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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:
ClinicalTrials.gov Identifier:
NCT00657709
First Posted: April 14, 2008
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
Results First Submitted: February 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      403  48.4%      400  48.3%      416  50.7%      318  48.3%      234  47.8%      1771  48.8% 
Male      430  51.6%      428  51.7%      404  49.3%      341  51.7%      256  52.2%      1859  51.2% 


  Outcome Measures
  Show All Outcome Measures

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00657709     History of Changes
Other Study ID Numbers: V72P13
EUDRACT 2007-007781-38
First Submitted: April 2, 2008
First Posted: April 14, 2008
Results First Submitted: February 13, 2015
Results First Posted: April 10, 2015
Last Update Posted: October 10, 2017