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CompletedNCT01717638Updated Jan 13, 2015Results posted

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

A Phase 3 interventional study of 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine and 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in Meningococcal Disease and Meningococcal Meningitis, sponsored by Novartis Vaccines. Completed at 29 sites in 4 countries. Open to participants aged 48 Months to 60 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-13.

Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
805
Allocation
Non-randomized
Ages
48 Months to 60 Months
Sex
All
01

Study summary

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.

02

Conditions studied

  • Meningococcal Disease
  • Meningococcal Meningitis

Keywords

  • Meningococcal disease, vaccines, children, persistence
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 805 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Months to 60 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
805 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Biological1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine

    0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose

    Also known as: rMenB+OMV NZ

  • Biological2 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

    Also known as: rMenB+OMV NZ

06

What researchers measure

Primary outcomes

  1. 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

    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).

    Time frame: Day 1 (24-36 months post booster; baseline for naive)

  2. 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

    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).

    Time frame: Day 1 (24-36 months post booster; baseline for naive)

  3. 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

    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.

    Time frame: Day 1 (24-36 months post booster dose; baseline for naive)

Secondary outcomes

  1. 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

    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.

    Time frame: Day 1 (22-34 months post last MenB vaccine)

  2. 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

    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.

    Time frame: Day 1 (22-36 months post last MenB vaccine; baseline for naive)

  3. 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

    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.

    Time frame: Day 1 (22-34 months post last MenB vaccine)

  4. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  5. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  6. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  7. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  8. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  9. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  10. 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.

    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.

    Time frame: Day 31 (1 month post vaccination)

  11. 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

    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.

    Time frame: Day 31 (1 month post vaccination)

  12. 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.

    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.

    Time frame: Day 91 (1 month post second vaccination)

  13. GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

    The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

    Time frame: Day 91 (1 month post second vaccination)

  14. GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

    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.

    Time frame: Day 91 (1 month post second vaccination)

  15. 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

    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.

    Time frame: Day 91 (1 month post second vaccination)

  16. 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)

    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.

    Time frame: From day 1 to day 7 after vaccination

  17. 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)

    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.

    Time frame: From day 1 to day 7 after vaccination

  18. 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

    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.

    Time frame: From day 1 to day 7 after any vaccination

  19. Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

    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.

    Time frame: From day 1 to study termination

  20. Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

    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.

    Time frame: From day 1 to study termination

  21. Number of Subjects Reporting Unsolicited AEs After Any Vaccination.

    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.

    Time frame: From day 1 to study termination

07

Results

Posted Jan 13, 2015

Participant flow

Subjects were enrolled from 4 centers from the UK, 4 centers from Italy, 4 centers from Spain, 19 centers from Czech Republic.

Participant flow — Overall Study
MilestoneB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B12 14_48B18 20_48B24 26_48B48_50
Started6761606664554329281001112209
Completed676059666354412826991112190
Not completed01101121210019
Withdrew: Lost to follow-up0000010000000
Withdrew: Father in hospital0000000000001
Withdrew: Withdrawal by subject01101021210018

Outcome measures

PrimaryPercentages 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

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).

Time frame:
Day 1 (24-36 months post booster; baseline for naive)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76 - ≥1:5; N=67,60,59,65,63,54,42,28,28,20612 (5 to 22)18 (10 to 30)24 (14 to 37)20 (11 to 32)27 (17 to 40)35 (23 to 49)12 (4 to 26)25 (11 to 45)21 (8 to 41)0 (0 to 3)
5/99 - ≥1:5; N=67,60,58,64,62,54,42,28,28,20093 (83 to 98)98 (91 to 100)97 (88 to 100)97 (89 to 100)100 (94 to 100)100 (93 to 100)90 (77 to 97)89 (72 to 98)96 (82 to 100)5 (2 to 8)
NZ 98/254 - ≥ 1:59 (3 to 18)8 (3 to 18)12 (5 to 23)9 (3 to 19)11 (5 to 22)9 (3 to 20)10 (3 to 23)11 (2 to 28)11 (2 to 28)0 (0 to 3)
M10713 - ≥1:5; N=65,59,58,62,60,54,40,28,28,19254 (41 to 66)68 (54 to 79)74 (61 to 85)55 (42 to 68)53 (40 to 66)80 (66 to 89)68 (51 to 81)75 (55 to 89)75 (55 to 89)60 (53 to 67)
H44/76-≥1:8; N=67,60,59,65,63,54,42,28,28,2067 (2 to 17)10 (4 to 21)17 (8 to 29)11 (4 to 21)24 (14 to 36)28 (16 to 42)7 (1 to 19)21 (8 to 41)21 (8 to 41)0 (0 to 3)
5/99 - ≥1:8; N=67,60,58,64,62,54,42,28,28,20091 (82 to 97)97 (88 to 100)93 (83 to 98)94 (85 to 98)94 (84 to 98)100 (93 to 100)90 (77 to 97)86 (67 to 96)96 (82 to 100)3 (1 to 6)
NZ 98/254 - ≥ 1:84 (1 to 13)5 (1 to 14)8 (3 to 18)8 (3 to 17)3 (0 to 11)4 (0 to 13)2 (0.06 to 13)7 (1 to 24)11 (2 to 28)0 (0 to 3)
M10713 - ≥1:8; N=65,59,58,62,60,54,40,28,28,19249 (37 to 62)53 (39 to 66)60 (47 to 73)48 (35 to 61)45 (32 to 58)65 (51 to 77)60 (43 to 75)61 (41 to 78)61 (41 to 78)56 (48 to 63)
PrimaryPersisting 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

