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Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01148524
First received: June 4, 2010
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: December 11, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Interventions: Biological: No Vaccine
Biological: rMenB+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 enrolled at six study sites in Chile.

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

Reporting Groups
  Description
rMenB06 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
rMenB0 Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
rMenB016 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
rMenB01 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
rMenB026 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
rMenB02 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
rMenB012 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
rMenB6 Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
Naive Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines

Participant Flow:   Overall Study
    rMenB06     rMenB0     rMenB016     rMenB01     rMenB026     rMenB02     rMenB012     rMenB6     Naive  
STARTED     49     95     53     102     57     106     153     51     151  
COMPLETED     49     95     53     102     57     106     153     51     151  
NOT COMPLETED     0     0     0     0     0     0     0     0     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.
Analysis was performed on all enrolled subjects.

Reporting Groups
  Description
rMenB06 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
rMenB0 Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
rMenB016 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
rMenB01 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
rMenB026 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
rMenB02 Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
rMenB012 Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
rMenB6 Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
Naive Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
Total Total of all reporting groups

Baseline Measures
    rMenB06     rMenB0     rMenB016     rMenB01     rMenB026     rMenB02     rMenB012     rMenB6     Naive     Total  
Number of Participants  
[units: participants]
  49     95     53     102     57     106     153     51     151     817  
Age  
[units: Years]
Mean ± Standard Deviation
  16.2  ± 1.9     16.0  ± 2.0     16.2  ± 2.1     16.1  ± 1.9     15.6  ± 1.9     15.9  ± 1.8     15.9  ± 1.9     16.0  ± 1.9     15.6  ± 1.7     15.9  ± 1.9  
Gender  
[units: Subjects]
                   
Female     30     53     33     57     38     61     96     33     61     462  
Male     19     42     20     45     19     45     57     18     90     355  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects   [ Time Frame: 18 months after last vaccination in V72P10 study ]

2.  Primary:   Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects   [ Time Frame: 18 months after last vaccination in V72P10 study ]

3.  Primary:   Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study   [ Time Frame: 18 months after last vaccination in V72P10 study ]

4.  Primary:   Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects   [ Time Frame: 18 months after last vaccination V72P10 study ]


  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 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


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01148524     History of Changes
Other Study ID Numbers: V72P10E1
Study First Received: June 4, 2010
Results First Received: December 11, 2013
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration