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Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV

This study has been completed.
Sponsor:
Information provided by:
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT00539864
First received: October 4, 2007
Last updated: July 25, 2011
Last verified: July 2011
Results First Received: May 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: FluBlok Influenza Vaccination
Biological: TIV (Fluzone) Influenza Vaccination

  Participant Flow


  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs)   [ Time Frame: Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization ]

2.  Secondary:   Evaluation and Comparison of Immunogenicity of FluBlok and TIV in Healthy Adults 50-64 Years of Age.   [ Time Frame: Day 0 and Day 28 ]

3.  Secondary:   Percentage of Participants With Seroconversion   [ Time Frame: Day 28 following immunization at Day 0 ]

4.  Secondary:   Percentage of Participants With Seroprotection   [ Time Frame: Day 28 following immunization at Day 0 ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame All AEs - 28 days following immunization; SAEs for duration of influenza season.
Additional Description No text entered.

Reporting Groups
  Description
FluBlok

Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

135μg total

TIV (Fluzone)

Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

45μg total

(Fluzone, sanofi pasteur)


Serious Adverse Events
    FluBlok   TIV (Fluzone)
Total, Serious Adverse Events     
# participants affected / at risk   1/300 (0.33%)   0/302 (0.00%) 
Cardiac disorders     
Vasovagal Syncope * [2]     
# participants affected / at risk   1/300 (0.33%)   0/302 (0.00%) 
# events   1   0 
* Events were collected by non-systematic assessment
[2] Subject experienced a syncopal episode, was treated with intravenous fluids in ER and discharged home without sequelae.




  Other Adverse Events
  Hide Other Adverse Events

Time Frame All AEs - 28 days following immunization; SAEs for duration of influenza season.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   2%  

Reporting Groups
  Description
FluBlok

Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

135μg total

TIV (Fluzone)

Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

45μg total

(Fluzone, sanofi pasteur)


Other Adverse Events
    FluBlok   TIV (Fluzone)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   4/300 (1.33%)   9/302 (2.98%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain †     
# participants affected / at risk   4/300 (1.33%)   9/302 (2.98%) 
# events   4   9 
Events were collected by systematic assessment



  Limitations and Caveats
  Hide 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa M. Dunkle, M.D., Chief Medical Officer
Organization: Protein Sciences Corporation
phone: 203-599-6064 ext 153
e-mail: ldunkle@proteinsciences.com


Publications of Results:

Responsible Party: Manon MJ Cox, Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT00539864     History of Changes
Other Study ID Numbers: PSC06
Study First Received: October 4, 2007
Results First Received: May 16, 2011
Last Updated: July 25, 2011