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).

Time frame:
Day 1 (24-36 months post booster; baseline for naive)
Reported as:
Geometric mean · Titers
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
TitersB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76; N=67,60,59,65,63,54,42,28,28,2061.75 (1.36 to 2.25)1.68 (1.29 to 2.19)2.41 (1.83 to 3.19)1.72 (1.29 to 2.29)1.99 (1.49 to 2.65)2.69 (1.96 to 3.7)1.51 (1.04 to 2.18)2.2 (1.38 to 3.49)2.2 (1.37 to 3.53)1.04 (1.01 to 1.07)
5/99; N=67,60,58,64,62,54,42,28,28,20036 (27 to 48)69 (50 to 94)69 (50 to 96)59 (45 to 78)57 (43 to 75)111 (82 to 151)52 (34 to 81)62 (36 to 108)101 (57 to 177)1.15 (1.05 to 1.27)
NZ 98/2541.25 (1.03 to 1.52)1.29 (1.05 to 1.59)1.38 (1.11 to 1.72)1.48 (1.2 to 1.83)1.34 (1.08 to 1.66)1.52 (1.2 to 1.92)1.32 (1.05 to 1.65)1.25 (0.94 to 1.66)1.62 (1.21 to 2.16)1.01 (0.99 to 1.03)
M10713; N=65,59,58,62,60,54,40,28,28,1926.14 (4.19 to 8.99)7.36 (4.94 to 11)9.08 (5.97 to 14)7.86 (5.17 to 12)7.77 (5.07 to 12)15 (9.49 to 24)9.61 (5.81 to 16)11 (5.92 to 20)11 (5.9 to 21)8.75 (6.74 to 11)
PrimaryGeometric 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

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.

Time frame:
Day 1 (24-36 months post booster dose; baseline for naive)
Reported as:
Geometric mean · Ratio
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
RatioB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48
H44/76; N=62,56,52,57,55,46,38,27,25,2060.012 (0.0091 to 0.017)0.013 (0.0096 to 0.018)0.023 (0.016 to 0.033)0.0092 (0.0066 to 0.013)0.013 (0.0097 to 0.018)0.023 (0.016 to 0.033)0.0091 (0.0064 to 0.013)0.023 (0.015 to 0.036)0.023 (0.014 to 0.036)
5/99; N=61,57,50,57,55,44,37,27,25,2000.029 (0.023 to 0.037)0.032 (0.026 to 0.041)0.043 (0.033 to 0.056)0.031 (0.024 to 0.041)0.034 (0.026 to 0.045)0.054 (0.04 to 0.074)0.035 (0.026 to 0.048)0.037 (0.025 to 0.054)0.055 (0.037 to 0.081)
NZ 98/2540.028 (0.021 to 0.039)0.094 (0.067 to 0.13)0.071 (0.05 to 0.1)0.043 (0.031 to 0.06)0.081 (0.058 to 0.11)0.11 (0.075 to 0.16)0.03 (0.02 to 0.044)0.082 (0.05 to 0.14)0.066 (0.038 to 0.11)
M10713; N=26,24,25NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)0.67 (0.32 to 1.4)0.91 (0.4 to 2.05)0.47 (0.21 to 1.07)
SecondaryPercentages 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

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.

