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AzTrials

HealthyH1N1VACNCT01003288

Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

A study testing Adjuvanted influenza H1N1split virion vaccine in people with Healthy, run by University of Bergen at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Adjuvanted influenza H1N1split virion vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteNorway
Study dates
Oct 2009to Dec 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Haukeland University Hospital

    Bergen, N5021

Other trials in Norway

About this study

Official title: Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

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

Read the 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.
Conditions
Healthy
Being tested
Adjuvanted influenza H1N1split virion vaccine
Keywords
H1N1 pandemic vaccine immunogenicity safety, Health employees

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjuvanted influenza H1N1split virion vaccineBiological

    Also called 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)
Study groups in NCT01003288
Study groupRoleWhat they receive
Pandemic influenza H1N1 vaccineExperimentalInfluenza vaccine
Receives: Biological: Adjuvanted influenza H1N1split virion vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 21 days after vaccination

Secondary outcomes (1)

  1. 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

    Measured: 7, 14, 21 days post vaccination and long term follow up for 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJan 2010
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003288
Sponsor's protocol ID
H1N1VAC-2009, Version 1
Other IDs
2009-016456-43, 2009
Acronym
H1N1VAC
Status last verified
Nov 2019
First submitted
27 Oct 2009
Last updated
18 Nov 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 21034828

  • 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.

    PubMed 21438900

  • 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.

    PubMed 22634440

  • 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.

    PubMed 22969149

  • 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.

    PubMed 26009966

  • 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.

    PubMed 26057137

  • 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.

    PubMed 30131880

  • 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.

    PubMed 28007925

  • 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.

    PubMed 29893797

  • 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.

    PubMed 34938285

  • 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.

    PubMed 27789145

Questions about this trial

What is this clinical trial studying?

A study testing Adjuvanted influenza H1N1split virion vaccine in people with Healthy, run by University of Bergen at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Local and Systemic Adverse Events (time frame: 21 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01003288, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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