Influenza

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

NCT00562484 | PHASE 4 | INTERVENTIONAL

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.

24 Sites

7500 Participants

COMPLETED

18 Years to 64 Years

If interested, contact clinicaltrials@cslbehring.com or +1 610-878-4697 for more information

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Find closest sites:

SUBMIT

The Clinical Trials Unit, Canberra Hospital

Canberra,Australian Capital Territory,Australia

Australian Clinical Research Organisation

Brookvale,New South Wales,Australia

Australian Clinical Research Organisation

Caringbah,New South Wales,Australia

Eastern Area Health Service, Prince of Wales Hospital

Randwick,New South Wales,Australia

National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead

Westmead,New South Wales,Australia

Australian Clinical Research Organisation

Auchenflower,Queensland,Australia,4066

Trialworks Clinical Research Services

Brisbane,Queensland,Australia,4066

Australian Clinical Research Organisation Caboolture Clinical Research Centre

Caboolture,Queensland,Australia,4510

School of Medicine, James Cook University, Cairns Base Hospital

Cairns,Queensland,Australia,4510

Gold Coast Hospital

Gold Coast,Queensland,Australia,4510

Australian Clinical Research Organisation

Kippa Ring,Queensland,Australia,4510

CMAX, a division of IDT Australia

Adelaide,South Australia,Australia,4510

Paediatric Trials Unit, Women's and Children's Hospital

Adelaide,South Australia,Australia,4510

Primary Old Port Road Medical and Dental Centre

Royal Park,South Australia,Australia,5014

Sexual Health Service

Hobart,Tasmania,Australia,5014

Barwon Health, Geelong Hospital

Geelong,Victoria,Australia,5014

Emeritus Research

Malvern East,Victoria,Australia,5014

Murdoch Childrens Research Institute

Melbourne,Victoria,Australia,5014

Lung Institute of Western Australia

Perth,Western Australia,Australia,5014

Princess Margaret Hospital for Children

Perth,Western Australia,Australia,5014

Auckland Clinical Studies

Auckland,Western Australia,New Zealand,5014

Youth Health Centre

Christchurch,Western Australia,New Zealand,5014

Southern Clinical Trials

Christchurch,Western Australia,New Zealand,5014

RMC Medical Centre

Dunedin,Western Australia,New Zealand,5014

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov