A Study of the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine Administered Intramuscularly in Healthy Adults - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00562484

Purpose

This study will assess the Efficacy, Safety and Tolerability 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.

Condition	Intervention	Phase
Influenza	Biological: CSL Limited Influenza Vaccine Biological: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by CSL Limited:

Primary Outcome Measures:

Incidence of Laboratory Confirmed Influenza A/B infection [ Time Frame: Timeframe: until 30 November 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of Influenza Like Illness, Immune response, Safety [ Time Frame: Incidence of Influenza Like Illness (until 30 November 2008), Immune response (21 days); Safety (approximately 7 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	7500
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: CSL Limited Influenza Vaccine A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
2	Biological: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562484

Contacts

Contact: Peter Richmond, Dr

61 8 9340 7037

Locations

Australia, Australian Capital Territory
The Clinical Trials Unit, Canberra Hospital	Completed
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead	Completed
Westmead, New South Wales, Australia
Eastern Area Health Service, Prince of Wales Hospital	Completed
Randwick, New South Wales, Australia
Australian Clinical Research Organisation	Recruiting
Caringbah, New South Wales, Australia
Contact: Miranda Howells +61 2 9531 4877
Principal Investigator: Alan Saunders, Dr
Australian Clinical Research Organisation	Recruiting
Brookvale, New South Wales, Australia
Contact: Ann Taylor +61 2 9034 1280
Principal Investigator: Charlie Edwards, Dr
Australia, Queensland
Australian Clinical Research Organisation	Recruiting
Kippa Ring, Queensland, Australia
Contact: Jeff Karrasch, Dr +61 7 3889 5019
Principal Investigator: Jeff Karrasch, Dr
Gold Coast Hospital	Completed
Gold Coast, Queensland, Australia
School of Medicine, James Cook University, Cairns Base Hospital	Recruiting
Cairns, Queensland, Australia
Contact: Karen Cooke, Professor +61 7 4050 6530
Principal Investigator: John McBride, Professor
Trialworks Clinical Research Services	Recruiting
Brisbane, Queensland, Australia
Contact: Carol Bendall +61 7 32785255
Principal Investigator: Fred DeLooze, Dr
Australia, South Australia
Paediatric Trials Unit, Women's and Children's Hospital	Completed
Adelaide, South Australia, Australia
CMAX, a division of IDT Australia	Recruiting
Adelaide, South Australia, Australia
Contact: Kate Beard +61 8 8416 3118
Principal Investigator: Sepehr Shakib, Dr
Primary Old Port Road Medical and Dental Centre	Recruiting
Royal Park, South Australia, Australia, 5014
Contact: Richard Watts, Dr +61 8 8239 1113
Principal Investigator: Richard Watts, Dr
ACRO c/o Primary Old Port Rd Medical and Dental Centre	Recruiting
Royal Park, South Australia, Australia
Contact: Ashley Chippett +61 8 8447 0040
Principal Investigator: Richard Watts
Australia, Tasmania
Sexual Health Service	Completed
Hobart, Tasmania, Australia
Australia, Victoria
Murdoch Childrens Research Institute	Completed
Melbourne, Victoria, Australia
Barwon Health, Geelong Hospital	Completed
Geelong, Victoria, Australia
Emeritus Research	Recruiting
Malvern East, Victoria, Australia
Contact: Sarah Bastone +61 3 9509 6166
Principal Investigator: Stephen Hall, Assoc Prof
Australia, Western Australia
Princess Margaret Hospital for Children	Recruiting
Perth, Western Australia, Australia
Contact: Peter Richmond, Dr +61 8 9340 7037
Principal Investigator: Peter Richmond, Dr
Lung Institute of Western Australia	Not yet recruiting
Perth, Western Australia, Australia
Contact: Michelle Davies +61 8 9346 3198
Principal Investigator: Philip Thompson, Prof
New Zealand
Auckland Clinical Studies	Recruiting
Auckland, New Zealand
Contact: Rod Ellis-Pegler, Dr +64 9 373 3474
Principal Investigator: Rod Ellis Pegler, Dr
198 Youth Health Centre	Completed
Christchurch, New Zealand
Christchurch South Health Centre	Recruiting
Christchurch, New Zealand
Contact: Simon Carson, Dr +64 3 332 0108
Principal Investigator: Simon Carson, Dr
Caversham Medical Centre	Recruiting
Dunedin, New Zealand
Contact: Jim Reid, Professor +64 3 479 7430
Principal Investigator: Jim Reid, Professor

Sponsors and Collaborators

CSL Limited

Investigators

Principal Investigator:

Peter Richmond, Dr

Princess Margaret Hospital for Children

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-USF-06-28
Study First Received:	November 20, 2007
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00562484 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe; United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009