A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2010/2011 Formulation of the Enzira® vaccine in Two Groups of Healthy Volunteers: ‘Adults’ (aged 18 to 59 years) and ‘Older Adults’ (aged 60 years or older).

Conditions: Prophylaxis of influenza
MedDRA version: 12.1Level: LLTClassification code 10059429Term: Influenza immunisation

Registration Number: EUCTR2010-019532-12-GB

Lead Sponsor: CSL Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Males or females aged 18 years or older at the time of vaccination.
2.Participants capable of understanding the purposes and risks of the study and are able to provide written informed consent.
3.Willing and able to adhere to all protocol requirements
4.Assessed as being able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress / discomfort.
5.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. Accepted contraceptive precautions include: oral contraception, intrauterine contraceptive device or equivalent hormonal contraception (e.g., progestogen-only implant, vaginal contraceptive ring, transdermal hormonal patch or injectable contraceptives), abstinence, partner vasectomy, acceptable barrier methods used routinely in conjunction with spermicide (either by participant or participant's partner). Females of child-bearing potential must return a negative urine pregnancy test result at Visit 1, prior to vaccination with the 2010/2011 formulation of Enzira® vaccine.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine.
2.Clinical signs of an active infection and/or an elevated oral temperature (38.0°C or higher) at study entry.
3.A clinically significant medical or psychiatric condition, such as:
•For acute conditions (active or recent); the condition required hospitalisation within the last month; or
•For chronic conditions: the Investigator feels that the chronic condition is unstable, such as illness exacerbations within the previous month:
i.requiring hospitalisation;
ii.with significant organ function deterioration;
iii.with major changes to treatment dosages;
iv.requiring major new treatments; or
•The Investigator feels the participant has a clinical condition that may be adversely affected through study participation.
4.A confirmed or suspected immunosuppressive condition (congenital or acquired; including cancer and human immunodeficiency virus infection).
5.History of seizures, with the exception of a past history of a single seizure event at any age that occurred more than 2 years previously.
6.History of Guillain-Barré Syndrome.
7.Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine (e.g. a candidate pandemic influenza virus vaccine or a novel influenza virus vaccine) in the 6 months preceding administration of the Enzira® vaccine. This includes vaccination with the 2009 H1N1 pandemic influenza vaccine in the 6 months preceding administration of the Enzira® vaccine.
8.Currently receiving treatment with radiotherapy or cytotoxic drugs, or has received such treatment within the 6 months preceding administration of the Enzira® vaccine.
9.Currently receiving systemic glucocorticoid therapy (excluding topical, inhaled or intra-articular preparations) or has received such therapy within the 3 months preceding administration of the Enzira® vaccine:
•Chronic or long term corticosteroids: = 15 mg/day of oral prednisolone or equivalent daily;
•Sporadic corticosteroids: = 40 mg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months preceding vaccination;
10.Currently receiving immunoglobulins and/or any blood products or has received such treatment within the 3 months preceding the administration of the Enzira® vaccine.
11.Currently participating in another investigational study or recent study participation ending 3 months preceding administration of the Enzira® vaccine.
12.Currently receiving treatment with warfarin or other anticoagulants.
13.Evidence or history of substance or alcohol abuse within the 12 months before administration of the Enzira® vaccine.
14.Females of child bearing potential, who were planning to become pregnant or planning to discontinue contraceptive precautions during the study period.
15.Females who are pregnant or lactating.
16.Any issues that, in the opinion of the Investigator, would render the subject unsuitable for study participation.