A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

Study Overview
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Brief Summary
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The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Official Title
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A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

Conditions
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Influenza

Intervention / Treatment
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* Biological: CSL's Influenza Virus Vaccine (Afluria)
* Biological: Influenza Virus Vaccine (Fluzone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination. For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks). Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afluria Cohort A<br>Age 6 months to < 3 years | Biological: CSL's Influenza Virus Vaccine (Afluria)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|
| Experimental: Afluria Cohort B<br>Age 3 to < 9 years | Biological: CSL's Influenza Virus Vaccine (Afluria)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|
| Experimental: Afluria Cohort C<br>Age 9 to < 18 years | Biological: CSL's Influenza Virus Vaccine (Afluria)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|
| Active Comparator: Fluzone Cohort A<br>Age 6 months to < 3 years | Biological: Influenza Virus Vaccine (Fluzone)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|
| Active Comparator: Fluzone Cohort B<br>Age 3 to < 9 years | Biological: Influenza Virus Vaccine (Fluzone)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|
| Active Comparator: Fluzone Cohort C<br>Age 9 to < 18 years | Biological: Influenza Virus Vaccine (Fluzone)<br>* 0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer 30 Days After the Last Study Vaccination |  | 30 days after the last study vaccination | 
| Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination | Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination. | 30 days after the last study vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |  | 7 days after each vaccination | 
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B |  | 7 days after each vaccination | 
| Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C |  | 7 days after vaccination | 
| Frequency and Intensity of Unsolicited Adverse Events (UAEs) | UAE stands for Unsolicited Adverse Events | 30 days after each vaccination | 
| New Onset of Chronic Illnesses (NOCIs) | New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma). | 6 months after last study vaccination | 
| Serious Adverse Events (SAEs) |  | 6 months after last study vaccination | 
| Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years) |  | 7 days after each vaccination | 
| Duration of Local and Systemic Solicited Symptoms, Cohort B |  | 7 days after each vaccination | 
| Duration of Local and Systemic Solicited Symptoms, Cohort C |  | 7 days after vaccination |