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

October 21, 2009
May 26, 2014
November 2009
February 2010   (final data collection date for primary outcome measure)
  • 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
  • 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 ]
Complete list of historical versions of study NCT01000831 on ClinicalTrials.gov Archive Site
Not Provided
Immunogenicity: Comparison of baseline and post-immunization antibody titres 21 days after each vaccination [ Time Frame: Day 21 post vaccination ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

invited participants from databases within each of the study location jurisdictions

H1N1/2009 Influenza
Biological: adjuvanted Arepanrix
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Other Name: Influenza vaccine
Adjuvanted Arepanrix 2 doses
Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart
Intervention: Biological: adjuvanted Arepanrix
Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
167
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01000831
H09-02749
No
University of British Columbia
University of British Columbia
  • Canadian Institutes of Health Research (CIHR)
  • PHAC/CIHR Influenza Research Network
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
University of British Columbia
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP