Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Influenza Clinical Trial

Official title:

PCIRN Evaluation of Pandemic H1N12009 Influenza Vaccine After One andTtwo Doses in Young Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000831
• Other study ID #: H09-02749
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2009
• Last updated: April 14, 2015
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• adjuvanted Arepanrix
Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital, University of Calgary	Calgary	Alberta
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)	Quebec City	Quebec
Canada	Child and Family Research Institute	Vancouver	British Columbia
Canada	Vaccine Evaluation Center, University of British Columbia	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR), PHAC/CIHR Influenza Research Network

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 pa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and immunogenicity of one and two doses Arepanrix	To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age	Day 7 and Day 21 post vaccination measured at day 42	Yes
Primary	Rapid Trial	To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible	Day 42	No

External Links

•   click on publications and research to view Clinical Trials network activities