NCT02565277

Brief Summary

To assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2018

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

September 30, 2015

Last Update Submit

July 28, 2020

Conditions

Systemic Inflammatory Response

Outcome Measures

Primary Outcomes (1)

  • Pro and anti-inflammatory cytokines and inflammatory markers

    Nine Months

Study Arms (2)

Influenza Vaccine

ACTIVE COMPARATOR

Fluzone injection once IM

Biological: Influenza Vaccine

Placebo

PLACEBO COMPARATOR

Saline Injection once IM

Drug: Placebo

Interventions

Influenza VaccineBIOLOGICAL
Also known as: Fluzone
Influenza Vaccine
PlaceboDRUG
Also known as: Saline Injection
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, and able to converse with study personnel)
  • Age 18 years or older
  • Undergoing major cardiac surgery using cardiopulmonary bypass

You may not qualify if:

  • 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 within \<6 months
  • History of Guillain-Barré syndrome
  • Immunosuppressive disorders or medications (including oral prednisone \>10 mg daily, recent chemotherapy treatment)
  • Emergency cases as determined by the investigator or physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences North Research Institute

Greater Sudbury, Ontario, P3E5J1, Canada

Location

MeSH Terms

Interventions

Influenza VaccinesSodium Chloride

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Roni Atoui, MSc MD FRCSC

    Health Sciences North Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc, MD, FRCSC, Cardiac Surgeon

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

September 1, 2015

Primary Completion

December 25, 2018

Study Completion

December 25, 2018

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

CA(1)