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Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

NCT01000831 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2015-04-15

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

adjuvanted Arepanrix

Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • PHAC/CIHR Influenza Research Network

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David Scheifele, MD · University of British Columbia

  • Marc Dionne, MD · Unité de Recherche en Santé Publique (CHUQ)

  • Brian Ward, MD · McGill University Health Center - Vaccine Study Center

  • Joanne Langley, MD · Canadian Center for Vaccinology, Dalhousie University

  • Otto Vanderkooi, MD · Alberta Children's Hospital, University of Calgary

  • Simon Dobson, MD · University of British Columbia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
35 Months
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 NCT01000831 on ClinicalTrials.gov