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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003288
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : August 24, 2016
Last Update Posted : November 7, 2016
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Healthy
Intervention: Biological: Adjuvanted influenza H1N1split virion vaccine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HCW working at Haukeland University Hospital during the influenza pandemic in 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Pandemic Influenza Vaccine (H1N1)v

Pandemrix: 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)

Participant Flow:   Overall Study
    Pandemic Influenza Vaccine (H1N1)v
STARTED   255 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Health Care Workers Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
Hypogammaglobulinaemic Patients Received two doses of pandemic vaccine
Total Total of all reporting groups

Baseline Measures
   Health Care Workers   Hypogammaglobulinaemic Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 251   4   255 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   251   4   255 
>=65 years   0   0   0 
[Units: Participants]
Female   195   3   198 
Male   56   1   57 
Region of Enrollment 
[Units: Participants]
Norway   251   4   255 

  Outcome Measures

1.  Primary:   Number of Participants With Local and Systemic Adverse Events   [ Time Frame: 21 days after vaccination ]

2.  Secondary:   Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay   [ Time Frame: 7, 14, 21 days post vaccination and long term follow up for 5 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Professor Rebecca Cox
Organization: University of Bergen
phone: +4755974668

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Rebecca Cox, University of Bergen Identifier: NCT01003288     History of Changes
Other Study ID Numbers: H1N1VAC-2009, Version 1
2009-016456-43 ( EudraCT Number )
First Submitted: October 27, 2009
First Posted: October 28, 2009
Results First Submitted: June 6, 2015
Results First Posted: August 24, 2016
Last Update Posted: November 7, 2016