connecticut, 06030, United States

Location

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Related Publications (1)

  • McElhaney JE, Verschoor CP, Haynes L, Pawelec G, Loeb M, Andrew MK, Kuchel GA. Key Determinants of Cell-Mediated Immune Responses: A Randomized Trial of High Dose Vs. Standard Dose Split-Virus Influenza Vaccine in Older Adults. Front Aging. 2021 May;2:649110. doi: 10.3389/fragi.2021.649110. Epub 2021 May 21.

    PMID: 35128529DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Janet E McElhaney, MD

    Health Sciences North Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist, AMRIC, Professor (NOSM), Medical Lead for Senior's Care and Consulting Geriatrician (HSN), HSN Volunteer Association Chair in Geriatric Research

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 21, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 1, 2018

Record last verified: 2018-02

Locations

CA(1)US(1)