MedTrace Logo

Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults With HIV

NCT01002040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-04-15

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 HIV-infected adults. The study will enroll 150 adults (ages 20-59 years). Participants will be randomized into 2 groups and will receive either one dose or two doses of a licensed H1N1 vaccine. Study procedures include: medical history, blood samples and completing a memory aid. Participants will be involved in study related procedures for approximately 6 days.

Conditions

  • HIV Infections
  • H1N1 Influenza

Interventions

BIOLOGICAL

Arepanrix

Group A receives one dose of Arepanrix

BIOLOGICAL

Arepanrix

Group B receives 2 doses of Arepanrix 3 weeks apart

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • GlaxoSmithKline

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David Scheifele, MD · University of British Columbia

  • Curtis Cooper, MD · University of Ottawa / Ottawa Hospital Research Institute,

  • Marina Klein, MD · McGill University

  • Brian Ward, MD · McGill University

  • Sharon Walmsley, MD · University of Toronto

  • Allison McGeer, MD · University of Toronto

  • David Hasse, MD · Dalhousie University

  • Shelly McNeil, MD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31
Completion
2010-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

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 NCT01002040 on ClinicalTrials.gov