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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
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of 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

Condition or disease Intervention/treatment Phase
Healthy Biological: Adjuvanted influenza H1N1split virion vaccine Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pandemic influenza H1N1 vaccine
Influenza vaccine
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003288


Locations
Norway
Haukeland University Hospital
Bergen, Norway, N5021
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Investigators
Study Chair: Per Espen Akselsen, MD Haukeland University Hospital
Study Chair: Haakon Sjursen, MD PhD Haukeland University Hospital

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rebecca Cox, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT01003288     History of Changes
Other Study ID Numbers: H1N1VAC-2009, Version 1
2009-016456-43 ( EudraCT Number )
First Posted: October 28, 2009    Key Record Dates
Results First Posted: August 24, 2016
Last Update Posted: November 7, 2016
Last Verified: September 2016

Keywords provided by Rebecca Cox, University of Bergen:
H1N1 pandemic vaccine immunogenicity safety
Health employees

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs