A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers - Full Text View

Sponsored by:	CSL Limited
Information provided by:	CSL Limited
ClinicalTrials.gov Identifier:	NCT00888381

Purpose

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Condition	Intervention	Phase
Influenza	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)	Phase IV

MedlinePlus related topics: Flu

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment

Further study details as provided by CSL Limited:

Primary Outcome Measures:

Immunogenicity of Enzira® vaccine according to the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. [ Time Frame: 21 ± 4 days after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The frequency of solicited local reactions [ Time Frame: During the 3 days after treatment ] [ Designated as safety issue: Yes ]
The frequency of solicited systemic symptoms [ Time Frame: During the 3 days after treatment ] [ Designated as safety issue: Yes ]
The incidence of unsolicited adverse events [ Time Frame: 21 ± 4 days after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adults: Experimental Healthy volunteers ≥ 18 to < 60 years of age	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation) A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
Older Adults: Experimental Healthy volunteers > or = 60 years of age	Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation) A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Males or females aged ≥ 18 years at the time of providing informed consent
Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
Willing and able to adhere to all protocol requirements
Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
Females of child bearing potential (i.e. ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study

Exclusion Criteria:

Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
A clinically significant medical or psychiatric condition
A confirmed or suspected immunosuppressive condition
History of seizures
History of Guillain-Barré Syndrome
Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
Currently receiving systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry
Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of Enzira® vaccine
Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
Currently receiving treatment with warfarin or other anticoagulants
Evidence or history of substance or alcohol abuse within the 12 months before study entry
Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
Females who are pregnant or lactating
Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888381

Locations

United Kingdom
Chiltern (Early Phase) Limited. Ninewells Hospital and Medical School	Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Karen Harley, Dr +44 1753 619 819 karen.harley@chiltern.com
Principal Investigator: Ronnie Beboso, Dr

Sponsors and Collaborators

CSL Limited

More Information

No publications provided

Responsible Party:	CSL Limited ( Dr Russell Basser )
Study ID Numbers:	CSLCT-NHF-09-57, EUDRACT number: 2009-011450-18
Study First Received:	April 24, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00888381 History of Changes
Health Authority:	European Union: European Medicines Agency

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 May 07, 2009