Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01000831
First received: October 21, 2009
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to compare the safety and effectiveness (immune response) to one or two doses of adjuvanted H1N12009 influenza vaccine in young children. An adjuvant is an additive that can boost the immune response. The study will enroll 300 children (ages 6-35 months). Participants will receive 2 doses of adjuvanted H1N12009 vaccine 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 6 weeks.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Safety and immunogenicity of one and two doses Arepanrix [ Time Frame: Day 7 and Day 21 post vaccination measured at day 42 ] [ Designated as safety issue: Yes ]
    To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age

  • Rapid Trial [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible


Biospecimen Retention:   Samples Without DNA

remaining serum to be banked at the PCIRN Bio-Bank in Montreal


Enrollment: 167
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adjuvanted Arepanrix 2 doses
Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart
Biological: adjuvanted Arepanrix
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Other Name: Influenza vaccine

Detailed Description:

The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

  1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.
  2. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.
  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

invited participants from databases within each of the study location jurisdictions

Criteria

Inclusion Criteria:

  • Written informed consent provided for the subject by a parent or legal guardian
  • Children age 6-35 months

Exclusion Criteria:

  • Allergies to eggs, thimerosal, gentamicin sulphate or latex
  • Life-threatening reaction to previous Flu vaccine
  • Bleeding disorder
  • Pregnancy
  • Receipt of blood or blood products in past 3 months
  • Chronic illness that could interfere with trial participation
  • Compromised immune system
  • Previous lab-confirmed H1N12009 infection
  • Receipt of H1N12009 vaccine
  • Receipt of Seasonal Influenza vaccine since March 2009
  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: NCT01000831

Locations
Canada, Alberta
Alberta Children's Hospital, University of Calgary
Calgary, Alberta, Canada
Canada, British Columbia
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia, Canada
Child and Family Research Institute
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Quebec
McGill University Health Center - Vaccine Study Center
Montreal, Quebec, Canada
Unité de Recherche en Santé Publique (CHUQ)
Quebec City, Quebec, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
PHAC/CIHR Influenza Research Network
Investigators
Principal Investigator: David Scheifele, MD University of British Columbia
Study Director: Marc Dionne, MD Unité de Recherche en Santé Publique (CHUQ)
Principal Investigator: Brian Ward, MD McGill University Health Center - Vaccine Study Center
Study Director: Joanne Langley, MD Canadian Center for Vaccinology, Dalhousie University
Study Director: Otto Vanderkooi, MD Alberta Children's Hospital, University of Calgary
Study Director: Simon Dobson, MD University of British Columbia
  More Information

Additional Information:
Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01000831     History of Changes
Other Study ID Numbers: H09-02749
Study First Received: October 21, 2009
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 18, 2014