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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016456-43 | EudraCT Number |
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| Name | Class |
|---|---|
| Haukeland University Hospital | OTHER |
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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
The investigators will conduct a safety and immunogenicity study in health employees as detailed below:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pandemic influenza H1N1 vaccine | Experimental | Influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted influenza H1N1split virion vaccine | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Local and Systemic Adverse Events | Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination. | 21 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay | Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response | 7, 14, 21 days post vaccination and long term follow up for 5 years |
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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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| Name | Affiliation | Role |
|---|---|---|
| Per Espen Akselsen, MD | Haukeland University Hospital | Study Chair |
| Haakon Sjursen, MD PhD | Haukeland University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | N5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21034828 | Result | 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. | |
| 21438900 |
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HCW working at Haukeland University Hospital during the influenza pandemic in 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Pandemic Influenza Vaccine (H1N1)v | Pandemrix: 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Care Workers | Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional |
| BG001 | Hypogammaglobulinaemic Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Local and Systemic Adverse Events | Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination. | solicited adverse event forms were collected from the volunteers | Posted | Number | participants | 21 days after vaccination |
|
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5 year follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pandemic Vaccine | HCW vaccinated with pandemic vaccine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain at injection site | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Rebecca Cox | University of Bergen | +4755974668 | rebecca.cox@uib.no |
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| ID | Term |
|---|---|
| C556153 | pandemrix |
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|
| 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. |
| 22634440 | Result | 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. |
| 22969149 | Result | 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. |
| 26009966 | Result | 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. |
| 26057137 | Result | 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. |
| 30131880 | Result | 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. |
| 28007925 | Result | 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. |
| 29893797 | Result | 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. |
| 34938285 | Derived | 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. |
| 27789145 | Derived | 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. |
Received two doses of pandemic vaccine
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay | Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response | Only HCW 251 were assessed for HI antibodies at 21 days post vaccination | Posted | Number | participants | 7, 14, 21 days post vaccination and long term follow up for 5 years |
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| 0 |
| 255 |
| 196 |
| 255 |
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