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Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Aboriginal Children and Adults

NCT01001026 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2015-04-10

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and effectiveness (immune response) to a licensed H1N12009 influenza vaccine in aboriginal children and adults. The study will enroll 200 healthy adults (ages 20-59 years) and 75 healthy children (ages 6-35 months). Adults will receive one dose of a licensed H1N1 vaccine and children will receive two doses of a licensed H1N1 vaccine approximately 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 3 weeks (adults) or 6 weeks (children).

Conditions

  • H1N1/2009 Influenza

Interventions

BIOLOGICAL

Arepanrix

Adults: One dose Arepanrix vaccine given IM (0.5 mL)

BIOLOGICAL

Arepanrix

Children: Two doses of Arepanrix vaccine given IM (0.25 mL) three weeks apart

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • PHAC/CIHR Influenza Research Network

    collaborator OTHER_GOV

  • David Scheifele

    lead OTHER

Principal Investigators

  • David Scheifele, MD · University of British Columbia

  • Ethan Rubinstein, MD · University of Manitoba Health Sciences Centre

  • Gerald Predy, MD · Alberta Health Services, Edmonton

  • Laura Sauve, MD · University of British Columbia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001026 on ClinicalTrials.gov