Time frame:
Day 1 (22-34 months post last MenB vaccine)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB12 14_48B18 20_48B24 26_48B48 50
hSBA≥ 1:5 (H44/76 strain)11 (6 to 20)9 (0 to 41)9 (0 to 41)0 (0 to 3)
hSBA≥ 1:5 (5/99 strain; N=96,11,11,200)84 (76 to 91)100 (72 to 100)100 (72 to 100)5 (2 to 8)
hSBA≥ 1:5 (NZ 98/254 strain)3 (1 to 9)18 (2 to 52)0 (0 to 28)0 (0 to 3)
hSBA≥ 1:5 (M10713 strain; N=96,10,10,192)59 (49 to 69)60 (26 to 88)60 (26 to 88)60 (53 to 67)
hSBA≥ 1:8 (H44/76 strain)8 (4 to 16)9 (0 to 41)0 (0 to 28)0 (0 to 3)
hSBA≥ 1:8 (5/99 strain; N=96,11,11,200)81 (72 to 88)100 (72 to 100)100 (72 to 100)3 (1 to 6)
hSBA≥ 1:8 (NZ 98/254 strain)2 (0 to 7)18 (2 to 52)0 (0 to 28)0 (0 to 3)
hSBA≥ 1:8 (M10713 strain; N=96,10,10,192)49 (39 to 59)40 (12 to 74)60 (26 to 88)56 (48 to 63)
SecondaryPersisting 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

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.

Time frame:
Day 1 (22-36 months post last MenB vaccine; baseline for naive)
Reported as:
Geometric mean · Titers
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
TitersB12 14_48B18 20_48B24 26_48B48 50
H44/76 strain1.61 (1.3 to 2)2.03 (1.11 to 3.72)1.69 (0.91 to 3.12)1.04 (1.01 to 1.07)
5/99 strain; N=96, 11, 11, 20023 (17 to 32)47 (20 to 112)69 (29 to 165)1.15 (1.05 to 1.27)
NZ 98/254 strain1.15 (0.96 to 1.37)2.68 (1.65 to 4.36)1.06 (0.65 to 1.75)1.01 (0.99 to 1.03)
M10713 strain; N=96, 10, 10, 1927.83 (5.54 to 11)9.67 (3.54 to 26)8.4 (3.03 to 23)8.75 (6.74 to 11)
SecondaryGMRs 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

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.

