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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00306527 |
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Date of registration:
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22/03/2006 |
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Primary sponsor: |
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Public title:
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Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
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Scientific title:
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A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before. |
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Date of first enrolment:
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September 2005 |
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Target sample size:
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2646 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00306527 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Countries of recruitment
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Poland
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Contacts
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Name:
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Novartis Vaccines Drug Information - Services |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Vaccines & Diagnostics |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 18 to < 61 years of age (first age group) OR 61 years of age and older (second age
group) at enrolment in V58P4
2. mentally competent to understand the nature, the scope and the consequences of the
study
3. able and willing to give written informed consent prior to study entry
4. available for all the visits scheduled in the study
5. in good health as determined by:
1. medical history related to the previous six months,
2. physical examination,
3. clinical judgment of the investigator.
Exclusion Criteria:
1. unwilling or unable to give written informed consent to participate in the study
2. currently experiencing an acute infectious disease
3. any serious disease such as, for example:
1. cancer (except for benign or localized skin cancer and non metastatic prostate
cancer not currently treated with chemotherapy),_
2. autoimmune disease (including rheumatoid arthritis),
3. advanced arteriosclerotic disease or complicated diabetes mellitus,
4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
5. acute or progressive hepatic disease,
6. acute or progressive renal disease,
7. congestive heart failure
4. surgery planned during the study period
5. bleeding diathesis
6. history of hypersensitivity to any component of the study medication or chemically
related substances, such as allergy to eggs or egg products
7. known or suspected impairment/alteration of immune function resulting from:
1. receipt of immunosuppressive therapy (any cortical steroid or cancer
chemotherapy),
2. receipt of immunostimulants,
3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
derivatives within the past 3 months and for the full length of the study,
4. high risk for developing an immunocompromising disease
8. history of drug or alcohol abuse
9. laboratory confirmed influenza disease in the past 6 months
10. received influenza vaccine within the past 6 months
11. 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
12. participation in another clinical trial within 90 days prior to enrolment and
throughout the full length of the study
13. 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
14. pregnant/ breast feeding women or women who refuse to use a reliable contraceptive
method during the first three weeks after vaccination
15. any condition which, in the opinion of the investigator, might interfere with the
evaluation of the study objectives.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Biological: Cell culture influenza vaccines
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Biological: egg-derived influenza subunit vaccine
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Primary Outcome(s)
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Immunogenicity
[Time Frame: three weeks after vaccination]
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Safety and tolerability
[Time Frame: up to 3 weeks]
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Secondary Outcome(s)
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SAEs, adverse events necessitating a physician's visit and/or resulting in premature subject's withdrawal from study
[Time Frame: six months after immunization]
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Secondary ID(s)
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EUDRACT: 2005-001902-26
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V58P4E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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