Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009
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ClinicalTrials.gov Identifier: NCT00748813 |
Recruitment Status
:
Completed
First Posted
: September 9, 2008
Last Update Posted
: December 1, 2016
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Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Tracking Information | ||||
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First Submitted Date ICMJE | September 8, 2008 | |||
First Posted Date ICMJE | September 9, 2008 | |||
Last Update Posted Date | December 1, 2016 | |||
Study Start Date ICMJE | June 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 [ Time Frame: 21 days (-1/+5) ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00748813 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Evaluation of safety [ Time Frame: 21 days (-1/+5) ] | |||
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 and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009 | |||
Official Title ICMJE | A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub | |||
Brief Summary | Annual trial for registration influenza vaccine with the strain composition for season 2008/2009 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Seasonal Influenza | |||
Intervention ICMJE | Biological: Influenza Vaccine, Formulation 2008-2009
1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009 |
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Study Arms | 1
Intervention: Biological: Influenza Vaccine, Formulation 2008-2009 |
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Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
133 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | July 2008 | |||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Italy | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00748813 | |||
Other Study ID Numbers ICMJE | V71P7S 2008-001079-31 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Vaccines ) | |||
Study Sponsor ICMJE | Novartis Vaccines | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | December 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |