Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009

Novartis

Status and phase

Completed

Phase 3

Conditions

Seasonal Influenza, Vaccine

Treatments

Biological: Seasonal Influenza Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735410

V44P12S

2008-000887-18

Details and patient eligibility

About

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
available for all the visits scheduled in the study and able to comply with all study requirements
in good health as determined by: medical history physical examination clinical judgment of the investigator

Exclusion criteria

They Have any serious (in the judgment of the investigator) disease, including but not limited to:

Cancer, except for localized skin cancer Advanced congestive heart failure Chronic obstructive pulmonary disease (COPD) Autoimmune disease (including rheumatoid arthritis) Acute or progressive hepatic disease Acute or progressive renal disease Severe neurological or psychiatric disorder Severe Asthma

They have a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; Receipt of immunostimulants, Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, Suspected or known HIV infection or HIV-related disease.

Known or suspected history of drug or alcohol abuse.
They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
Within the past 4 weeks they have received:

another vaccine any investigational agent;

Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days
Simultaneous participation in another clinical study.
Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
Severely obese with Body Mass Index (BMI) > 35
Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.