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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Bergen
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen
ClinicalTrials.gov Identifier:
NCT01003288
First received: October 27, 2009
Last updated: May 23, 2013
Last verified: May 2013

October 27, 2009
May 23, 2013
October 2009
January 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01003288 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
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

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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Healthy
Biological: 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)

Other Name: Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Experimental: Pandemic influenza vaccine (H1N1)v
Intervention: Biological: Pandemrix

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8000
December 2016
January 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 70 Years
Yes
Contact: . Per Espen Akselsen Akselsen, Can. med. +47 55 97 53 80 per.akselsen@helse-bergen.no
Contact: Marianne Sævik, BSN +47 55 9762 68 marianne.saevik@helse-bergen.no
Norway
 
NCT01003288
H1N1VAC-2009, Version 1, EUDRACT number 2009-016456-43
No
Rebecca Cox, University of Bergen
University of Bergen
Haukeland University Hospital
Study Chair: Per Espen Akselsen, MD Haukeland University Hospital
Study Chair: Haakon Sjursen, MD PhD Haukeland University Hospital
University of Bergen
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP