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Safety, Tolerability and Immunogenicity of Three Doses of Novartis Meningococcal B Vaccine When Administered to Healthy At-risk Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00560313
First received: November 16, 2007
Last updated: December 8, 2011
Last verified: December 2011
Results First Received: June 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Meningococcal Disease
Interventions: Biological: Men ACWY CRM
Biological: 4CMenB

  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
Participants were enrolled at one site in Italy and one site in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Approximately 250 adults were planned to be enrolled in this study but only a total of 54 subjects were enrolled after the screening for the inclusion and exclusion criteria.

Reporting Groups
  Description
4CMenB All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB

Participant Flow:   Overall Study
    4CMenB  
STARTED     54  
COMPLETED     48  
NOT COMPLETED     6  



  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
4CMenB All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB

Baseline Measures
    4CMenB  
Number of Participants  
[units: participants]
  54  
Age  
[units: years]
Mean ± Standard Deviation
  31.8  ± 6.1  
Gender  
[units: participants]
 
Female     27  
Male     27  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer of the Meningococcal B Vaccine Against the Different Strains at One Month After First, Second and Third Vaccination   [ Time Frame: one month after vaccination ]

2.  Primary:   Percentages of Participants With Serum Bactericidal Activity of the Meningococcal B Vaccine Against Different Strains at One Month After First, Second and Third Vaccination   [ Time Frame: one month after vaccination ]

3.  Primary:   Geometric Mean Titer (GMT) of the Meningococcal ACWY Vaccine at One Month After Vaccination   [ Time Frame: one month after vaccination ]

4.  Primary:   Percentage of Participants With Serum Bactericidal Activity of the Meningococcal ACWY Vaccine at One Month After Vaccination   [ Time Frame: one month after vaccination ]

5.  Primary:   Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination   [ Time Frame: one month after vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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
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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.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


Publications of Results:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00560313     History of Changes
Other Study ID Numbers: V72P4, 2007-001563-29
Study First Received: November 16, 2007
Results First Received: June 6, 2011
Last Updated: December 8, 2011
Health Authority: Germany: Paul-Ehrlich-Institut