NCT01000831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

October 21, 2009

Last Update Submit

April 14, 2015

Conditions

Influenza

Keywords

vaccineinfluenzaH1N1 influenza vaccineinfluenza vaccineArepanrix

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Adjuvanted Arepanrix 2 doses

ACTIVE COMPARATOR

Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart

Biological: adjuvanted Arepanrix

Interventions

adjuvanted ArepanrixBIOLOGICAL

Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Also known as: Influenza vaccine
Adjuvanted Arepanrix 2 doses

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Alberta Children's Hospital, University of Calgary

Calgary, Alberta, Canada

Location

Child and Family Research Institute

Vancouver, British Columbia, Canada

Location

Vaccine Evaluation Center, University of British Columbia

Vancouver, British Columbia, Canada

Location

Canadian Center for Vaccinology, Dalhousie University

Halifax, Nova Scotia, Canada

Location

McGill University Health Center - Vaccine Study Center

Montreal, Quebec, Canada

Location

Unité de Recherche en Santé Publique (CHUQ)

Québec, Quebec, Canada

Location

Related Publications (1)

  • 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.

    PMID: 21178654RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • David Scheifele, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Marc Dionne, MD

    Unité de Recherche en Santé Publique (CHUQ)

    STUDY DIRECTOR

  • Brian Ward, MD

    McGill University Health Center - Vaccine Study Center

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 23, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

CA(6)