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Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
adjuvanted Arepanrix
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring vaccine, influenza, H1N1 influenza vaccine, influenza vaccine, Arepanrix

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Adjuvanted Arepanrix 2 doses

Arm Description

Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
October 21, 2009
Last Updated
April 14, 2015
Sponsor
University of British Columbia
Collaborators
Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT01000831
Brief Title
Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children
Official Title
PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children
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
Name of the Sponsor
University of British Columbia
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 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.
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: To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvanted Arepanrix 2 doses
Arm Type
Active Comparator
Arm Description
Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart
Intervention Type
Biological
Intervention Name(s)
adjuvanted Arepanrix
Other Intervention Name(s)
Influenza vaccine
Intervention Description
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Primary Outcome Measure Information:
Title
Safety and immunogenicity of one and two doses Arepanrix
Description
To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age
Time Frame
Day 7 and Day 21 post vaccination measured at day 42
Title
Rapid Trial
Description
To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible
Time Frame
Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
Marc Dionne, MD
Organizational Affiliation
Unité de Recherche en Santé Publique (CHUQ)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Brian Ward, MD
Organizational Affiliation
McGill University Health Center - Vaccine Study Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne Langley, MD
Organizational Affiliation
Canadian Center for Vaccinology, Dalhousie University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Otto Vanderkooi, MD
Organizational Affiliation
Alberta Children's Hospital, University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Simon Dobson, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
Alberta Children's Hospital, University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Child and Family Research Institute
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
Canadian Center for Vaccinology, Dalhousie University
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
McGill University Health Center - Vaccine Study Center
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Unité de Recherche en Santé Publique (CHUQ)
City
Quebec City
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21178654
Citation
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.
Results Reference
result
Links:
URL
http://pcirn.ca/
Description
click on publications and research to view Clinical Trials network activities

Learn more about this trial

Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

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