Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu
| Tracking Information | |||||
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| First Received Date ICMJE | June 30, 2006 | ||||
| Last Updated Date | January 25, 2007 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Safety, tolerability and local reactogenicity-AEs and laboratory parameters. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00347529 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Immunogenicity of the vaccine | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety Study of an Influenza Vaccine Against a Potential Pandemic Strain of Flu | ||||
| Official Title ICMJE | A Randomised Double Blind Dose-Ranging Study to Assess the Safety, Tolerability and Immunogenicity of a Monovalent H5 DNA Influenza Vaccine (A Vietnam/1194/2004) Administered by Particle Mediated Epidermal Delivery (PMED) to Healthy Adults | ||||
| Brief Summary | The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given, any effects it may have on subjects' wellbeing and whether it can produce antibody responses in the body that may protect against the subjects catching a pandemic strain of flu |
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| Detailed Description | Pandemic influenza occurs when a strain of influenza to which the human population has not been exposed develops the ability to infect man and spread from person to person. Some pandemics can have very severe health impacts and be widespread. This study will evaluate PowderMed's Particle Mediated Epidermal Delivery (PMED) DNA vaccine for pandemic influenza as a potential alternative to other vaccine technologies. This study represents the first study with this vaccine and will provisionally assess its safety and immunogenicity (ability to generate an immune response) at four different dose combinations. The vaccine will be given as a prime-boost regimen with vaccination on Days 0 and 28 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Influenza (Pandemic) | ||||
| Intervention ICMJE | Biological: pPML7789 with and without pPJV2012 administered by PMED | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 75 | ||||
| Completion Date | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent - Exclusion Criteria: No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment |
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00347529 | ||||
| Other Study ID Numbers ICMJE | PM FLP-001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | PowderMed | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | PowderMed | ||||
| Verification Date | January 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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