NCT01003288

Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: University of Bergen · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-01-01
• Completion: 2014-12-01
• First posted: 2009-10-28
• Last updated: 2019-11-18
• Results posted: 2016-08-24

Locations

1 site across 1 country: Norway