Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
NCT ID: NCT01003288
Last Updated: 2019-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
255 participants
INTERVENTIONAL
2009-10-31
2014-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Pandemic influenza H1N1 vaccine
Influenza vaccine
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)
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
19 Years
70 Years
ALL
Yes
Sponsors
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Haukeland University Hospital
OTHER
University of Bergen
OTHER
Responsible Party
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Rebecca Cox
Professor
Principal Investigators
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Per Espen Akselsen, MD
Role: STUDY_CHAIR
Haukeland University Hospital
Haakon Sjursen, MD PhD
Role: STUDY_CHAIR
Haukeland University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Madhun AS, Akselsen PE, Sjursen H, Pedersen G, Svindland S, Nostbakken 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.
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.
Jul-Larsen A, 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.
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.
Lartey S, Pathirana RD, Zhou F, Jul-Larsen A, 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 A, 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.
Trieu MC, Zhou F, Lartey SL, Sridhar S, Mjaaland S, Cox RJ. Augmented CD4+ T-cell and humoral responses after repeated annual influenza vaccination with the same vaccine component A/H1N1pdm09 over 5 years. NPJ Vaccines. 2018 Aug 14;3:37. doi: 10.1038/s41541-018-0069-1. eCollection 2018.
Trieu MC, Zhou F, Lartey S, Jul-Larsen A, Mjaaland S, Sridhar S, Cox RJ. Long-term Maintenance of the Influenza-Specific Cross-Reactive Memory CD4+ T-Cell Responses Following Repeated Annual Influenza Vaccination. J Infect Dis. 2017 Mar 1;215(5):740-749. doi: 10.1093/infdis/jiw619.
Trieu MC, Jul-Larsen A, Saevik M, Madsen A, Nostbakken JK, Zhou F, Skrede S, Cox RJ. Antibody Responses to Influenza A/H1N1pdm09 Virus After Pandemic and Seasonal Influenza Vaccination in Healthcare Workers: A 5-Year Follow-up Study. Clin Infect Dis. 2019 Jan 18;68(3):382-392. doi: 10.1093/cid/ciy487.
Amdam H, Madsen A, Zhou F, Bansal A, Trieu MC, Cox RJ. Functional and Binding H1N1pdm09-Specific Antibody Responses in Occasionally and Repeatedly Vaccinated Healthcare Workers: A Five-Year Study (2009-2014). Front Immunol. 2021 Dec 6;12:748281. doi: 10.3389/fimmu.2021.748281. eCollection 2021.
Manenti A, Tete SM, Mohn KG, Jul-Larsen A, 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.
Other Identifiers
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2009-016456-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
H1N1VAC-2009, Version 1
Identifier Type: -
Identifier Source: org_study_id
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