Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

Not Applicable

Completed

Conditions: Healthy

Interventions: Biological: Adjuvanted influenza H1N1split virion vaccine

Registration Number: NCT01003288

Lead Sponsor: University of 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 255

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pandemic influenza H1N1 vaccine	Adjuvanted influenza H1N1split virion vaccine	Influenza vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Local and Systemic Adverse Events	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 Outcome Measures

Name	Time	Method
Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay	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