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

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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

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).

Condition or disease Intervention/treatment Phase
H1N1/2009 Influenza Biological: Arepanrix Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
Study Start Date : November 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ]
  2. 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 ]

Secondary Outcome Measures :
  1. Comparison of baseline and post-immunization antibody titres [ Time Frame: Day 21 (adults) and Day 42 (children) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
David Scheifele
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR 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 Alberta Health Services, Edmonton
Study Director: Laura Sauve, MD University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Scheifele, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01001026     History of Changes
Other Study ID Numbers: H09-02769
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs