A study to determine the safety profile of CSL Limited's 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: EUCTR2014-004131-40-Outside-EU/EEA

Lead Sponsor: CSL Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 2025

Inclusion Criteria

Healthy children were eligible for enrollment if they were aged 6 months to less than 18 years and were born at or after 36 weeks gestation (this criterion applied only to participants aged younger than 9 years) or returned a negative pregnancy test (this criterion applied only to female participants aged 9 years or older).
Are the trial subjects under 18? yes
Number of subjects for this age range: 2025
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

An allergy to any vaccine components; evidence of an active infection; receipt of an experimental or seasonal influenza vaccine in the previous 6 months; a confirmed or suspected immunosuppressive condition; a history of Guillain-Barré Syndrome; a major congenital defect or serious illness; a history of neurologic disorders or seizures; administration of immunoglobulins or any blood products; participation in a clinical study or use of an investigational compound; immunosuppressive or immunomodulatory medication, including systemic corticosteroids; and treatment with cytotoxic drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and tolerability of CSL Limited’s Influenza Virus Vaccine (CSL’s IVV) in a pediatric population aged 6 months to less than 18 years.;Secondary Objective: Not applicable;Primary end point(s): Frequency, severity and duration of local and systemic Solicited adverse events (AEs) for 6 days (total 7 days) following any study vaccination in each age cohort.<br>Frequency, severity and duration of Unsolicited AEs for 29 days (total 30 days) following any study vaccination in each age cohort.<br>Frequency, severity and duration of Serious adverse events (SAEs) and New onset of chronic illness (NOCI) for 180 days following any study vaccination in each age cohort.;Timepoint(s) of evaluation of this end point: 7, 30, 180 days after any study vaccination.

Secondary Outcome Measures