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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00562237 |
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Date of registration:
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20/11/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Vaccine
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Scientific title:
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Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of Two Adjuvant Formulations of an Egg-Derived Pandemic Surface Antigen Influenza Vaccine in Healthy Adults Aged =18 Years and = 49 Years. |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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400 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00562237 |
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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: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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Finland
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Germany
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Contacts
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Name:
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Global Clinical Director Solvay |
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Address:
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Telephone:
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Email:
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Affiliation:
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Solvay Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- being healthy and = 18 and = 49 years of age
- willing and able to give informed consent
Exclusion Criteria:
- having participated in an influenza H5 vaccine trial in the past
- known to be allergic to any constituent of the vaccine
- serious adverse reactions to previous (influenza) vaccination
- currently participating in another clinical trial or having participated in any
clinical trial in the month preceding the start of the study
- using medication that influences the immune system
Age minimum:
18 Years
Age maximum:
49 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy Subjects
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Intervention(s)
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Biological: S205 10ugHA+1250ugAlOH
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Biological: S205 10ugHA+500ugAlOH
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Biological: S205 placebo
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Biological: S205 10ugHA
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Biological: S205 30ugHA+500ugAlOH
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Biological: S205 30ugHA+1250ugAlOH
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Biological: S205 30ugHA
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Primary Outcome(s)
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Hemagglutination inhibition titers
[Time Frame: one year]
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Secondary Outcome(s)
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Anti-HA antibody level kinetics
[Time Frame: one year]
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CHMP criteria
[Time Frame: one year]
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Safety
[Time Frame: one year]
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Virus neutralization
[Time Frame: one year]
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Secondary ID(s)
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2007-000876-17
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S205.1.001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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