Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen (H1N1VAC)

Tracking Information
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; (submitted: September 19, 2016)	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.
Original Primary Outcome Measures ICMJE; (submitted: October 27, 2009)	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; (submitted: September 19, 2016)	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
Original Secondary Outcome Measures ICMJE; (submitted: October 27, 2009)	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: Examine adverse events of all employees after vaccination using adverse events form; Examine the immunogenicity of the vaccine by collecting blood samples at days 0, 21 & 42 after vaccination (up to 500 people); Provide a detailed time course of the immune response to vaccination with a novel influenza H1N1 virus including the kinetics of the T-cell, B-cell and antibody responses in 50 volunteers; Investigate the long lasting immunity induced by the vaccine; Examine the ability of the vaccine to induce cross-reactive immunity to H1N1 strains.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
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
Study Arms	Experimental: Pandemic influenza H1N1 vaccine; Influenza vaccine; Intervention: Biological: Adjuvanted influenza H1N1split virion vaccine
Publications *	Pedersen G, Halstensen A, Sjursen H, Naess A, Kristoffersen EK, Cox RJ. Pandemic influenza vaccination elicits influenza-specific CD4+ Th1-cell responses in hypogammaglobulinaemic patients: four case reports. Scand J Immunol. 2011 Aug;74(2):210-8. doi: 10.1111/j.1365-3083.2011.02561.x.; Pathirana RD, Bredholt G, Akselsen PE, Pedersen GK, Cox RJ. A(H1N1)pdm09 vaccination of health care workers: improved immune responses in low responders following revaccination. J Infect Dis. 2012 Dec 1;206(11):1660-9. doi: 10.1093/infdis/jis589. Epub 2012 Sep 11.; Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nøstbakken JK, Nilsen M, Mohn K, Jul-Larsen A, Smith I, Major D, Wood J, Cox RJ. An adjuvanted pandemic influenza H1N1 vaccine provides early and long term protection in health care workers. Vaccine. 2010 Dec 16;29(2):266-73. doi: 10.1016/j.vaccine.2010.10.038. Epub 2010 Oct 27.; Jul-Larsen Å, Madhun AS, Brokstad KA, Montomoli E, Yusibov V, Cox RJ. The human potential of a recombinant pandemic influenza vaccine produced in tobacco plants. Hum Vaccin Immunother. 2012 May;8(5):653-61. doi: 10.4161/hv.19503. Epub 2012 May 1.; Lartey S, Pathirana RD, Zhou F, Jul-Larsen Å, Montomoli E, Wood J, Cox RJ. Single dose vaccination of the ASO3-adjuvanted A(H1N1)pdm09 monovalent vaccine in health care workers elicits homologous and cross-reactive cellular and humoral responses to H1N1 strains. Hum Vaccin Immunother. 2015;11(7):1654-62. doi: 10.1080/21645515.2015.1048939.; Eidem S, Tete SM, Jul-Larsen Å, Hoschler K, Montomoli E, Brokstad KA, Cox RJ. Persistence and avidity maturation of antibodies to A(H1N1)pdm09 in healthcare workers following repeated annual vaccinations. Vaccine. 2015 Aug 7;33(33):4146-54. doi: 10.1016/j.vaccine.2015.05.081. Epub 2015 Jun 7.; Manenti A, Tete SM, Mohn KG, Jul-Larsen Å, Gianchecchi E, Montomoli E, Brokstad KA, Cox RJ. Comparative analysis of influenza A(H3N2) virus hemagglutinin specific IgG subclass and IgA responses in children and adults after influenza vaccination. Vaccine. 2017 Jan 3;35(1):191-198. doi: 10.1016/j.vaccine.2016.10.024. Epub 2016 Oct 24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 19, 2016)	255
Original Estimated Enrollment ICMJE; (submitted: October 27, 2009)	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: Persons with a history of anaphylaxis or serious reactions to any vaccine; Person with known hypersensitivity to any of the vaccine components; Persons who have had a temperature >38oC during the previous 72 hours; Persons who have had an acute respiratory infection during the last 7 days; Suspected non-compliance
Sex/Gender	Sexes Eligible for Study: All
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 )
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	Study Chair: Per Espen Akselsen, MD Haukeland University Hospital Study Chair: Haakon Sjursen, MD PhD Haukeland University Hospital
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