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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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 Intervention
Healthy
 Biological: Pandemrix

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8000
Study Start Date: October 2009
Estimated Study Completion Date: December 2016
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pandemic influenza vaccine (H1N1)v 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)

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.
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003288

Contacts
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

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway, N5021
Contact: Per Espen Akselsne, Cand. med     +47 55 97 53 80     per.akselsen@helse-bergen.no    
Principal Investigator: Per Espen Akslesen, cand. med.            
Sub-Investigator: Haakon Sjursen, Dr. med.            
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
  More Information

Publications:

Responsible Party: Rebecca Cox, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT01003288     History of Changes
Other Study ID Numbers: H1N1VAC-2009, Version 1, EUDRACT number 2009-016456-43
Study First Received: October 27, 2009
Last Updated: May 23, 2013
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 13, 2013