Time frame:
Day 1 (22-34 months post last MenB vaccine)
Reported as:
Geometric mean · Ratio
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
RatioB12 14_48B18 20_48B24 26_48
H44/76 strain0.092 (0.069 to 0.12)0.18 (0.078 to 0.43)0.2 (0.086 to 0.45)
5/99 strain0.45 (0.34 to 0.59)1.9 (0.84 to 4.29)1.36 (0.62 to 3)
NZ 98/254 strain; N=88, 9, 80.28 (0.21 to 0.37)0.73 (0.32 to 1.68)0.42 (0.17 to 1.01)
M10713 strain; N=7, 7, 811 (3.34 to 38)6.05 (1.45 to 25)6.88 (1.68 to 28)
SecondaryPercentages 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76 - ≥1:5; N=26,18,16,16,26,15,39,26,26,175100 (87 to 100)100 (81 to 100)100 (79 to 100)100 (79 to 100)100 (87 to 100)100 (78 to 100)97 (87 to 100)100 (87 to 100)100 (87 to 100)71 (64 to 78)
5/99 - ≥1:5; N=26,18,16,16,26,15,38,26,26,171100 (87 to 100)100 (81 to 100)100 (79 to 100)100 (79 to 100)100 (87 to 100)100 (78 to 100)100 (91 to 100)100 (87 to 100)100 (87 to 100)90 (85 to 94)
NZ 98/254 - ≥1:5; N=26,18,16,16,26,15,40,26,26,17392 (75 to 99)83 (59 to 96)94 (70 to 100)81 (54 to 96)88 (70 to 98)80 (52 to 96)95 (83 to 99)92 (75 to 99)92 (75 to 99)24 (18 to 31)
M10713 - ≥1:5; N=25,18,16,14,25,15,36,25,25,16784 (64 to 95)89 (65 to 99)88 (62 to 98)93 (66 to 100)96 (80 to 100)93 (68 to 100)97 (85 to 100)100 (86 to 100)100 (86 to 100)77 (70 to 83)
H44/76 - ≥1:8; N=26,18,16,16,26,15,39,26,26,17596 (80 to 100)100 (81 to 100)100 (79 to 100)100 (79 to 100)96 (80 to 100)100 (78 to 100)97 (87 to 100)100 (87 to 100)96 (80 to 100)63 (55 to 70)
5/99 - ≥1:8; N=26,18,16,16,26,15,38,26,26,171100 (87 to 100)100 (81 to 100)100 (79 to 100)100 (79 to 100)100 (87 to 100)100 (78 to 100)100 (91 to 100)100 (87 to 100)100 (87 to 100)87 (81 to 92)
NZ 98/254 - ≥1:8; N=26,18,16,16,26,15,40,26,26,17385 (65 to 96)61 (36 to 83)81 (54 to 96)75 (48 to 93)88 (70 to 98)80 (52 to 96)88 (73 to 96)81 (61 to 93)88 (70 to 98)17 (12 to 24)
M10713 - ≥1:8; N=25,18,16,14,25,15,36,25,25,16776 (55 to 91)89 (65 to 99)88 (62 to 98)93 (66 to 100)96 (80 to 100)93 (68 to 100)97 (85 to 100)100 (86 to 100)96 (80 to 100)74 (67 to 81)
SecondaryGMTs 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Geometric mean · Titers
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
TitersB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76 strain; N=26,18,16,16,26,15,39,26,26,175108 (70 to 168)115 (68 to 195)107 (61 to 188)173 (98 to 303)191 (123 to 297)212 (119 to 379)167 (109 to 258)146 (85 to 251)135 (78 to 235)11 (8.51 to 14)
5/99 strain; N=26,18,16,16,26,15,38,26,26,171754 (478 to 1190)1719 (993 to 2976)933 (518 to 1682)1959 (1091 to 3517)1387 (878 to 2191)1954 (1068 to 3575)1711 (1186 to 2470)1239 (787 to 1953)1280 (803 to 2041)34 (27 to 42)
NZ 98/254 strain; N=26,18,16,16,26,15,40,26,26,17322 (13 to 36)11 (5.66 to 20)28 (14 to 55)16 (8.2 to 31)21 (13 to 36)15 (7.66 to 31)26 (18 to 36)18 (12 to 28)27 (18 to 42)2.25 (1.84 to 2.75)
M10713 strain; N=25,18,16,14,25,15,36,25,25,16722 (13 to 37)19 (10 to 36)28 (14 to 54)32 (16 to 65)37 (22 to 63)33 (17 to 64)53 (40 to 71)58 (40 to 84)51 (35 to 73)20 (15 to 25)
SecondaryGeometric 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Geometric mean · Ratio
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
RatioB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76 strain; N=26,18,16,16,26,15,39,25,26,17560 (40 to 92)72 (44 to 120)41 (24 to 71)77 (45 to 132)88 (58 to 134)46 (26 to 80)109 (71 to 167)63 (37 to 108)64 (37 to 110)10 (8.2 to 13)
5/99 strain; N=26,18,16,15,25,15,38,25,26,16832 (22 to 47)23 (15 to 36)15 (9.45 to 25)30 (18 to 49)20 (13 to 29)18 (11 to 29)33 (23 to 49)20 (12 to 32)12 (7.16 to 19)29 (23 to 37)
NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,17317 (10 to 29)10 (5.43 to 19)19 (9.54 to 37)8.93 (4.57 to 17)17 (10 to 29)13 (6.48 to 26)19 (14 to 27)14 (9.35 to 22)17 (11 to 26)2.25 (1.84 to 2.75)
M10713 strain; N=24,17,16,12,23,15,35,24,25,1583.15 (1.81 to 5.48)4.46 (2.31 to 8.6)3.36 (1.69 to 6.7)3.49 (1.58 to 7.7)3.74 (2.12 to 6.59)4.21 (2.08 to 8.51)5.35 (3.48 to 8.21)3.86 (2.23 to 6.66)4.04 (2.35 to 6.94)2 (1.62 to 2.46)
SecondaryPercentages 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B48 50
H44/76 strain; N=26,18,16,16,26,15,39,25,26,17592 (75 to 99)100 (81 to 100)100 (79 to 100)100 (79 to 100)96 (80 to 100)93 (68 to 100)97 (87 to 100)96 (80 to 100)96 (80 to 100)63 (55 to 70)
5/99 strain; N=26,18,16,15,25,15,38,25,26,16896 (80 to 100)94 (73 to 100)94 (70 to 100)100 (78 to 100)92 (74 to 99)100 (78 to 100)97 (86 to 100)96 (80 to 100)85 (65 to 96)86 (80 to 91)
NZ 98/254 strain; N=26,18,16,16,26,15,40,25,26,17381 (61 to 93)61 (36 to 83)81 (54 to 96)69 (41 to 89)88 (70 to 98)73 (45 to 92)88 (73 to 96)72 (51 to 88)85 (65 to 96)17 (12 to 24)
M10713 strain; N=24,17,16,12,23,15,35,24,25,15838 (19 to 59)47 (23 to 72)31 (11 to 59)33 (10 to 65)39 (20 to 61)40 (16 to 68)49 (31 to 66)46 (26 to 67)32 (15 to 54)21 (15 to 28)
SecondaryPercentages 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB12 14_48B18 20_48B24 26_48B48_50
hSBA≥ 1:5 (H44/76 strain)100 (96 to 100)100 (69 to 100)100 (74 to 100)71 (64 to 78)
hSBA≥ 1:5 (5/99 strain; N=95,10,12,171)100 (96 to 100)100 (69 to 100)100 (74 to 100)90 (85 to 94)
hSBA≥ 1:5 (NZ 98/254 strain; N=95,10,12,173)96 (90 to 99)70 (35 to 93)100 (74 to 100)24 (18 to 31)
hSBA≥ 1:5 (M10713 strain; N=90,9,10,167)93 (86 to 98)100 (66 to 100)90 (55 to 100)77 (70 to 83)
hSBA≥ 1:8 (H44/76 strain)100 (96 to 100)100 (69 to 100)100 (74 to 100)63 (55 to 70)
hSBA≥ 1:8 (5/99 strain; N=94,10,12,171)100 (96 to 100)100 (69 to 100)100 (74 to 100)87 (81 to 92)
hSBA≥ 1:8 (NZ 98/254 strain; N=95,10,12,173)95 (88 to 98)60 (26 to 88)100 (74 to 100)17 (12 to 24)
hSBA≥ 1:8 (M10713 strain; N=90,9,10,167)92 (85 to 97)100 (66 to 100)90 (55 to 100)74 (67 to 81)
SecondaryGMTs 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Geometric mean · Titers
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
TitersB12 14_48B18 20_48B24 26_48B48 50
H44/76 strain154 (124 to 191)145 (76 to 277)211 (116 to 383)11 (8.51 to 14)
5/99 strain; N= 94,10,12,1711575 (1219 to 2034)2381 (1112 to 5095)3604 (1785 to 7278)34 (27 to 42)
NZ 98/254 strain; N=95,10,12,17331 (25 to 39)18 (8.87 to 35)47 (25 to 88)2.25 (1.84 to 2.75)
M10713 strain; N=90,9,10,16738 (29 to 49)74 (34 to 164)84 (39 to 180)20 (15 to 25)
SecondaryGMRs 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.

