Healthy
Conditions
Keywords
H1N1 pandemic vaccine immunogenicity safety, Health employees
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.
Interventions
BIOLOGICALAdjuvanted 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)
Sponsors
Haukeland University Hospital
University of Bergen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Norway
Participant flow
Recruitment details
HCW working at Haukeland University Hospital during the influenza pandemic in 2009
Participants by arm
| Arm | Count |
|---|---|
| Health Care Workers Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional | 251 |
| Hypogammaglobulinaemic Patients Received two doses of pandemic vaccine | 4 |
| Total | 255 |
Baseline characteristics
| Characteristic | Health Care Workers | Hypogammaglobulinaemic Patients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 251 Participants | 4 Participants | 255 Participants |
| Region of Enrollment Norway | 251 participants | 4 participants | 255 participants |
| Sex: Female, Male Female | 195 Participants | 3 Participants | 198 Participants |
| Sex: Female, Male Male | 56 Participants | 1 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 196 / 255 |
| serious Total, serious adverse events | 0 / 255 |
Outcome results
Primary
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
Population: solicited adverse event forms were collected from the volunteers
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemic Vaccine | Number of Participants With Local and Systemic Adverse Events | 207 participants |
Secondary
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
Population: Only HCW 251 were assessed for HI antibodies at 21 days post vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemic Vaccine | Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay | 251 participants |