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Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine

NCT01000584 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 309

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 adults when given at the same time or prior to the seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine and one dose of the seasonal influenza vaccine at the same time; the second group will receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009 influenza vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 3-6 weeks depending upon the group assignment.

Conditions

Interventions

BIOLOGICAL

Arepanrix, Vaxigrip 2009/2010

Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently

BIOLOGICAL

Arepanrix, Vaxigrip 2009/2010

Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • David Scheifele

    lead OTHER

Principal Investigators

  • David Scheifele, MD · University of British Columbia

  • Allison McGeer, MD · University of Toronto, Mt Sinai Hospital

  • Mark Loeb, MD · McMaster University

  • Ian Gemmill, MD · Kingston, Frontenac, Lanark Health Unit

  • Marc Dionne, MD · Institut national de sante publique du Quebec

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
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

More Related Trials

Entities

Diseases

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 NCT01000584 on ClinicalTrials.gov