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Geometric mean · Ratio
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.
RatioB12 14_48B18 20_48B24 26_48B48 50
H44/76 strain99 (79 to 125)67 (34 to 135)133 (68 to 258)10 (8.2 to 13)
5/99 strain; N=92,10,11,16870 (57 to 86)51 (27 to 95)55 (30 to 99)29 (23 to 37)
NZ 98/254 strain; N=93,10,11,17327 (21 to 36)5.96 (2.7 to 13)38 (18 to 81)2.25 (1.84 to 2.75)
M10713 strain; N=88,9,9,1585.24 (3.91 to 7.02)7.06 (2.92 to 17)7.35 (3.03 to 18)2 (1.62 to 2.46)
SecondaryPercentages 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

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.

Time frame:
Day 31 (1 month post vaccination)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB12 14_48B18 20_48B24 26_48B48 50
H44/76 strain99 (94 to 100)90 (55 to 100)100 (72 to 100)63 (55 to 70)
5/99 strain; N=92,10,11,168100 (96 to 100)90 (55 to 100)100 (72 to 100)86 (80 to 91)
NZ 98/254 strain; N=93,10,11,17394 (86 to 98)50 (19 to 81)100 (72 to 100)17 (12 to 24)
M10713 strain; N=88,9,9,15858 (47 to 68)67 (30 to 93)56 (21 to 86)21 (15 to 28)
SecondaryPercentages 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.

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.

