Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster or as a Two-dose Catch-up to Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00847145
First received: February 18, 2009
Last updated: March 2, 2015
Last verified: March 2015
Results First Received: February 3, 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 Disease
Interventions: Biological: 1a - rMenB+OMV NZ and routine vaccines
Biological: 1b - rMenB+OMV NZ and routine vaccines
Biological: 2a - Routine and rMenB+OMV NZ vaccines
Biological: 2b - rMenB+OMV NZ and routine vaccines
Biological: 3a - rMenB+OMV NZ and routine vaccines
Biological: 3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
Biological: 4a- rMenB+OMV NZ and routine vaccines
Biological: 4b - rMenB+OMV NZ and routine vaccines

  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 15 sites in Finland, 12 sites in Germany, 5 sites in Austria, 27 sites in Czech Republic and 6 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
12B12M (1a) Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (1b) Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
12M13B15B (2a) Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
12M12B14B (2b) Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
12B12M (3a) Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (3b) Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
12B12M_C (4a) Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M_C (4b) Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.

Participant Flow:   Overall Study
    12B12M (1a)     12B13M (1b)     12M13B15B (2a)     12M12B14B (2b)     12B12M (3a)     12B13M (3b)     12B12M_C (4a)     12B13M_C (4b)  
STARTED     629     633     285     117     137     156     152     140  
COMPLETED     623     627     274     116     131     152     143     136  
NOT COMPLETED     6     6     11     1     6     4     9     4  
AE or Death                 0                 1                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 3                 4                 6                 1                 0                 0                 1                 1  
Lost to Follow-up                 3                 1                 1                 0                 4                 4                 8                 2  
Inappropriate enrollment                 0                 0                 0                 0                 1                 0                 0                 0  
Protocol Violation                 0                 0                 3                 0                 1                 0                 0                 1  



  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
12B12M (1a) Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (1b) Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
12M13B15B (2a) Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
12M12B14B (2b) Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
12B12M (3a) Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M (3b) Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
12B12M_C (4a) Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
12B13M_C (4b) Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
Total Total of all reporting groups

Baseline Measures
    12B12M (1a)     12B13M (1b)     12M13B15B (2a)     12M12B14B (2b)     12B12M (3a)     12B13M (3b)     12B12M_C (4a)     12B13M_C (4b)     Total  
Number of Participants  
[units: participants]
  629     633     285     117     137     156     152     140     2249  
Age  
[units: years]
Mean (Standard Deviation)
  12.3  (0.5)     12.3  (0.5)     12.3  (0.5)     12.3  (0.5)     12.2  (0.5)     12.2  (0.4)     12.2  (0.5)     12.2  (0.4)     12.3  (0.5)  
Gender  
[units: participants]
                 
Female     290     330     131     55     75     81     62     73     1097  
Male     339     303     154     62     62     75     90     67     1152  



  Outcome Measures
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1.  Primary:   Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination   [ Time Frame: one month after the booster (fourth) dose ]

2.  Secondary:   Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination   [ Time Frame: one month after booster (fourth) dose ]

3.  Secondary:   The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination   [ Time Frame: one month after booster (fourth) vaccination. ]

4.  Secondary:   Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)   [ Time Frame: one month after third vaccination and pre dose fourth (booster) vaccination ]

5.  Secondary:   Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)   [ Time Frame: One month post vaccination and pe-booster (fourth) dose vaccination ]

6.  Secondary:   Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)   [ Time Frame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination ]

7.  Secondary:   SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule   [ Time Frame: One month after the second dose. ]

8.  Secondary:   Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule   [ Time Frame: One month after the second dose. ]

9.  Secondary:   ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months   [ Time Frame: One month after the fourth (booster) dose. ]

10.  Secondary:   ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers   [ Time Frame: One month after the first dose and one month after the second dose. ]

11.  Secondary:   Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months   [ Time Frame: One month after the fourth (booster) dose. ]

12.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age   [ Time Frame: From day 1 to day 7 after each rMenB+OMV NZ vaccination. ]

13.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination   [ Time Frame: From day 1 to day 7 after each rMenB+MV NZ vaccination. ]

14.  Secondary:   Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age   [ Time Frame: From day 1 to day 7 after MMRV vaccination. ]

15.  Secondary:   Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age   [ Time Frame: From day 8 to day 28 after MMRV 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
None reported.


  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: NCT00847145     History of Changes
Other Study ID Numbers: V72P13E1, 2008-006301-17
Study First Received: February 18, 2009
Results First Received: February 3, 2015
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration
Italy: AIFA
Finland: NAM
Germany: PEI
Czech Republic: SUKL
Austria: Austrian Federal Agency for Safety in Health Care (BSAG)