A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

Seqirus

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Influenza Virus Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00700193

CSLCT-FLU-04-05

Details and patient eligibility

About

The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.

Enrollment

298 patients

Sex

All

Ages

6 months to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months
Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
Be born after a normal gestation period (between 36 and 42 weeks).

Exclusion criteria

Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
Previous influenza vaccination;
Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:

•Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).
Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
Have a known history of Guillain-Barré Syndrome;
Have a major congenital defect or serious illness and
Have a history of neurologic disorders or seizures