Time frame:
Day 91 (1 month post second vaccination)
Reported as:
Number · Percentages of subjects
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.
Percentages of subjectsB48_50
hSBA≥ 1:5 (H44/76 strain)100 (98 to 100)
hSBA≥ 1:5 (5/99 strain)100 (98 to 100)
hSBA≥ 1:5 (NZ 98/254 strain; N=174)91 (85 to 95)
hSBA≥ 1:8 (H44/76 strain)100 (98 to 100)
hSBA≥ 1:8 (5/99 strain)100 (98 to 100)
hSBA≥ 1:8 (NZ 98/254 strain; N=174)80 (73 to 86)
SecondaryGMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.

Time frame:
Day 91 (1 month post second vaccination)
Reported as:
Geometric mean · Titers
GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
TitersB48 50
H44/76 strain109 (98 to 120)
5/99 strain343 (302 to 389)
NZ 98/254 strain; N=17417 (14 to 19)
M10713 strain; N=17147 (40 to 56)
SecondaryGMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age

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.

Time frame:
Day 91 (1 month post second vaccination)
Reported as:
Geometric mean · Ratio
GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age
RatioB48 50
H44/76 strain105 (94 to 116)
5/99 strain; N=172299 (256 to 350)
NZ 98/254 strain; N=17417 (14 to 19)
M10713 strain; N=1715.12 (3.95 to 6.65)
SecondaryPercentages 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

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.

Time frame:
Day 91 (1 month post second vaccination)
Reported as:
Number · Percentages of subjects
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
Percentages of subjectsB48 50
H44/76 strain100 (98 to 100)
5/99 strain; N=17299 (97 to 100)
NZ 98/254 strain; N=17480 (73 to 86)
M10713 strain; N=16151 (43 to 59)
SecondaryNumber of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

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.

Time frame:
From day 1 to day 7 after vaccination
Reported as:
Number · Number of subjects
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)
Number of subjectsB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48
Any local271817162417382827
Injection site Pain (mild)451652467
Injection site Pain (moderate)189134149241417
Injection site Pain (severe)5436451083
Injection site Erythema (25 - 50 mm)233563565
Injection site Erythema (51 - 100 mm)5212731063
Injection site Erythema (>100 mm)100011200
Injection site Induration (25 - 50 mm)221252676
Injection site Induration (51 - 100 mm)100121211
Injection site Induration (>100 mm)100001100
Injection site Swelling (25 - 50 mm)133453774
Injection site Swelling (51 - 100 mm)101232751
Injection site Swelling (>100 mm)100001100
Any Systemic261514181913362723
Change in eating habits12661278201113
Rash210524752
Arthralagia124698511812
Headache516323758
Irritability1891114138232016
Diarrhea411242643
Vomiting010010532
Fever (≥ 38.0 °C)633211542
Antipyretic used (prophylactically)121121711
Antipyretic used (therapeutically)5543311043
SecondaryNumber of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

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.

Time frame:
From day 1 to day 7 after vaccination
Reported as:
Number · Number of subjects
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)
Number of subjectsB12 14_48B18 20_48B24 26_48
Any local94911
Injection site Pain (mild)3322
Injection site Pain (moderate)4268
Injection site Pain (severe)1911
Injection site Erythema (25 - 50 mm)1220
Injection site Erythema (51 - 100 mm)710
Injection site Erythema (>100 mm)200
Injection site Induration (25 - 50 mm)810
Injection site Induration (51 - 100 mm)000
Injection site Induration (>100 mm)100
Injection site Swelling (25 - 50 mm)1823
Injection site Swelling (51 - 100 mm)201
Injection site Swelling (>100 mm)000
Any Systemic7869
Change in eating habits4203
Rash1300
Arthralagia2816
Headache2024
Irritability5345
Diarrhea502
Vomiting621
Fever (≥ 38.0 °C)1645
Antipyretic used (prophylactically)522
Antipyretic used (therapeutically)1845
SecondaryNumber 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

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.

