Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen (H1N1VAC)
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ClinicalTrials.gov Identifier: NCT01003288 |
Recruitment Status
:
Completed
First Posted
: October 28, 2009
Results First Posted
: August 24, 2016
Last Update Posted
: November 7, 2016
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 27, 2009 | ||||||
First Posted Date ICMJE | October 28, 2009 | ||||||
Results First Submitted Date | June 6, 2015 | ||||||
Results First Posted Date | August 24, 2016 | ||||||
Last Update Posted Date | November 7, 2016 | ||||||
Study Start Date ICMJE | October 2009 | ||||||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Local and Systemic Adverse Events [ Time Frame: 21 days after vaccination ] Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.
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Original Primary Outcome Measures ICMJE |
The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered adjuvanted H1N1 influenza vaccine in all volunteers [ Time Frame: 2010 ] | ||||||
Change History | Complete list of historical versions of study NCT01003288 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay [ Time Frame: 7, 14, 21 days post vaccination and long term follow up for 5 years ] Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response
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Original Secondary Outcome Measures ICMJE |
The secondary endpoints are the evaluation of the immunogenicity of adjuvanted H1N1 influenza vaccine and the ability of the vaccine to meet the CHMP evaluation criteria in a subset of volunteers [ Time Frame: 2011 ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen | ||||||
Official Title ICMJE | Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen | ||||||
Brief Summary | Haukeland University Hospital has approximately 8000 employees many of whom will be in the front line to receive the pandemic A/H1N1 vaccine. We propose to conduct a safety and immunogenicity study in these subjects | ||||||
Detailed Description | The investigators will conduct a safety and immunogenicity study in health employees as detailed below:
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Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Healthy | ||||||
Intervention ICMJE | Biological: Adjuvanted influenza H1N1split virion vaccine
Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A) * Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) Other Name: Pandemrix |
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Study Arms | Experimental: Pandemic influenza H1N1 vaccine
Influenza vaccine
Intervention: Biological: Adjuvanted influenza H1N1split virion vaccine |
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Publications * |
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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 | ||||||
Actual Enrollment ICMJE |
255 | ||||||
Original Estimated Enrollment ICMJE |
8000 | ||||||
Actual Study Completion Date | December 2014 | ||||||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits for the kinetic study Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years to 70 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Norway | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01003288 | ||||||
Other Study ID Numbers ICMJE | H1N1VAC-2009, Version 1 2009-016456-43 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Rebecca Cox, University of Bergen | ||||||
Study Sponsor ICMJE | University of Bergen | ||||||
Collaborators ICMJE | Haukeland University Hospital | ||||||
Investigators ICMJE |
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PRS Account | University of Bergen | ||||||
Verification Date | September 2016 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |