Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

NCT ID: NCT01000831

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 167 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-02-28

Brief 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.

Detailed Description

The goal of this study is to determine if one or two doses of the H1N12009 influenza vaccine are needed in young children, a population group at high risk of influenza infection and subsequent hospitalization.

The objectives of this study are two-fold:

1. To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age.

2. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Adjuvanted Arepanrix 2 doses

Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart

Group Type: ACTIVE_COMPARATOR

adjuvanted Arepanrix

Intervention Type: BIOLOGICAL

Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Interventions

adjuvanted Arepanrix

Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Intervention Type: BIOLOGICAL

Other Intervention Names

Influenza vaccine

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

PHAC/CIHR Influenza Research Network

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Scheifele, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Marc Dionne, MD

Role: STUDY_DIRECTOR

Unité de Recherche en Santé Publique (CHUQ)

Brian Ward, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Center - Vaccine Study Center

Joanne Langley, MD

Role: STUDY_DIRECTOR

Canadian Center for Vaccinology, Dalhousie University

Otto Vanderkooi, MD

Role: STUDY_DIRECTOR

Alberta Children's Hospital, University of Calgary

Simon Dobson, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

Alberta Children's Hospital, University of Calgary

Calgary, Alberta, Canada

Child and Family Research Institute

Vancouver, British Columbia, Canada

Vaccine Evaluation Center, University of British Columbia

Vancouver, British Columbia, Canada

Canadian Center for Vaccinology, Dalhousie University

Halifax, Nova Scotia, Canada

McGill University Health Center - Vaccine Study Center

Montreal, Quebec, Canada

Unité de Recherche en Santé Publique (CHUQ)

Québec, Quebec, Canada

Countries

Canada

References

Scheifele DW, Ward BJ, Dionne M, Vanderkooi O, Langley JM, Dobson S, Li Y, Law B, Halperin SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Rapid Trials Investigators. Evaluation of adjuvanted pandemic H1N1(2009) influenza vaccine after one and two doses in young children. Pediatr Infect Dis J. 2011 May;30(5):402-7. doi: 10.1097/INF.0b013e3182068f33.

Reference Type: RESULT

PMID: 21178654 (View on PubMed)

Other Identifiers

H09-02749

Identifier Type: -

Identifier Source: org_study_id