A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Seqirus

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: CSL Limited Influenza Vaccine

Biological: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562484

CSLCT-USF-06-28

Details and patient eligibility

About

This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.

Enrollment

7,500 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
Non pregnant/ non lactating females

Exclusion criteria

Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
Vaccination against influenza in the previous 6 months
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
Known history of Guillain-Barré Syndrome;
Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
History of neurological disorders or seizures
Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
Administration of immunoglobulins and/or any blood products;
Participation in a clinical trial or use of an investigational compound;
Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.