Time frame:
From day 1 to day 7 after any vaccination
Reported as:
Number · Number of subjects
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
Number of subjectsB48 50 (After 1st Dose)B48 50 (After 2nd Dose)
Any local186161
Injection site Pain (mild)8170
Injection site Pain (moderate)7766
Injection site Pain (severe)2721
Injection site Erythema (25 - 50 mm; N= 204, 194)3415
Injection site Erythema (51 - 100 mm; N= 204, 194)819
Injection site Erythema (>100 mm; N= 204, 194)10
Injection site Induration (25 - 50 mm; N= 204, 1942316
Injection site Induration (51-100 mm; N= 204, 194)34
Injection site Induration(>100 mm; N= 204, 19400
Injection site Swelling (25 - 50 mm; N= 204, 1942620
Injection site Swelling (51 - 100 mm; N= 204, 194)34
Injection site Swelling (>100 mm; N= 204, 194)10
Any Systemic137108
Rash; N=201, 1921510
Change in eating habits; N= 203, 1944943
Headache; N= 204, 1942524
Arthralagia; N= 203, 1924540
Irritability; N= 204, 1936758
Vomiting86
Diarrhea; N= 204, 193118
Fever (≥ 38.0 °C; N= 204, 189)2016
Antipyretic used (prophylactically; N= 204, 193)1723
Antipyretic used (therapeutically; N= 204, 193)2224
SecondaryNumber of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

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.

Time frame:
From day 1 to study termination
Reported as:
Number · Number of subjects
Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Number of subjectsB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48
Any AEs84477311116
SAEs000000000
AEs leading to withdrawal000000000
SecondaryNumber of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)

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.

Time frame:
From day 1 to study termination
Reported as:
Number · Number of subjects
Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)
Number of subjectsB12 14_48B18 20_48B24 26_48
Any AE2524
SAEs000
AEs leading to withdrawal000
SecondaryNumber of Subjects Reporting Unsolicited AEs After Any Vaccination.

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.

Time frame:
From day 1 to study termination
Reported as:
Number · Number of participants
Number of Subjects Reporting Unsolicited AEs After Any Vaccination.
Number of participantsB48 50
Any AEs105
SAEs3
AEs leading to premature withdrawal1

Adverse events

Collected over Solicited local and systemic AEs, medically attended fever, use of antipyretics and all AEs were recorded for 7 days after vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were recorded throughout the study period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
B+R246_12_48—0/30 (0%)29/30 (96.7%)
B+R246_18_48—0/20 (0%)19/20 (95%)
B+R246_24_48—0/17 (0%)17/17 (100%)
B246_12_48—0/19 (0%)18/19 (94.7%)
B246_18_48—0/27 (0%)25/27 (92.6%)
B246_24_48—0/17 (0%)17/17 (100%)
B+R234_12_48—0/43 (0%)42/43 (97.7%)
B+R234_18_48—0/29 (0%)28/29 (96.6%)
B+R234_24_48—0/28 (0%)27/28 (96.4%)
B12 14_48—0/100 (0%)97/100 (97%)
B18 20_48—0/11 (0%)10/11 (90.9%)
B24 26_48—0/12 (0%)12/12 (100%)
B48 50—3/206 (1.5%)200/206 (97.1%)
Most frequent serious events
Most frequent serious events
EventB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B12 14_48B18 20_48B24 26_48B48 50
CROUP INFECTIOUSInfections and infestations0/300/200/170/190/270/170/430/290/280/1000/110/121/206
GASTROENTERITISInfections and infestations0/300/200/170/190/270/170/430/290/280/1000/110/121/206
CONCUSSIONInjury, poisoning and procedural complications0/300/200/170/190/270/170/430/290/280/1000/110/121/206
CONTUSIONInjury, poisoning and procedural complications0/300/200/170/190/270/170/430/290/280/1000/110/121/206
PERIORBITAL HAEMATOMAInjury, poisoning and procedural complications0/300/200/170/190/270/170/430/290/280/1000/110/121/206
DEHYDRATIONMetabolism and nutrition disorders0/300/200/170/190/270/170/430/290/280/1000/110/121/206
Most frequent other events
Showing 10 of 24
Most frequent other events
EventB+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B12 14_48B18 20_48B24 26_48B48 50
INJECTION SITE PAINGeneral disorders27/3019/2017/1716/1923/2716/1738/4328/2927/2894/1009/1111/12192/206
INJECTION SITE ERYTHEMAGeneral disorders23/3013/2013/1716/1921/2714/1738/4324/2923/2873/1008/117/12166/206
INJECTION SITE INDURATIONGeneral disorders21/308/2011/1714/1911/2712/1724/4321/2919/2846/1006/114/12117/206
IRRITABILITYPsychiatric disorders18/309/2011/1714/1913/278/1723/4320/2916/2853/1004/115/1291/206
SOMNOLENCENervous system disorders18/307/208/179/1912/276/1722/4321/2914/2852/1003/113/12105/206
INJECTION SITE SWELLINGGeneral disorders12/307/2010/1713/1910/2711/1725/4317/2914/2846/1006/117/1296/206
EATING DISORDERPsychiatric disorders12/306/206/1712/197/278/1720/4311/2913/2842/1000/113/1275/206
ARTHRALGIAMusculoskeletal and connective tissue disorders12/304/206/179/198/275/1711/438/2912/2828/1001/116/1267/206
PYREXIAGeneral disorders7/303/203/172/191/271/177/434/292/2819/1005/115/1236/206
HEADACHENervous system disorders5/301/206/173/192/273/177/435/298/2820/1002/114/1240/206

