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Intradermal Influenza Vaccine Study in Elders

This study has been completed.
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Information provided by (Responsible Party):
Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier:
NCT00504231
First received: July 12, 2007
Last updated: June 8, 2012
Last verified: July 2011
History of Changes
Results First Received: January 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Fluzone Influenza Vaccine (2007-2008)

  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
No text entered.

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
Full-dose 0.5 mL IM 0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
60% Dose 0.3 mL IM 0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
60% Dose 0.3 mL ID 0.3 mL influenza vaccine delivered intradermally
60% Dose 0.15 mL x 2 ID 0.15 mL influenza vaccine twice delivered intradermally with needle and syringe

Participant Flow:   Overall Study
    Full-dose 0.5 mL IM     60% Dose 0.3 mL IM     60% Dose 0.3 mL ID     60% Dose 0.15 mL x 2 ID  
STARTED     65     64     64     65  
COMPLETED     65     64     63     65  
NOT COMPLETED     0     0     1     0  
Discrepant chart documentation re route                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Full-dose 0.5 mL IM 0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
60% Dose 0.3 mL IM 0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
60% Dose 0.3 mL ID 0.3 mL influenza vaccine delivered intradermally
60% Dose 0.15 mL x 2 ID 0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
Total Total of all reporting groups

Baseline Measures
    Full-dose 0.5 mL IM     60% Dose 0.3 mL IM     60% Dose 0.3 mL ID     60% Dose 0.15 mL x 2 ID     Total  
Number of Participants  
[units: participants]
 		  65     64     63     65     257  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     65     64     63     65     257  
Age  
[units: years]
Mean ± Standard Deviation 		  75.6  ± 6.8     75.2  ± 7.7     73.6  ± 6.3     74.7  ± 6.3     74.8  ± 6.8  
Gender  
[units: participants]
 		         
Female     11     11     11     11     44  
Male     54     53     52     54     213  
Ethnicity (NIH/OMB)  
[units: participants]
 		         
Hispanic or Latino     0     1     1     1     3  
Not Hispanic or Latino     65     63     62     64     254  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
 		         
American Indian or Alaska Native     0     0     0     0     0  
Asian     2     0     2     2     6  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     4     2     3     5     14  
White     56     60     55     53     224  
More than one race     0     0     0     0     0  
Unknown or Not Reported     3     2     3     5     13  



  Outcome Measures
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1.  Primary:   Seroprotection Pre- and Post- Vaccination   [ Time Frame: 1 month ]
  Show Outcome Measure 1

2.  Secondary:   Geometric Mean Titer (GMT) Pre- and Post- Vaccination   [ Time Frame: 1 month ]
  Show Outcome Measure 2

3.  Secondary:   Assessment of Reactogenicity   [ Time Frame: 1 week ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  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.


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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Results Point of Contact:  
Name/Title: Ru-Chien Chi B.S., M.D., M.S.
Organization: University of Washington
phone: 206 768-5217
e-mail: rchi@u.washington.edu


No publications provided by Program for Appropriate Technology in Health

Publications automatically indexed to this study:


Responsible Party: Program for Appropriate Technology in Health
ClinicalTrials.gov Identifier: NCT00504231     History of Changes
Other Study ID Numbers: ID/RD01
Study First Received: July 12, 2007
Results First Received: January 11, 2012
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration