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

University of Bergen

Status: Completed

Conditions: Healthy

Treatments: Biological: Adjuvanted influenza H1N1split virion vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01003288

H1N1VAC-2009, Version 1

2009-016456-43 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 1 patient group

Pandemic influenza H1N1 vaccine

Experimental group

Description:

Influenza vaccine

Treatment:

Biological: Adjuvanted influenza H1N1split virion vaccine