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Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01717638
First received: October 18, 2012
Last updated: December 29, 2014
Last verified: December 2014
Results First Received: October 1, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Interventions: Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Biological: 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed 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 enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.

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

Reporting Groups
  Description
B+R246_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R246_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R246_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_12_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_18_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_24_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B12 14_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B18 20_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B24 26_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B48_50 Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.

Participant Flow:   Overall Study
    B+R246_12_48   B+R246_18_48   B+R246_24_48   B246_12_48   B246_18_48   B246_24_48   B+R234_12_48   B+R234_18_48   B+R234_24_48   B12 14_48   B18 20_48   B24 26_48   B48_50
STARTED   67   61   60   66   64   55   43   29   28   100   11   12   209 
COMPLETED   67   60   59   66   63   54   41   28   26   99   11   12   190 
NOT COMPLETED   0   1   1   0   1   1   2   1   2   1   0   0   19 
Lost to Follow-up                0                0                0                0                0                1                0                0                0                0                0                0                0 
Father in hospital                0                0                0                0                0                0                0                0                0                0                0                0                1 
Withdrawal by Subject                0                1                1                0                1                0                2                1                2                1                0                0                18 



  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.
Anaysis was done on the all enrolled population, ie, all subjects who have signed an informed consent, undergone screening procedure(s) and were randomized.

Reporting Groups
  Description
B+R246_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R246_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R246_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_12_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_18_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B246_24_48 Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_12_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_18_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B+R234_24_48 Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B12 14_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B18 20_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B24 26_48 Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
B48 50 Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
Total Total of all reporting groups

Baseline Measures
   B+R246_12_48   B+R246_18_48   B+R246_24_48   B246_12_48   B246_18_48   B246_24_48   B+R234_12_48   B+R234_18_48   B+R234_24_48   B12 14_48   B18 20_48   B24 26_48   B48 50   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   61   60   66   64   55   43   29   28   100   11   12   209   805 
Age 
[Units: Months]
Mean (Standard Deviation)
 51.8  (3.4)   52.1  (3.4)   51.7  (3.5)   51.7  (3.5)   51.3  (3.7)   52.3  (3.7)   51.8  (3.4)   51.4  (3.4)   53.1  (3.5)   51.7  (3.3)   53.4  (4.3)   56.8  (1.5)   53.7  (3.6)   52.4  (3.6) 
Gender 
[Units: Participants]
                           
Female   23   28   33   28   32   30   24   17   13   50   6   4   99   387 
Male   44   33   27   38   32   25   19   12   15   50   5   8   110   418 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (24-36 months post booster; baseline for naive) ]

2.  Primary:   Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (24-36 months post booster; baseline for naive) ]

3.  Primary:   Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (24-36 months post booster dose; baseline for naive) ]

4.  Secondary:   Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (22-34 months post last MenB vaccine) ]

5.  Secondary:   Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (22-36 months post last MenB vaccine; baseline for naive) ]

6.  Secondary:   GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules   [ Time Frame: Day 1 (22-34 months post last MenB vaccine) ]

7.  Secondary:   Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

8.  Secondary:   GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

9.  Secondary:   Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

10.  Secondary:   Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

11.  Secondary:   Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

12.  Secondary:   GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules   [ Time Frame: Day 31 (1 month post vaccination) ]

13.  Secondary:   GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.   [ Time Frame: Day 31 (1 month post vaccination) ]

14.  Secondary:   Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine   [ Time Frame: Day 31 (1 month post vaccination) ]

15.  Secondary:   Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.   [ Time Frame: Day 91 (1 month post second vaccination) ]

16.  Secondary:   GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age   [ Time Frame: Day 91 (1 month post second vaccination) ]

17.  Secondary:   GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age   [ Time Frame: Day 91 (1 month post second vaccination) ]

18.  Secondary:   Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age   [ Time Frame: Day 91 (1 month post second vaccination) ]

19.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)   [ Time Frame: From day 1 to day 7 after vaccination ]

20.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)   [ Time Frame: From day 1 to day 7 after vaccination ]

21.  Secondary:   Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age   [ Time Frame: From day 1 to day 7 after any vaccination ]

22.  Secondary:   Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)   [ Time Frame: From day 1 to study termination ]

23.  Secondary:   Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)   [ Time Frame: From day 1 to study termination ]

24.  Secondary:   Number of Subjects Reporting Unsolicited AEs After Any Vaccination.   [ Time Frame: From day 1 to study termination ]


  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 and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01717638     History of Changes
Other Study ID Numbers: V72P12E2
2011-004931-30 ( EudraCT Number )
Study First Received: October 18, 2012
Results First Received: October 1, 2014
Last Updated: December 29, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: Italian Medicines Agency