Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00657709
First received: April 2, 2008
Last updated: April 13, 2015
Last verified: April 2015
Results First Received: February 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Serogroup B Meningococcal Meningitis
Interventions: Biological: Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1)
Biological: Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2)
Biological: Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
Biological: Infanrix Hexa
Biological: Menjugate
Biological: Prevenar

  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
16 sites in Finland, 28 sites in the Czech Republic, 13 sites in Germany, 6 sites in Austria, 7 sites in Italy.

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
rMenB Lot1 Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot2 Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot3 Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Routine Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
MenC+ Routine Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.

Participant Flow:   Overall Study
    rMenB Lot1     rMenB Lot2     rMenB Lot3     Routine     MenC+ Routine  
STARTED     833     828     820     659     490  
COMPLETED     810     795     792     645     457  
NOT COMPLETED     23     33     28     14     33  
AE or Death                 7                 7                 6                 7                 1  
Withdrawal by Subject                 7                 15                 15                 5                 9  
Lost to Follow-up                 9                 9                 7                 1                 21  
Protocol Violation                 0                 2                 0                 1                 2  



  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
rMenB Lot1 Subjects received one injection of rMenB+OMV NZ (Lot 1) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot2 Subjects received one injection of rMenB+OMV NZ (Lot 2) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
rMenB Lot3 Subjects received one injection of rMenB+OMV NZ (Lot 3) at 2, 4, 6 months of age concomitantly with the routinely administered infant vaccines.
Routine Subjects received the routinely administered infant vaccines at 2, 4, 6 months of age.
MenC+ Routine Subjects received the routinely administered infant vaccines and Men C vaccine at 2, 4 and 6 months of age.
Total Total of all reporting groups

Baseline Measures
    rMenB Lot1     rMenB Lot2     rMenB Lot3     Routine     MenC+ Routine     Total  
Number of Participants  
[units: participants]
  833     828     820     659     490     3630  
Age  
[units: Days]
Mean (Standard Deviation)
  73.8  (9.5)     74.1  (9.6)     73.3  (9.4)     74.7  (9.3)     70.6  (9.7)     73.5  (9.5)  
Gender  
[units: Subjects]
           
Female     403     400     416     318     234     1771  
Male     430     428     404     341     256     1859  



  Outcome Measures
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1.  Primary:   The Geometric Mean Human Serum Bactericidal Activity (hSBA) Titers After Three Doses of rMenB+OMV NZ Vaccination   [ Time Frame: one month after the third vaccination ]

2.  Primary:   The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (3 Lots Combined)   [ Time Frame: one month after the third vaccination ]

3.  Secondary:   The Percentages of Subjects With hSBA Titer ≥1:5 After Receiving Three Doses of rMenB+OMV Vaccination (From 3 Lots)   [ Time Frame: 1 month after the third vaccination ]

4.  Secondary:   Geometric Mean Human Serum Bactericidal Activity Titers After the Routine Vaccination Without rMenB OMV NZ   [ Time Frame: 1 Month after the third vaccination ]

5.  Secondary:   Geometric Mean Concentrations After Three Doses of rMenB+OMV NZ Vaccination (Against the 287-953 Antigen)   [ Time Frame: 1 month after third vaccination ]

6.  Secondary:   Geometric Mean Concentrations for Antigens (Pertussis Components) for the Routine Vaccinations   [ Time Frame: 1 month after third vaccination ]

7.  Secondary:   Percentages of Subjects With Antibody Response Against the Routine Antigens   [ Time Frame: 1 Month after third vaccination ]

8.  Secondary:   Percentages of Subjects With Fourfold Increase in Antibody Concentrations Against the Routine Antigens   [ Time Frame: 5 months ]

9.  Secondary:   Percentages of Subjects With Fourfold Rise in hSBA Titers After Three Doses of rMenB+OMV NZ Vaccination   [ Time Frame: 1 Month after third vaccination ]

10.  Secondary:   Percentage of Subjects With hSBA Titers ≥1:8   [ Time Frame: 1 month after third vaccination ]

11.  Secondary:   Number of Subjects Reporting Solicited Adverse Events After Receiving Three Doses of rMenB+OMV NZ Vaccine   [ Time Frame: upto 7 days after any 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 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 by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00657709     History of Changes
Other Study ID Numbers: V72P13, EUDRACT 2007-007781-38
Study First Received: April 2, 2008
Results First Received: February 13, 2015
Last Updated: April 13, 2015
Health Authority: United States: Food and Drug Administration
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Austria: Federal Office for Safety in Health Care