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 aged greater than or equal to 6 months to less than 18 years.

Conditions: Influenza, human
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-003768-19-Outside-EU/EEA

Lead Sponsor: CSL Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 1350

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.)
Are the trial subjects under 18? yes
Number of subjects for this age range: 1350
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that vaccination with CSL Limited’s Influenza Virus Vaccine (CSL’s IVV) elicits an immune response that is not inferior to that of a US licensed inactivated split-virion influenza vaccine (Fluzone®) in a pediatric population aged 6 months to less than 18 years. ;Secondary Objective: To assess the safety and tolerability of CSL’s IVV in a pediatric population aged 6 months to less than 18 years.;Primary end point(s): Geometric Mean Titer 30 days after the last study vaccination.<br>Percentage of subjects with seroconversion 30 days after the last study vaccination.;Timepoint(s) of evaluation of this end point: 30 days after the last study vaccination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency and intensity of local and systemic solicited symptoms in each age cohort: children 6 months to <less than 3 Years, 3 years to less than 9 years and 9 years to less than 18 years.<br>Frequency and intensity of Unsolicited Adverse Events (UAEs)<br>The frequency of Serious Adverse Events (AEs) and New Onset of Chronic Illnesses (NOCIs) for 6 months following vaccination in each age cohort.;Timepoint(s) of evaluation of this end point: For local and systemic solicited symptoms : 7 days after each vaccination.<br>For Unsolicited Adverse Events (UAEs) : 30 days after each vaccination.<br>For Serious Adverse Events (AEs) and New Onset of Chronic Illnesses (NOCIs) : 6 months after last study vaccination.