Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: adjuvanted Arepanrix

• Registration Number: NCT01000831
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Study Start: 2009-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvanted Arepanrix 2 doses	adjuvanted Arepanrix	Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart

Primary Outcome Measures

Name	Time	Method
Safety and immunogenicity of one and two doses Arepanrix	Day 7 and Day 21 post vaccination measured at day 42	To compare the safety and immunogenicity of one and two doses of adjuvanted H1N12009 pandemic vaccine in children 6-35 months of age
Rapid Trial	Day 42	To conduct this trial soon after the vaccines become available and share observations with health officials and the public as soon as possible

Trial Locations

Locations (6)

Child and Family Research Institute; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Center - Vaccine Study Center; 🇨🇦 Montreal, Quebec, Canada

Alberta Children's Hospital, University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Vaccine Evaluation Center, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Canadian Center for Vaccinology, Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

Unité de Recherche en Santé Publique (CHUQ); 🇨🇦 Quebec City, Quebec, Canada