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Completed

NCT Number: NCT01003288

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

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Key information

Conditions

Healthy

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, N5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjuvanted influenza H1N1split virion vaccine

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Acronym: H1N1VAC

Important dates

Study start
2009
Primary completion
2010
Study completion
2014
First posted
Oct 28, 2009
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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