Baseline characteristics

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

Age, Continuous
Age, Continuous(Months)B+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B12 14_48B18 20_48B24 26_48B48 50Total
Mean51.8 ± 3.452.1 ± 3.451.7 ± 3.551.7 ± 3.551.3 ± 3.752.3 ± 3.751.8 ± 3.451.4 ± 3.453.1 ± 3.551.7 ± 3.353.4 ± 4.356.8 ± 1.553.7 ± 3.652.4 ± 3.6
Sex: Female, Male
Sex: Female, Male(Participants)B+R246_12_48B+R246_18_48B+R246_24_48B246_12_48B246_18_48B246_24_48B+R234_12_48B+R234_18_48B+R234_24_48B12 14_48B18 20_48B24 26_48B48 50Total
Female232833283230241713506499387
Male4433273832251912155058110418
08

Study locations

29 sites
  • Ordinace praktickeho lekare pro deti a dorost
    Jaromer, Alšova 466 55101, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Jaromer, Dr. E.Beneše 191 55101, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Sezemice, Havlickova 168 53304, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Hronov, Hostovského 485 54931, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Ceska Skalice, Husovo namesti 36 55203, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Pardubice, L.Male 656 53012, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Hradec Králové, Manesova 646 50002, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Hronov, Palackeho 517 54931, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Hradec Králové, Pardubicka 752 50004, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Chlumec nad Cidlinou, Pernstynska 127/I 50351, Czech Republic
  • Nemocnice Náchod
    Nachod, Purkynova 446 54701, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Jindrichuv Hradec, Ruských legií 352 37701, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Pardubice, Sladkovskeho 2617 53002, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Jindrichuv Hradec, Sídliste Vajgar 724/III 37701, Czech Republic
  • Fakulta vojenskeho zdravotnictvi UO
    Hradec Kralove, Trebesska 1575 50001, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Holice, U kaplicky 1042 53401, Czech Republic
  • Ordinace praktickeho lekare pro deti a dorost
    Jindrichuv Hradec, U nemocnice380/III 37701, Czech Republic
  • Universita di Firenze -Pediatria
    Florence, 50139, Italy
  • IRCCS Cà Granda
    Milan, 20122, Italy
  • Ospedale Maggiore della Carita
    Novara, 28100, Italy
  • Dip Pediatria AO Padova
    Padova, 35128, Italy
  • Hospital Clinico Universitario de Santiago de Compostela
    Santiago de Compostela A Coruña, 15706, Spain
  • Hospital Universitario Dr. Peset
    Valencia, 46017, Spain
  • Centro Superior de Investigacion en Salud Publica/Clinica Universitaria San Vicente Martir
    Valencia, 46020/46001, Spain
  • Complexo Hospitalario Xeral Cies
    Vigo Pontevedra, 36204, Spain
  • Oxford Vaccine Group - Centre for Clinical Vaccinology and Tropical Medicine Churchill Hospital
    Oxford, Headington OX3 7LJ, United Kingdom
  • North Bristol NHS Trust
    Bristol, BS1 3NU, United Kingdom
  • Royal Devon and Exeter NHS Foundation Trust
    Exeter, EX2 5DW, United Kingdom
  • St Georges Hospital
    London, SW17 0RE, United Kingdom
09

References and documents

Publications

  • Sadarangani M, Sell T, Iro MA, Snape MD, Voysey M, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, Odueyungbo A, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of immunity after vaccination with a capsular group B meningococcal vaccine in 3 different toddler schedules. CMAJ. 2017 Oct 16;189(41):E1276-E1285. doi: 10.1503/cmaj.161288. PubMed 29038320 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01717638
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Oct 30, 2012
Start date
Nov 2012
Primary completion
Sep 2013
Completion
Oct 2013
Results posted
Jan 13, 2015
Last update
Jan 13, 2015

Study contacts

Novartis Vaccines
study chair · Novartis Vaccines

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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