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Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01229397
First received: October 22, 2010
Last updated: January 7, 2014
Last verified: August 2013
History of Changes
Results First Received: October 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Inflexal V

  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 period: 05 October - 17 January 2011; Location: University of Milan

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
Inflexal V 0.25 mL x 2

2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:

  • 7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus
  • 7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 7.5 μg HA antigen of B/Brisbane/60/2008-like virus
Inflexal V 0.5 mL x 1

1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:

  • 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
  • 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
  • 15 μg HA antigen of B/Brisbane/60/2008-like virus

Participant Flow:   Overall Study
    Inflexal V 0.25 mL x 2     Inflexal V 0.5 mL x 1  
STARTED     103     102  
COMPLETED     92     93  
NOT COMPLETED     11     9  
Withdrawal by Subject                 3                 3  
Lost to Follow-up                 7                 6  
Migrated/moved from study area                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inflexal V 0.25 mL x 2 Two 0.25 mL doses (on Day 1 and 29)
Inflexal V 0.5 mL x 1 One 0.5 mL dose (on Day 1)
Total Total of all reporting groups

Baseline Measures
    Inflexal V 0.25 mL x 2     Inflexal V 0.5 mL x 1     Total  
Number of Participants  
[units: participants]
 		  103     102     205  
Age  
[units: participants]
 		     
<=18 years     103     102     205  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation) 		  1.8  (0.52)     1.8  (0.61)     1.8  (0.57)  
Gender  
[units: participants]
 		     
Female     37     37     74  
Male     66     65     131  
Region of Enrollment  
[units: participants]
 		     
Italy     103     102     205  



  Outcome Measures
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1.  Primary:   Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference   [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
  Show Outcome Measure 1

2.  Primary:   Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference   [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
  Show Outcome Measure 2

3.  Primary:   Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference   [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Medical Affairs Director
Organization: Crucell Switzerland AG
phone: +41(0)319806111
e-mail: info@crucell.com



Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01229397     History of Changes
Other Study ID Numbers: INF-V-A005
Study First Received: October 22, 2010
Results First Received: October 23, 2012
Last Updated: January 7, 2014
Health Authority: Italy: Ministry of Health