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

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Rebecca Cox, University of Bergen
ClinicalTrials.gov Identifier:
NCT01003288
First received: October 27, 2009
Last updated: July 14, 2016
Last verified: July 2016
Results First Received: June 6, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Healthy
Intervention: Biological: Adjuvanted influenza H1N1split virion vaccine

  Participant Flow
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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
  Description
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  
COMPLETED     255  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  251     4     255  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     251     4     255  
>=65 years     0     0     0  
Gender  
[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 and Tolerability of Adjuvanted H1N1 Influenza Vaccine.   [ Time Frame: 21 days after vaccination ]

2.  Secondary:   Evaluation of the Immunogenicity of Adjuvanted H1N1 Influenza Vaccine Using Haemagglutination Inhibition Titres.   [ Time Frame: 7, 14, 21 days post vaccination and long term follow up for 5 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2016   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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
e-mail: rebecca.cox@uib.no


Publications of Results:
Other Publications:

Responsible Party: Rebecca Cox, University of Bergen
ClinicalTrials.gov Identifier: NCT01003288     History of Changes
Other Study ID Numbers: H1N1VAC-2009, Version 1
2009-016456-43 ( EudraCT Number )
Study First Received: October 27, 2009
Results First Received: June 6, 2015
Last Updated: July 14, 2016
Health Authority: Norway: Norwegian Medicines Agency