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

November 1, 2019 updated by: Rebecca Cox, University of 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, N5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pandemic influenza H1N1 vaccine
Influenza vaccine
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 Names:
  • Pandemrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7, 14, 21 days post vaccination and long term follow up for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Haukeland University Hospital

Investigators

  • Study Chair: Per Espen Akselsen, MD, Haukeland University Hospital
  • Study Chair: Haakon Sjursen, MD PhD, Haukeland University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (ESTIMATE)

October 28, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H1N1VAC-2009, Version 1
  • 2009-016456-43 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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