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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: adjuvanted Arepanrix

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.

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Alberta Children's Hospital, University of Calgary
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vaccine Evaluation Center, University of British Columbia
    • Vancouver, British Columbia, Canada
      • Child and Family Research Institute
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Canadian Center for Vaccinology, Dalhousie University
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Center - Vaccine Study Center
    • Quebec City, Quebec, Canada
      • Unité de Recherche en Santé Publique (CHUQ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 Names: Influenza vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and immunogenicity of one and two doses Arepanrix	To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age	Day 7 and Day 21 post vaccination measured at day 42
Rapid Trial	To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible	Day 42

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research Network
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• click on publications and research to view Clinical Trials network activities

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 23, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: vaccine; influenza; influenza vaccine; H1N1 influenza vaccine; Arepanrix
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: H09-02749