Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children - Full Text View

Purpose

The purpose of this study is to compare the safety and effectiveness (immune response) to two doses of adjuvanted or non-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 be randomized into 2 groups and will receive 2 doses of adjuvanted or non-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.

Condition	Intervention	Phase
H1N1/2009 Influenza	Biological: Arepanrix	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine in Young Children, Including Randomized Comparison of Adjuvanted and Non-adjuvanted Formulations

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Occurrence of adverse events (AEs) for days 0-6 after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events (SAEs) and other significant health events up to 21 days after each vaccination [ Time Frame: Day 7 and Day 21 post vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity: Comparison of baseline and post-immunization antibody titres 21 days after each vaccination [ Time Frame: Day 21 post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	November 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Group A: Two doses of adjuvanted H1N1 vaccine given 3 weeks apart	Biological: Arepanrix Group A: Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart
Active Comparator: 2 Group B: Two doses of non-adjuvanted H1N1 vaccine given 3 weeks apart	Biological: Arepanrix Group B: Two doses of non-adjuvanted Arepanrix vaccine given 3 weeks apart

Detailed Description:

The goal of this study is to assess the relative advantages and disadvantages of adjuvanted and non-adjuvanted formulations of the H1N12009 influenza vaccine in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

To compare the safety and immunogenicity of 2 doses of adjuvanted or non-adjuvanted H1N12009 influenza vaccine in children 6-35 months of age, in a randomized controlled trial with evaluator (parent) blinding.
To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

Eligibility

Ages Eligible for Study:	6 Months to 35 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000831

Locations

Canada, Alberta
Alberta Children's Hospital, University of Calgary
Calgary, Alberta, Canada
Canada, British Columbia
Vaccine Evaluation Center, University of British Columbia
Vancouver, British Columbia, Canada
Child and Family Research Institute
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada
Canada, Quebec
McGill University Health Center - Vaccine Study Center
Montreal, Quebec, Canada
Unité de Recherche en Santé Publique (CHUQ)
Quebec City, Quebec, Canada

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:	David Scheifele, MD	University of British Columbia
Study Director:	Marc Dionne, MD	Unité de Recherche en Santé Publique (CHUQ)
Principal Investigator:	Brian Ward, MD	McGill University Health Center - Vaccine Study Center
Study Director:	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

More Information

No publications provided

Responsible Party:	Dr. David Scheifele, University of British Columbia
ClinicalTrials.gov Identifier:	NCT01000831 History of Changes
Other Study ID Numbers:	H09-02749
Study First Received:	October 21, 2009
Last Updated:	February 9, 2010
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

vaccine
influenza
H1N1 influenza vaccine
influenza vaccine
Arepanrix

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013