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

H1N1/2009 Influenza Clinical Trial

Official title:

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Aboriginal Children and Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001026
• Other study ID #: H09-02769
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2009
• Last updated: April 8, 2015
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 59 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• H1N1/2009 Influenza
• Influenza, Human

Intervention

Biological:
• Arepanrix
Adults: One dose Arepanrix vaccine given IM (0.5 mL)
• Arepanrix
Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart

Locations

Country	Name	City	State
Canada	Calgary Health Services and Alberta Children's Hospital	Calgary	Alberta
Canada	Capital Health District, Alberta Health Services	Edmonton	Alberta
Canada	Child and Family Research Center	Vancouver	British Columbia
Canada	Vaccine Evaluation Center, University of British Columbia	Vancouver	British Columbia
Canada	University of Manitoba Health Sciences Centre	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
David Scheifele	Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events (AEs) for days 0-6 after each vaccination		Day 7 and Day 21 post vaccination	Yes
Primary	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	Yes
Secondary	Comparison of baseline and post-immunization antibody titres		Day 21 (adults) and Day 42 (children)	No