Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00721396
First received: July 22, 2008
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: February 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Meningococcal Infections
Interventions: Biological: rMenB+OMV NZ
Biological: combined diphtheria,tetanus,pertussis+polio+Hepatitis B+Haemophilus influenzae B vaccine
Biological: Pneumococcal vaccine

  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 4 centers in UK, 5 centers in Italy, 16 centers in Spain, 6 centers in Belgium, 25 centers in Germany and 4 centers in Czech Republic

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

Reporting Groups
  Description
B+R246 Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
B246_R357 Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
B+R234 Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
R234 Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.

Participant Flow:   Overall Study
    B+R246     B246_R357     B+R234     R234  
STARTED     627     628     318     312  
COMPLETED     597     592     308     302  
NOT COMPLETED     30     36     10     10  
Adverse Event                 4                 7                 2                 0  
Withdrawal by Subject                 12                 15                 3                 7  
Lost to Follow-up                 7                 9                 3                 3  
Protocol Violation                 4                 3                 1                 0  
Inappropriate enrollment                 0                 2                 0                 0  
Administrative reason                 3                 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.
No text entered.

Reporting Groups
  Description
B+R246 Subjects in this group received rMenB+OMV NZ vaccine at 2, 4, and 6 months of age, administered concomitantly with routine infant vaccinations
B246_R357 Subjects in this group received rMenB+OMV NZ vaccine at at 2, 4, and 6 months of age; routine infant vaccinations were administered at 3, 5 and 7 months of age
B+R234 Subjects in this group received rMenB+OMV NZ vaccine at 2, 3, 4 months of age, administered concomitantly with routine infant vaccinations
R234 Subjects in this group received routine infant vaccines administered at 2, 3 and 4 months of age.
Total Total of all reporting groups

Baseline Measures
    B+R246     B246_R357     B+R234     R234     Total  
Number of Participants  
[units: participants]
  627     628     318     312     1885  
Age  
[units: days]
Mean (Standard Deviation)
  68.7  (8.9)     68.8  (9.4)     68.8  (9.1)     68.1  (9.0)     68.7  (9.1)  
Gender  
[units: subjects]
         
Female     292     312     164     159     927  
Male     335     316     154     153     958  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Serum Bactericidal Activity ≥1:5 After Receiving Three Doses of rMenB+OMV NZ Vaccine   [ Time Frame: One month after third Men B vaccination ]

2.  Primary:   Safety and Tolerability of 3 Doses of rMenB - Concomitantly With Routine Infant Vaccines at 2, 4 and 6 Months of Age - Concomitantly With Routine Vaccines at 2, 3 and 4 Months of Age - Alone at 2, 4 and 6 Months of Age   [ Time Frame: 10 months (groups 1 and 2); 8 months (groups 3 and 4) ]

3.  Secondary:   Non-inferiority of Immune Response to rMenB+OMV NZ Vaccination When Administered Concomitantly With Routine Infant Vaccines at 2,4,6 Months of Age   [ Time Frame: One month after 3rd Men B vaccination ]

4.  Secondary:   Non-inferiority of Immune Response to Diphtheria and Tetanus Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine   [ Time Frame: One month after 3rd vaccination ]

5.  Secondary:   Geometric Mean Titers Against Neisseria Meningitidis Serogroup B, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.   [ Time Frame: One month after third Men B vaccination ]

6.  Secondary:   Geometric Mean Ratio of hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.   [ Time Frame: one month after third Men B vaccination ]

7.  Secondary:   Percentage of Subjects With hSBA ≥1:8 After Receiving Three Doses of rMenB+OMV NZ Vaccine.   [ Time Frame: One month after third Men B vaccination ]

8.  Secondary:   Percentage of Subjects With 4-fold Rise in hSBA Titers, When rMenB+OMV NZ Vaccine is Administered Concomitantly With Routine Infant Vaccines.   [ Time Frame: One month after third Men B vaccination ]

9.  Secondary:   Non-inferiority of Immune Response to Acellular Pertussis Antigens When Routine Vaccines Are Administered Concomitantly With rMen+OMV NZ Vaccine.   [ Time Frame: 1 month after 3rd 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: NCT00721396     History of Changes
Other Study ID Numbers: V72P12
Study First Received: July 22, 2008
Results First Received: February 18, 2015
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Czech Republic: State Institute for Drug Control