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

Primary Purpose

H1N1/2009 Influenza

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Arepanrix
Arepanrix
Sponsored by
David Scheifele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for H1N1/2009 Influenza focused on measuring vaccine, H1N1, influenza, H1N1 influenza vaccine, pandemic

Eligibility Criteria

6 Months - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Calgary Health Services and Alberta Children's Hospital
  • Capital Health District, Alberta Health Services
  • Child and Family Research Center
  • Vaccine Evaluation Center, University of British Columbia
  • University of Manitoba Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Adults: One doses of H1N12009 vaccine

Children: Two doses of H1N12009 vaccine given 3 weeks apart

Outcomes

Primary Outcome Measures

Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination

Secondary Outcome Measures

Comparison of baseline and post-immunization antibody titres

Full Information

First Posted
October 21, 2009
Last Updated
April 8, 2015
Sponsor
David Scheifele
Collaborators
Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01001026
Brief Title
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults
Official Title
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David Scheifele
Collaborators
Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H1N1/2009 Influenza
Keywords
vaccine, H1N1, influenza, H1N1 influenza vaccine, pandemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Adults: One doses of H1N12009 vaccine
Arm Title
2
Arm Type
Other
Arm Description
Children: Two doses of H1N12009 vaccine given 3 weeks apart
Intervention Type
Biological
Intervention Name(s)
Arepanrix
Intervention Description
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
Intervention Type
Biological
Intervention Name(s)
Arepanrix
Intervention Description
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart
Primary Outcome Measure Information:
Title
Occurrence of adverse events (AEs) for days 0-6 after each vaccination
Time Frame
Day 7 and Day 21 post vaccination
Title
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 Measure Information:
Title
Comparison of baseline and post-immunization antibody titres
Time Frame
Day 21 (adults) and Day 42 (children)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Scheifele, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ethan Rubinstein, MD
Organizational Affiliation
University of Manitoba Health Sciences Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gerald Predy, MD
Organizational Affiliation
Alberta Health Services, Edmonton
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Laura Sauve, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Calgary Health Services and Alberta Children's Hospital
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Capital Health District, Alberta Health Services
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Child and Family Research Center
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Vaccine Evaluation Center, University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
University of Manitoba Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21788422
Citation
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.
Results Reference
derived

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

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