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
  Purpose

It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV NZ administered to toddlers as part of their respective vaccination courses in study V72P12E1.

In addition, this study will characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12, NCT00721396), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at approximately 4 years of age in all children who received a two catch-up doses of rMenB+OMV NZ as toddlers in study V72P12E1.

Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Biological: 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fifth Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.

    The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA).


  • 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) ] [ Designated as safety issue: No ]
    The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).

  • 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) ] [ Designated as safety issue: No ]
    The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.

  • 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) ] [ Designated as safety issue: No ]
    The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.

  • 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) ] [ Designated as safety issue: No ]
    The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.

  • 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) ] [ Designated as safety issue: No ]
    The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.

  • 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) ] [ Designated as safety issue: No ]
    The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.

  • 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) ] [ Designated as safety issue: No ]
    The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.

  • 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) ] [ Designated as safety issue: No ]
    The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.

  • 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) ] [ Designated as safety issue: No ]
    The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

  • 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) ] [ Designated as safety issue: No ]
    The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.

  • 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) ] [ Designated as safety issue: No ]
    The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.

  • 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) ] [ Designated as safety issue: No ]

    The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.

    Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer.


  • 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) ] [ Designated as safety issue: No ]

    The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.

    Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.

    Immune sufficiency was not applicable for M10713 strain.


  • 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) ] [ Designated as safety issue: No ]
    The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

  • 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) ] [ Designated as safety issue: No ]
    The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.

  • 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) ] [ Designated as safety issue: No ]
    The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.

  • 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 ] [ Designated as safety issue: No ]
    The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.

  • 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 ] [ Designated as safety issue: No ]
    The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.

  • 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 ] [ Designated as safety issue: No ]
    The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.

  • 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 ] [ Designated as safety issue: No ]
    The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.

  • 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 ] [ Designated as safety issue: No ]
    The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.

  • Number of Subjects Reporting Unsolicited AEs After Any Vaccination. [ Time Frame: From day 1 to study termination ] [ Designated as safety issue: No ]
    The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.


Enrollment: 805
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B+R246_12_48
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B+R246_18_48
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B+R246_24_48
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B246_12_48
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B246_18_48
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B246_24_48
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B+R234_12_48
Previously received 3 doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B+R234_18_48
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B+R234_24_48
Previously received rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B12 14_48
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine at 12 and14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B18 20_48
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B24 26_48
Previously received two catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed 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.
Biological: 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
Other Name: rMenB+OMV NZ
Experimental: B48_50
Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ, ie, Meningococcal (group B) multicomponent recombinant adsorbed vaccine, two months apart, in the present study.
Biological: 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
Other Name: rMenB+OMV NZ

  Eligibility

Ages Eligible for Study:   48 Months to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A. Inclusion Criteria for naïve subjects, newly enrolled (B48_50):

  1. 4 years old (48 to 60 months) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. The age window is defined as the first day the subject turns 4 years old up to the day before the subject turns 5 years old.
  2. For whom parent/legal guardian(s) has given written informed consent after the nature of the study has been explained.
  3. For whom parent/legal guardian(s) confirmed availability for the visit(s) scheduled in the study.
  4. In good health as determined by medical history, physical examination, clinical judgment of the investigator.

B. Inclusion Criteria for follow-on participants (Groups 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):

Inclusion criteria are the same as for Group B48_50, with the addition that they are subjects who completed the vaccination course of V72P12E1 study.

Exclusion Criteria:

A. Exclusion Criteria for naïve subjects, newly enrolled (Group 7):

  1. Subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study.
  2. History of any meningococcal B vaccine administration.
  3. Previous ascertained or suspected disease caused by N. meningitidis.
  4. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
  5. History of allergic reaction to any vaccine component.
  6. Significant chronic infection.
  7. Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
  8. Known or suspected impairment/alteration of the immune system resulting from (for example) receipt of chronic immunosuppressive therapy or immunostimulants.
  9. Participation in another clinical trial within 90 days prior to enrolment or planned for during study.
  10. Family members and household members of research staff.
  11. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

B. Exclusion Criteria for follow-on participants ((Groups 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):

Exclusion criteria are the same as for Group B48_50, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 9.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717638

Locations
Czech Republic
Ordinace praktickeho lekare pro deti a dorost
Jaromer, Alšova 466, Czech Republic, 55101
Ordinace praktickeho lekare pro deti a dorost
Jaromer, Dr. E.Beneše 191, Czech Republic, 55101
Ordinace praktickeho lekare pro deti a dorost
Sezemice, Havlickova 168, Czech Republic, 53304
Ordinace praktickeho lekare pro deti a dorost
Hronov, Hostovského 485, Czech Republic, 54931
Ordinace praktickeho lekare pro deti a dorost
Ceska Skalice, Husovo namesti 36, Czech Republic, 55203
Ordinace praktickeho lekare pro deti a dorost
Pardubice, L.Male 656, Czech Republic, 53012
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Manesova 646, Czech Republic, 50002
Ordinace praktickeho lekare pro deti a dorost
Hronov, Palackeho 517, Czech Republic, 54931
Ordinace praktickeho lekare pro deti a dorost
Hradec Králové, Pardubicka 752, Czech Republic, 50004
Ordinace praktickeho lekare pro deti a dorost
Chlumec nad Cidlinou, Pernstynska 127/I, Czech Republic, 50351
Nemocnice Náchod
Nachod, Purkynova 446, Czech Republic, 54701
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, Ruských legií 352, Czech Republic, 37701
Ordinace praktickeho lekare pro deti a dorost
Pardubice, Sladkovskeho 2617, Czech Republic, 53002
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, Sídliste Vajgar 724/III, Czech Republic, 37701
Fakulta vojenskeho zdravotnictvi UO
Hradec Kralove, Trebesska 1575, Czech Republic, 50001
Ordinace praktickeho lekare pro deti a dorost
Holice, U kaplicky 1042, Czech Republic, 53401
Ordinace praktickeho lekare pro deti a dorost
Jindrichuv Hradec, U nemocnice380/III, Czech Republic, 37701
Italy
Universita di Firenze -Pediatria
Florence, Italy, 50139
IRCCS Cà Granda
Milan, Italy, 20122
Ospedale Maggiore della Carita
Novara, Italy, 28100
Dip Pediatria AO Padova
Padova, Italy, 35128
Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela A Coruña, Spain, 15706
Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
Valencia, Spain, 46020/46001
Hospital Universitario Dr. Peset
Valencia, Spain, 46017
Complexo Hospitalario Xeral Cies
Vigo Pontevedra, Spain, 36204
United Kingdom
Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
Oxford, Headington, United Kingdom, OX3 7LJ
North Bristol NHS Trust
Bristol, United Kingdom, BS1 3NU
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
St Georges Hospital
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01717638     History of Changes
Other Study ID Numbers: V72P12E2, 2011-004931-30
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

Keywords provided by Novartis:
Meningococcal disease, vaccines, children, persistence

Additional relevant MeSH terms:
Meningitis, Meningococcal
Meningococcal Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis
Meningitis, Bacterial
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2015