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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01003288
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : August 24, 2016
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen

Tracking Information
First Submitted Date  ICMJE October 27, 2009
First Posted Date  ICMJE October 28, 2009
Results First Submitted Date  ICMJE June 6, 2015
Results First Posted Date  ICMJE August 24, 2016
Last Update Posted Date November 18, 2019
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
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 ]
Change History Complete list of historical versions of study NCT01003288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2016)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Official Title  ICMJE Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in 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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Pandemic influenza H1N1 vaccine
Influenza vaccine
Intervention: Biological: Adjuvanted influenza H1N1split virion vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
255
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2009)
8000
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01003288
Other Study ID Numbers  ICMJE H1N1VAC-2009, Version 1
2009-016456-43 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca Cox, University of Bergen
Study Sponsor  ICMJE University of Bergen
Collaborators  ICMJE Haukeland University Hospital
Investigators  ICMJE
Study Chair: Per Espen Akselsen, MD Haukeland University Hospital
Study Chair: Haakon Sjursen, MD PhD Haukeland University Hospital
PRS Account University of Bergen
Verification Date November 2019

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