A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Official Title
-----------------
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population

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

Intervention / Treatment
-----------------
* Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
* Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged >= 6 months to < 9 years at the time of the first study vaccination. For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 9 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br>* Placebo<br>|
| Experimental: CSL425 (7.5 mcg)<br>7.5 mcg of hemagglutinin antigen per dose | Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)<br>* 0.25 mL intramuscular injection on Day 0 and Day 21<br>|
| Experimental: CSL425 (15 mcg)<br>15 mcg of hemagglutinin antigen per dose | Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)<br>* 0.5 mL intramuscular injection on Day 0 and Day 21<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion Rate 21 Days After First Study Vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. | 21 days after the first study vaccination | 
| Seroconversion Rate 21 Days After Second Study Vaccination | Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer. | 21 days after the second study vaccination | 
| Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination |  | 21 days after the first study vaccination | 
| Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination |  | 21 days after the second study vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. | During the 7 days after each study vaccination | 
| Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A |  | During the 7 days after each study vaccination | 
| Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B | Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers. | During the 7 days after each study vaccination | 
| Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B |  | During the 7 days after each study vaccination | 
| Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination | UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities. | During the 21 days after each vaccination | 
| Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs) | A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). | Up to 180 days after the last vaccination |