Studies of Pandemic Influenza (H1N1) 2009 Vaccine in Bergen

University of Bergen255 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

255

Conditions

Healthy

Interventions

Adjuvanted influenza H1N1split virion vaccineBIOLOGICAL

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)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

Number of Participants With Local and Systemic Adverse Events

Solicited adverse events were collected on side reactions form which were filled in for 21 days after pandemic or seasonal vaccination.

Time frame: 21 days after vaccination

Secondary Outcomes

Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay

Antibody responses were measured using the HI assay to evaluate the rapidity and long term duration of the response

Time frame: 7, 14, 21 days post vaccination and long term follow up for 5 years

Data from ClinicalTrials.gov

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