Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe.
| Tracking Information | |||||
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| First Received Date ICMJE | June 27, 2006 | ||||
| Last Updated Date | February 5, 2010 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Invivac® 2006/2007 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00345462 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP) | ||||
| 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 | Annual Study to Investigate Inactivated Virosomal Influenza Vaccine for the 2006/2007 Influenza Season in Europe. | ||||
| Official Title ICMJE | Immunogenicity and Reactogenicity of Trivalent Virosomal Influenza Vaccine Invivac® for the Season 2006/2007. An Open, Baseline-controlled Study in Two Groups of Healthy Subjects: Adults and Elderly. | ||||
| Brief Summary | Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available virosomal vaccine (Invivac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Invivac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza virosomal vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Healthy Volunteers | ||||
| Intervention ICMJE | Biological: Trivalent virosomal influenza vaccine | ||||
| 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 | Withdrawn | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00345462 | ||||
| Other Study ID Numbers ICMJE | S206.3.012, 2006-001301-28 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | February 2010 | ||||
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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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