Rapid Evaluation of Pandemic H1N1 Influenza Vaccines in Young Children

Study Overview
=================
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: To compare the safety and immunogenicity of 1 and 2 doses of adjuvanted H1N12009 influenza vaccine in children 6-35 months of age. To conduct the trial soon after the vaccines become available and share the observations with health officials and the public as soon as possible.

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

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: adjuvanted Arepanrix


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adjuvanted Arepanrix 2 doses<br>Two doses of adjuvanted H1N1 Arepanrix vaccine given 3 weeks apart | Biological: adjuvanted Arepanrix<br>* Two doses of adjuvanted Arepanrix vaccine given 3 weeks apart<br>* Other names: Influenza vaccine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, influenza, H1N1 influenza vaccine, influenza vaccine, Arepanrix