Status:
COMPLETED
Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
Lead Sponsor:
Novartis Vaccines
Collaborating Sponsors:
Novartis Vaccines and Diagnostics S.r.l.
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryon...
Eligibility Criteria
Inclusion
- 18 to \< 61 years of age (first age group) OR 61 years of age and older (second age group) at enrolment in V58P4
- Mentally competent to understand the nature, the scope and the consequences of the study
- Able and willing to give written informed consent prior to study entry
- Available for all the visits scheduled in the study
- in good health as determined by:
- Medical history related to the previous six months,
- Physical examination,
- Clinical judgment of the investigator.
Exclusion
- Unwilling or unable to give written informed consent to participate in the study
- Currently experiencing an acute infectious disease
- Any serious disease such as, for example:
- Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
- Autoimmune disease (including rheumatoid arthritis)
- Advanced arteriosclerotic disease or complicated diabetes mellitus
- Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
- Acute or progressive hepatic disease
- Acute or progressive renal disease
- Congestive heart failure
- Surgery planned during the study period
- Bleeding diathesis
- History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
- Known or suspected impairment/alteration of immune function resulting from:
- Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
- 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
- High risk for developing an immunocompromising disease
- History of drug or alcohol abuse
- Laboratory confirmed influenza disease in the past 6 months
- Received influenza vaccine within the past 6 months
- Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
- Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
- Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever \_ 38°C within the past 5 days
- Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
2235 Patients enrolled
Trial Details
Trial ID
NCT00306527
Start Date
September 1 2005
End Date
April 1 2006
Last Update
August 14 2019
Active Locations (5)
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1
Wojewódzki Szpital Dzieci_cy
Ul. Langiewicza 2, Kielce, Poland, 25-381
2
Centrum Bada_ Farmakologii Klinicznej
Ul. Ujastek 3, Krakow, Poland, 30-969
3
NZOZ Jagiello_skie
Centrum Medyczne Sp. Z O.o., O_. Jagiello_skie 1, Kraków, Poland, 31-832
4
NZOZ Praktyka Grupowa Lekarzy Rodzinnych, "Familia" Sp. z o.o.
Pl. Sikorskiego 6a, Kraków, Poland, 31-115