Status:
COMPLETED
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-...
Eligibility Criteria
Inclusion
- 18 to \<61 years of age
- 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
- in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator.
Exclusion
- unwilling or unable to give written informed consent to participate in the study
- participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
- currently experiencing an acute infectious disease
- any serious disease, such as, for example:
- cancer,
- 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
- history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
- known or suspected impairment/alteration of immune function, for example resulting from:
- receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
- high risk for developing an immunocompromising disease
- history of drug or alcohol abuse
- laboratory-confirmed influenza disease within 6 months prior to Visit 1
- receipt of influenza vaccine within 6 months prior to Visit 1
- receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
- any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
- if female, pregnant or breastfeeding
- if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
- planned relocation abroad during the study period
- any condition that, 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 :
1200 Patients enrolled
Trial Details
Trial ID
NCT00310804
Start Date
September 1 2005
End Date
April 1 2006
Last Update
August 15 2019
Active Locations (2)
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1
2nd Department of Internal Diseases, Panevezys Hospital,
Panevezys, Lithuania
2
Dept. Infectious Diseases and Microbiology of Vilnius University
Vilnius, Lithuania