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

Phase 4

Completed

Conditions: Influenza

Interventions: Biological: Inactivated Influenza Vaccine (2009 / 2010 formulation)

Registration Number: NCT00888381

Lead Sponsor: Seqirus

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Older Adults	Inactivated Influenza Vaccine (2009 / 2010 formulation)	Healthy volunteers aged 60 years or older
Adults	Inactivated Influenza Vaccine (2009 / 2010 formulation)	Healthy volunteers aged 18 to 59 years

Primary Outcome Measures

Name	Time	Method
The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.	Approximately 21 days after vaccination	As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of \< 10; significant increase is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.
The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.	Approximately 21 days after vaccination	GMFI is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.
The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.	Approximately 21 days after vaccination

Secondary Outcome Measures

Name	Time	Method
The Frequency of Any Solicited Systemic Symptoms.	During the 4 days after vaccination (Day 0 plus 3 days)	The number of participants reporting any solicited systemic symptoms.
The Frequency of Any Solicited Local Reactions.	During the 4 days after vaccination (Day 0 plus 3 days)	The number of participants reporting any solicited local reactions.
The Incidence of Any Unsolicited Adverse Events (AEs).	After vaccination until the end of the study; approximately 21 days	The number of participants reporting any unsolicited adverse events. Unsolicited adverse event (UAE) grading: Mild: Symptoms were easily tolerated and did not interfere with normal, everyday activities. Moderate: Enough discomfort to have caused some interference with normal, everyday activities. Severe: Symptoms that prevented normal, everyday activities.