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A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier:
NCT00877448
First received: January 28, 2009
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
Results First Received: August 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Healthy
Interventions: Biological: Adjuvanted Multimeric-001 250 Mcg
Biological: Multimeric-001 250 Mcg
Biological: Phosphate Buffered saline
Biological: Adjuvanted PBS
Biological: Adjuvanted Multimeric-001 500 Mcg
Biological: Multimeric-001 500 Mcg
Biological: Multimeric-001 125 Mcg

  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
Recruitment was done on a running basis after eligibility of inclusion/exclusion criteria was met and subjects were invited to clinic after screening procedures within up to 21 days before their first vaccination.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After meeting eligibility criteria to enter the study subjects were randomized simultaneously.

Reporting Groups
  Description
Multimeric-001 250 Mcg in PBS Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
Adjuvanted Multimeric -001 250 Mcg Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
PBS (Placebo) 0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
Adjuvanted PBS Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
Multimeric-001 in PBS 500 Mcg Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
Adjuvanted Multimeric-001 500 Mcg Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
Multimeric-001 125 Mcg Multimeric-001 125 mcg in PBS administered once only.

Participant Flow:   Overall Study
    Multimeric-001 250 Mcg in PBS     Adjuvanted Multimeric -001 250 Mcg     PBS (Placebo)     Adjuvanted PBS     Multimeric-001 in PBS 500 Mcg     Adjuvanted Multimeric-001 500 Mcg     Multimeric-001 125 Mcg  
STARTED     10     10     10     10     10     10     3  
COMPLETED     10     9     10     9     10     9     3  
NOT COMPLETED     0     1     0     1     0     1     0  



  Baseline Characteristics
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Reporting Groups
  Description
Multimeric-001 250 Mcg in PBS Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
Adjuvanted Multimeric -001 250 Mcg Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
PBS (Placebo) 0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
Adjuvanted PBS Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
Multimeric-001 in PBS 500 Mcg Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
Adjuvanted Multimeric-001 500 Mcg Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
Multimeric-001 125 Mcg Multimeric-001 125 mcg in PBS administered once only.
Total Total of all reporting groups

Baseline Measures
    Multimeric-001 250 Mcg in PBS     Adjuvanted Multimeric -001 250 Mcg     PBS (Placebo)     Adjuvanted PBS     Multimeric-001 in PBS 500 Mcg     Adjuvanted Multimeric-001 500 Mcg     Multimeric-001 125 Mcg     Total  
Number of Participants  
[units: participants]
 		  10     10     10     10     10     10     3     63  
Age  
[units: participants]
 		               
<=18 years     0     0     0     0     0     0     0     0  
Between 18 and 65 years     10     10     10     10     10     10     3     63  
>=65 years     0     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  24.3  ± 4.0     25.8  ± 8.8     25.2  ± 5.3     26.0  ± 8.4     29.0  ± 7.4     25.2  ± 4.5     25.7  ± 3.3     25.9  ± 6.4  
Gender  
[units: participants]
 		               
Female     8     10     8     9     6     10     3     54  
Male     2     0     2     1     4     0     0     9  
Region of Enrollment  
[units: participants]
 		               
Israel     10     10     10     10     10     10     3     63  



  Outcome Measures
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1.  Primary:   Adverse Events   [ Time Frame: day 0 until day 42 (termination visit) ]
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2.  Primary:   Treatment-related Adverse Events   [ Time Frame: Day 0 until day 42 (termination visit) ]
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  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 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: Tamar Ben-Yedidia, PhD
Organization: BiondVax Pharmaceuticals Ltd.
phone: 972-8-9302529
e-mail: benyedidia@BiondVax.com


Publications of Results:


Responsible Party: BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier: NCT00877448     History of Changes
Other Study ID Numbers: BVX002
Study First Received: January 28, 2009
Results First Received: August 1, 2012
Last Updated: February 20, 2013
Health Authority: Israel: Ministry of Health