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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: |
NCT00996138 |
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Date of registration:
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15/10/2009 |
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Primary sponsor: |
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Public title:
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Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
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Scientific title:
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A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00996138 |
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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: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Countries of recruitment
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Japan
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy Japanese adults aged 20 to 60 years
Exclusion Criteria:
- History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral
proteins or excipients
- Administration of adjuvanted influenza vaccine or suspected influenza disease within
3 month prior to study start
- Administration of any other vaccines within 4 weeks prior to enrollment expect for
seasonal influenza vaccines within 1 week
- History of progressive or severe neurological disorders
Age minimum:
29 Years
Age maximum:
60 Years
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: Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine
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Primary Outcome(s)
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Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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AEs, vital signs, laboratory tests
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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