NCT00966342

Brief Summary

This is an invitation to consider taking part in a research study occurring just before the upcoming influenza vaccination program across Canada. The purpose of the study is to closely assess influenza vaccine safety and immune responses, as part of a nationwide, annual surveillance project sponsored by the Public Health Agency of Canada. Such scrutiny is important given the changing nature of flu vaccines from year to year.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

October 23, 2009

Status Verified

October 1, 2009

Enrollment Period

2 months

First QC Date

August 24, 2009

Last Update Submit

October 21, 2009

Conditions

Influenza

Keywords

vaccineinfluenzainfluenza vaccinepandemic preparedness

Outcome Measures

Primary Outcomes (1)

  • Assess the safety and immunogenicity of the licensed Influenza vaccine Fluviral 2009/10 measured at 7 and 21 days for safety and 21 days for immunogenicity

    21 days

Study Arms (1)

Vaccine

OTHER

Everyone gets licensed Influenza vaccine

Drug: Fluviral 2009/10

Interventions

Fluviral 2009/10DRUG

single dose given IM .05 mL

Vaccine

Eligibility Criteria

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

You may qualify if:

  • Good general health
  • Written informed consent
  • Adults 20-64 years of age

You may not qualify if:

  • compromised immune system
  • allergies to eggs or thimerosol
  • life-threatening reaction to previous Flu vaccine
  • chronic illness, bleeding disorder
  • any Flu vaccine within 6 mths planning any other vaccine during study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KFLA Public Health Department

Kingston, Ontario, Canada

Location

Mt Sinai Hospital

Toronto, Ontario, Canada

Location

CHUQ de recherché

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • David Scheifele, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 26, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

October 23, 2009

Record last verified: 2009-10

Locations

CA(3)