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A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01478347
First received: November 21, 2011
Last updated: March 6, 2015
Last verified: March 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Intervention: Biological: Recombinant meningococcal B + OMV NZ

  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
Subjects were recruited from a single center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects participated in the study.

Reporting Groups
  Description
rMenB+OMV NZ Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.

Participant Flow for 2 periods

Period 1:   Visit 1-Visit 3 (Day 0-91) - Part I
    rMenB+OMV NZ  
STARTED     18  
COMPLETED     17  
NOT COMPLETED     1  
Lost to Follow-up                 1  

Period 2:   Visit 4-Visit 7 (Day 151-331) - Part II
    rMenB+OMV NZ  
STARTED     12  
COMPLETED     4  
NOT COMPLETED     8  
Lost to Follow-up                 4  
Withdrawal by Subject                 4  



  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.
Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures, were administered two injections of rMenB + OMV NZ vaccine, 2 months apart in part I (Visit 1-Visit 3). In part II (Visit 4-Visit 7), subjects were re-enrolled for optional blood draws and safety follow-up.

Reporting Groups
  Description
rMenB+OMV NZ

Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.

In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to "lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data.


Baseline Measures
    rMenB+OMV NZ  
Number of Participants  
[units: participants]
  18  
Age, Customized [1]
[units: years]
Mean (Standard Deviation)
 
rMenB (part I; N=18)     34.5  (5.7)  
rMenB (part II; N=11)     34.1  (5.6)  
Gender, Customized  
[units: subjects]
 
rMenB( part I; female)     13  
rMenB( part I; male)     5  
rMenB( part II; female)     8  
rMenB( part II; male)     3  
[1] Of the 18 subjects enrolled for part I of the study, only 12 subjects continued participation into protocol part II of the study. Of these, 11 subjects were included in safety set.



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.   [ Time Frame: Day 1 to day 91 ]

2.  Primary:   Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).   [ Time Frame: Day 92 to day 331 ]


  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 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: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01478347     History of Changes
Other Study ID Numbers: V72_37
Study First Received: November 21, 2011
Results First Received: February 20, 2015
Last Updated: March 6, 2015
Health Authority: EMA: European Medicinal Agency