Status:
COMPLETED
Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009
Lead Sponsor:
Novartis Vaccines
Conditions:
Seasonal Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Annual trial for registration influenza vaccine with the strain composition for season 2008/2009
Eligibility Criteria
Inclusion
- Subjects eligible for enrollment into this study are male and female adults who are:
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- able to comply with all study requirements
- in good health as determined by:
- medical history
- physical examination
- clinical judgment of the investigator
Exclusion
- They have any serious chronic or acute disease (in the judgment of the investigator) 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 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, kanamycin and neomycin sulphate);
- They have a 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 parenteral or oral corticosteroid 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 derivates within the past 3 months and for the full length of the study;
- suspected or known HIV infection or HIV-related disease;
- They have a known or suspected history of drug or alcohol abuse;
- They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
- Within the past 12 months, they have:
- received more than one injection of influenza vaccine
- Within the past 6 months, they have:
- had laboratory confirmed influenza disease;
- received influenza vaccine;
- Within the past 4 weeks they have received:
- another vaccine;
- any investigational agent;
- They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00748813
Start Date
June 1 2008
End Date
July 1 2008
Last Update
December 1 2016
Active Locations (3)
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1
Site 1
Chieti, Italy, 66100
2
Site 2
Lanciano, Italy, 66034
3
Site 3
Pianiga, Italy, 30034