Text Size

Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age

This study has been completed.
Sponsor:
Information provided by:
VaxInnate Corporation
ClinicalTrials.gov Identifier:
NCT00966238
First received: August 24, 2009
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
Results First Received: June 13, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: VAX125

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited across 3 clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
0.5 µg i.m. No text entered.
1.0 µg i.m. No text entered.
2.0 µg i.m. No text entered.
3.0 µg i.m. No text entered.
5.0 µg i.m. No text entered.
8.0 µg i.m. No text entered.

Participant Flow:   Overall Study
    0.5 µg i.m.     1.0 µg i.m.     2.0 µg i.m.     3.0 µg i.m.     5.0 µg i.m.     8.0 µg i.m.  
STARTED     20     20     20     20     20     20  
COMPLETED     20     20     20     20     20     20  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
0.5 µg i.m. No text entered.
1.0 µg i.m. No text entered.
2.0 µg i.m. No text entered.
3.0 µg i.m. No text entered.
5.0 µg i.m. No text entered.
8.0 µg i.m. No text entered.
Total Total of all reporting groups

Baseline Measures
    0.5 µg i.m.     1.0 µg i.m.     2.0 µg i.m.     3.0 µg i.m.     5.0 µg i.m.     8.0 µg i.m.     Total  
Number of Participants  
[units: participants]
 		  20     20     20     20     20     20     120  
Age  
[units: participants]
 		             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     0     0     0     0     0     0     0  
>=65 years     20     20     20     20     20     20     120  
Age  
[units: years]
Mean ± Standard Deviation 		  72.8  ± 6.12     71.2  ± 4.65     71.7  ± 4.16     71.9  ± 4.28     70.7  ± 4.07     70.6  ± 4.91     71.5  ± 4.71  
Gender  
[units: participants]
 		             
Female     10     7     10     5     12     9     53  
Male     10     13     10     15     8     11     67  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Local and Systemic Immediate Reactogenicity Complaints   [ Time Frame: within 4 hours following vaccination ]
  Show Outcome Measure 1

2.  Secondary:   Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers   [ Time Frame: 28 days after vaccination ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. David N. Taylor
Organization: VaxInnate
phone: 609-860-2260
e-mail: david.taylor@vaxinnate.com


No publications provided by VaxInnate Corporation

Publications automatically indexed to this study:


Responsible Party: David N. Taylor, MD, VaxInnate Corporation
ClinicalTrials.gov Identifier: NCT00966238     History of Changes
Other Study ID Numbers: VAX125-02
Study First Received: August 24, 2009
Results First Received: June 13, 2011
Last Updated: July 25, 2011
Health Authority: United States: Food and Drug Administration