Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01001026
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : April 10, 2015
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
Information provided by (Responsible Party):
David Scheifele, University of British Columbia

Tracking Information
First Submitted Date  ICMJE October 21, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date April 10, 2015
Study Start Date  ICMJE November 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: 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 [ Time Frame: Day 7 and Day 21 post vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 (adults) and Day 42 (children) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Official Title  ICMJE PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
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).
Detailed Description

During the first wave of the H1N12009 pandemic in Canada, persons of aboriginal background were more often hospitalized with severe infections than were other Canadians. Among First Nations members the hospitalization rate was 5 times higher than the national average. Common risk factors were young age (children and younger adults) and underlying health conditions. A high proportion of aboriginal adults have health conditions that predispose to adverse influenza outcomes, including diabetes, asthma, obesity and smoking-related lung diseases.

Aboriginals could benefit substantially from timely, effective vaccination against pandemic influenza and are expected to be among the first Canadians to be offered vaccine when available. The vaccine dosing recommendation will be based on limited studies in the general population, leaving open the question of whether aboriginals will respond satisfactorily to the recommended dosing. Unique social and biological factors among aboriginals could affect their responses to vaccination, reducing protection or increasing adverse effects. Thus it would be optimal to evaluate the safety and immunogenicity of the pandemic vaccine among the earliest aboriginal recipients, to inform the subsequent vaccination of other aboriginal groups.

The objectives of this study are two-fold:

  1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience sample of children and adults of aboriginal background (First Nations, Metis and Inuit) with emphasis on subgroups at greatest risk of severe disease.
  2. To complete this evaluation soon after the pandemic vaccines become available so as to inform the subsequent use of the vaccines in the aboriginal population.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE H1N1/2009 Influenza
Intervention  ICMJE
  • Biological: Arepanrix
    Adults: One dose Arepanrix vaccine given IM (0.5 mL)
  • Biological: Arepanrix
    Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
Study Arms  ICMJE
  • 1
    Adults: One doses of H1N12009 vaccine
    Intervention: Biological: Arepanrix
  • 2
    Children: Two doses of H1N12009 vaccine given 3 weeks apart
    Intervention: Biological: Arepanrix
Publications * Rubinstein E, Predy G, Sauvé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2014)
156
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
275
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 59 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001026
Other Study ID Numbers  ICMJE H09-02769
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Scheifele, University of British Columbia
Study Sponsor  ICMJE David Scheifele
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • PHAC/CIHR Influenza Research Network
Investigators  ICMJE
Principal Investigator: David Scheifele, MD University of British Columbia
Study Director: 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
PRS Account University of British Columbia
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP