NCT01001026

Brief Summary

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 3 weeks apart. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3 weeks (adults) or 6 weeks (children).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

October 21, 2009

Last Update Submit

April 8, 2015

Conditions

H1N1/2009 Influenza

Keywords

vaccineH1N1influenzaH1N1 influenza vaccinepandemic

Outcome Measures

Primary Outcomes (2)

  • Occurrence of adverse events (AEs) for days 0-6 after each vaccination

    Day 7 and Day 21 post vaccination

  • Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination

    Day 7 and Day 21 post vaccination

Secondary Outcomes (1)

  • Comparison of baseline and post-immunization antibody titres

    Day 21 (adults) and Day 42 (children)

Study Arms (2)

1

OTHER

Adults: One doses of H1N12009 vaccine

Biological: Arepanrix

2

OTHER

Children: Two doses of H1N12009 vaccine given 3 weeks apart

Biological: Arepanrix

Interventions

ArepanrixBIOLOGICAL

Adults: One dose Arepanrix vaccine given IM (0.5 mL)

1

Eligibility Criteria

Age6 Months - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Good general health
  • Written informed consent provided by or for the subject
  • Aboriginal ethnicity (First Nations, Metis or Inuit)
  • Adults 20-59 years of age
  • Children 6-35 months of age

You may not qualify if:

  • Allergies to eggs, thimerosal or gentamicin sulphate
  • Life-threatening reaction to previous Flu vaccine
  • Bleeding disorder
  • Pregnancy
  • Receipt of blood or blood products in past 3 months
  • Compromised immune system
  • Chronic illness
  • Previous lab-confirmed H1N1/2009 infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Calgary Health Services and Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Capital Health District, Alberta Health Services

Edmonton, Alberta, Canada

Location

Child and Family Research Center

Vancouver, British Columbia, Canada

Location

Vaccine Evaluation Center, University of British Columbia

Vancouver, British Columbia, Canada

Location

University of Manitoba Health Sciences Centre

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

  • Rubinstein E, Predy G, Sauve L, Hammond GW, Aoki F, Sikora C, Li Y, Law B, Halperin S, Scheifele D. The responses of Aboriginal Canadians to adjuvanted pandemic (H1N1) 2009 influenza vaccine. CMAJ. 2011 Sep 20;183(13):E1033-7. doi: 10.1503/cmaj.110196. Epub 2011 Jul 25.

    PMID: 21788422DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

arepanrix

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • David Scheifele, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Ethan Rubinstein, MD

    University of Manitoba Health Sciences Centre

    STUDY DIRECTOR

  • Gerald Predy, MD

    Alberta Health Services, Edmonton

    STUDY DIRECTOR

  • Laura Sauve, MD

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

CA(5)