Influenza Vaccine Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

Healthy adult with 18-65 years of age at the time of the vaccination.

• During the first phase of recruitment (for DSMB review), no female subjects will be

recruited.

• Informed consent must be obtained from the subject prior to beginning any study specific

procedures indicating that they understand the purpose of this study and are willing to

adhere to the procedures described in this protocol.

• Available by phone

Exclusion Criteria

Use of any investigational or non-registered product (drug or vaccine) other than the study

vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use

during the study period.

• Receipt of any other licensed influenza vaccines or investigational influenza vaccine within

6 months prior to enrollment in this study or expected receipt of any vaccination before the

final immune response blood collection.

• History of hypersensitivity to any component of inactivated influenza vaccines.

• Chronic administration (defined as more than 14 days) of immunosuppressant or other

immune-modifying drugs within six months prior to the administration of the study vaccine.

The use of inhaled and nasal steroids will be permitted.

• Any medically diagnosed or suspected immunodeficient condition based on medical history

and physical examination.

• Administration of immunoglobulin and/or any blood products within the three months

preceding the administration of the study vaccine or during the study.

• Acute illness of moderate or severe intensity at the time of enrollment, including any illness

associated with fever >=100.5 0F.

• Any cardiopulmonary disease, including asthma, requiring ongoing medical therapy; known

or suspected abnormal hepatic or renal function, or any congenital abnormalities, including

hemglobinopathies, which could increase the risk of influenza complications.

• History of any neurological disorders or seizures (with the exception of febrile seizures

during childhood) related to an underlying immune disease or disorder, such as but not

limited to: multiple sclerosis, lupus, Guillain-Barre syndrome.

• Any condition that in the opinion of the investigator would interfere with evaluation of the

vaccine or interpretation of study results.

• Females who are found positive in Urinary Pregnancy Test; Pregnant or lactating female,

and; Females planning to become pregnant or planning to discontinue contraceptive

precautions within 60 days of enrollment in this study.

• Volunteers found positive in alcohol breath test and drugs of abuse test

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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