Clinical trial NCT01003288: Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Official title: Safety and Immunogenicity Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: H1N1 pandemic vaccine immunogenicity safety
Health employees
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2009-10-28
Enrollment: 255
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay
timeFrame: 7, 14, 21 days post vaccination and long term follow up for 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Per Espen Akselsen, MD
role: STUDY_CHAIR
affiliation: Haukeland University Hospital
name: Haakon Sjursen, MD PhD
role: STUDY_CHAIR
References:
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