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

This study is currently recruiting participants.

Verified June 2012 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: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 27, 2009

Last Updated Date

June 12, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

January 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01003288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: Pandemic influenza vaccine (H1N1)v

Intervention: Biological: Pandemrix

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

Recruiting

Estimated Enrollment ^ICMJE

8000

Estimated Completion Date

December 2013

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

Gender

Both

Ages

19 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01003288

Other Study ID Numbers ^ICMJE

H1N1VAC-2009, Version 1, EUDRACT number 2009-016456-43

Has Data Monitoring Committee

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

Information Provided By

University of Bergen

Verification Date

June 2012

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

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