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

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ClinicalTrials.gov Identifier: NCT01003288
Recruitment Status : Completed
First Posted : October 28, 2009
Results First Posted : August 24, 2016
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
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
Enrollment 255
Recruitment Details HCW working at Haukeland University Hospital during the influenza pandemic in 2009
Pre-assignment Details  
Arm/Group Title Pandemic Influenza Vaccine (H1N1)v
Hide Arm/Group Description

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)

Period Title: Overall Study
Started 255
Completed 255
Not Completed 0
Arm/Group Title Health Care Workers Hypogammaglobulinaemic Patients Total
Hide Arm/Group Description Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional Received two doses of pandemic vaccine Total of all reporting groups
Overall Number of Baseline Participants 251 4 255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 4 participants 255 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
251
 100.0%
4
 100.0%
255
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 251 participants 4 participants 255 participants
Female
195
  77.7%
3
  75.0%
198
  77.6%
Male
56
  22.3%
1
  25.0%
57
  22.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 251 participants 4 participants 255 participants
251 4 255
1.Primary Outcome
Title Number of Participants With Local and Systemic Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
solicited adverse event forms were collected from the volunteers
Arm/Group Title Pandemic Vaccine
Hide Arm/Group Description:
Pandemic Vaccine in HCW
Overall Number of Participants Analyzed 255
Measure Type: Number
Unit of Measure: participants
207
2.Secondary Outcome
Title Number of Participants With Immunogenicity as Determined Using Haemagglutination Inhibition Assay
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only HCW 251 were assessed for HI antibodies at 21 days post vaccination
Arm/Group Title HCW Pandemic Vaccine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 251
Measure Type: Number
Unit of Measure: participants
251
Time Frame 5 year follow up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pandemic Vaccine
Hide Arm/Group Description HCW vaccinated with pandemic vaccine
All-Cause Mortality
Pandemic Vaccine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pandemic Vaccine
Affected / at Risk (%) # Events
Total   0/255 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pandemic Vaccine
Affected / at Risk (%) # Events
Total   196/255 (76.86%)    
Infections and infestations   
pain at injection site *  196/255 (76.86%)  196
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Rebecca Cox
Organization: University of Bergen
Phone: +4755974668
EMail: rebecca.cox@uib.no
Publications of Results:
Layout table for additonal information
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 )
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 18, 2019