Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00661713
First received: April 16, 2008
Last updated: October 7, 2015
Last verified: October 2015
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Meningococcal Disease
Interventions: Biological: rMenB+OMV NZ
Biological: Placebo

  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 10 study centers 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 received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
rMenB0 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
rMenB016 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
rMenB01 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
rMenB026 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
rMenB02 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
rMenB012 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
rMenB6 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.

Participant Flow:   Overall Study
    rMenB06     rMenB0     rMenB016     rMenB01     rMenB026     rMenB02     rMenB012     rMenB6  
STARTED     128     247     128     247     127     253     373     128  
COMPLETED     112     208     111     219     107     216     309     117  
NOT COMPLETED     16     39     17     28     20     37     64     11  
Death                 1                 0                 0                 0                 1                 0                 0                 0  
Unable to Classify                 1                 0                 0                 0                 0                 0                 0                 0  
Protocol Violation                 1                 6                 3                 3                 0                 2                 2                 1  
Withdrawal by Subject                 11                 25                 12                 21                 12                 26                 45                 9  
Lost to Follow-up                 2                 7                 2                 2                 5                 7                 14                 1  
Administrative Reason                 0                 1                 0                 2                 2                 2                 1                 0  
Adverse Event                 0                 0                 0                 0                 0                 0                 1                 0  
Inappropriate Enrollment                 0                 0                 0                 0                 0                 0                 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.
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Reporting Groups
  Description
rMenB06 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 6 months and placebo at 1 and 2 months.
rMenB0 Subjects received 1 dose of rMenB+OMV-NZ at 0 month and 3 doses of placebo at 1, 2 and 6 months.
rMenB016 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 6 months and 1 dose of placebo at 2 months.
rMenB01 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 1 months and placebo at 2 and 6 months.
rMenB026 Subjects received 3 doses of rMenB+OMV-NZ at 0, 2 and 6 months and 1 dose of placebo at 1 month.
rMenB02 Subjects received 2 doses each of rMenB+OMV-NZ at 0 and 2 months and placebo at 1 and 6 months.
rMenB012 Subjects received 3 doses of rMenB+OMV-NZ at 0, 1 and 2 months and placebo at 6 months.
rMenB6 Subjects received 1 dose of rMenB+OMV-NZ at 6 months and 3 doses of placebo at 0, 1 and 2 months.
Total Total of all reporting groups

Baseline Measures
    rMenB06     rMenB0     rMenB016     rMenB01     rMenB026     rMenB02     rMenB012     rMenB6     Total  
Number of Participants  
[units: participants]
  128     247     128     247     127     253     373     128     1631  
Age  
[units: years]
Mean (Standard Deviation)
  13.8  (1.9)     13.8  (1.9)     13.9  (1.9)     13.9  (1.9)     13.7  (1.9)     13.7  (1.8)     13.8  (1.9)     13.8  (2)     13.8  (1.9)  
Gender  
[units: participants]
                 
Female     76     147     76     138     73     138     199     66     913  
Male     52     100     52     109     54     115     174     62     718  



  Outcome Measures
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1.  Primary:   Percentages ‘of Subjects With hSBA Titer ≥1:4 After Receiving One, Two or Three Doses of rMenB+OMV NZ Vaccine.   [ Time Frame: Month-1, 2, 3 ]

2.  Primary:   Number of Subjects With Local Reactions and Systemic Reactions Occurring in Days 1 to 7 After Vaccination   [ Time Frame: 1 to 7 days after each vaccination ]

3.  Secondary:   Percentages of Subjects With hSBA Titer ≥1:4 After Receiving a Booster Dose of rMenB+OMV NZ Vaccine at Month 6.   [ Time Frame: Month-6 & 7 ]

4.  Secondary:   Percentage of Subjects With hSBA Titer ≥1:8 After Primary and Booster Vaccination.   [ Time Frame: at baseline, month-1, month-2, month-3, month-6 and month-7. ]

5.  Secondary:   Percentages of Subjects With at Least a Fourfold Rise in hSBA Titer Over the Prevaccination and After Booster Vaccination.   [ Time Frame: Month-1, month-2, month-3 and month-7 ]

6.  Secondary:   Geometric Mean Titers (GMTs) After Primary and Booster Vaccination.   [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ]

7.  Secondary:   Geometric Mean Ratios (GMRs) After Primary and Booster Vaccination.   [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ]

8.  Secondary:   GMCs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination.   [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ]

9.  Secondary:   GMRs of Antibodies Against 287-953Antigen (ELISA) After Primary and Booster Vaccination   [ Time Frame: month-1, month-2, month-3, month-6 and month-7 ]

10.  Secondary:   Number of Subjects Reporting Unsolicited AEs Throughout the Study.   [ Time Frame: Throughout the 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 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
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00661713     History of Changes
Other Study ID Numbers: V72P10
Study First Received: April 16, 2008
Results First Received: February 3, 2015
Last Updated: October 7, 2015
Health Authority: United States: Food and Drug Administration
Chile: División de Prevención y Control de Enfermedades