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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
PHAC/PCIRN Influenza Research Network
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01001026
First received: October 21, 2009
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
H1N1/2009 Influenza
Biological: Arepanrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 (adults) and Day 42 (children) ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Adults: One doses of H1N12009 vaccine
Biological: Arepanrix
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
2
Children: Two doses of H1N12009 vaccine given 3 weeks apart
Biological: Arepanrix
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart

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.
  Eligibility

Ages Eligible for Study:   6 Months to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001026

Locations
Canada, Alberta
Calgary Health Services and Alberta Children's Hospital
Calgary, Alberta, Canada
Capital Health District, Alberta Health Services
Edmonton, Alberta, Canada
Canada, British Columbia
Child and Family Research Center
Vancouver, British Columbia, Canada
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
University of Manitoba Health Sciences Centre
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
PHAC/PCIRN Influenza Research Network
Investigators
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 AHS Cancer Control Alberta
Study Director: Laura Sauve, MD University of British Columbia
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01001026     History of Changes
Other Study ID Numbers: H09-02769
Study First Received: October 21, 2009
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
vaccine
H1N1
influenza
H1N1 influenza vaccine
pandemic

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014