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

This study has been completed.

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: September 19, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

October 27, 2009

Last Updated Date

September 19, 2016

Start Date ^ICMJE

October 2009

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

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

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

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

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 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

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

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

Enrollment ^ICMJE

255

Completion Date

December 2014

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

Sexes Eligible for Study:

All

Ages

19 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

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

September 2016

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

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