Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02141516 | Safety and Immunogenicity of Novartis Meningococcal B Vaccine When Administered to Immunocompromised Children and Adolescents Compared to Healthy Subjects. | PHASE3 | COMPLETED | 239 | — | — | May 1, 2014 | Mar 1, 2015 | Feb 15, 2017 | 20 | Italy, Poland +3 |
| NCT01339923 | A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years | PHASE3 | COMPLETED | 1,409 | — | — | Apr 1, 2011 | Dec 1, 2014 | May 9, 2016 | 26 | Brazil, Hungary +2 |
| NCT01139021 | One Year Antibody Persistence After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting From 12 Months of Age and Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age | PHASE3 | COMPLETED | 508 | — | — | Jun 1, 2010 | Sep 1, 2011 | Apr 10, 2015 | 19 | Czechia, Finland |
| NCT01026974 | Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received Three Doses of the Same Vaccine | PHASE2 | COMPLETED | 120 | — | — | Feb 1, 2010 | May 1, 2012 | Oct 1, 2014 | 1 | United Kingdom |
| NCT00944034 | Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12 | PHASE2 | COMPLETED | 1,588 | — | — | Jul 1, 2009 | Jan 1, 2012 | Aug 14, 2017 | 72 | Belgium, Czechia +4 |
| NCT00661713 | Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents According to Different Vaccination Schedules | PHASE2 | COMPLETED | 1,631 | — | — | Jun 1, 2008 | Dec 1, 2010 | Mar 20, 2019 | 10 | Chile |
| NCT00433914 | Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants | PHASE2 | COMPLETED | 60 | — | — | Feb 1, 2007 | Jul 1, 2008 | Mar 6, 2015 | 1 | United Kingdom |
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.
Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.
Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.
To assess the immunogenicity in terms of human Serum Bactericidal Assay (hSBA) GMTs through antibody persistence at 12 months after a booster (fourth) dose of Novartis Meningococcal B Recombinant Vaccine (rMenB+OMV NZ) in groups that received a three-dose primary series at 2, 4,6 months of age. Group B246\_12M12 received Measles, Mumps, Rubella, Varicella (MMRV) at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on Modified Intention-To-Treat (MITT) population- (Primary).
To assess the immunogenicity in terms of percentage of subjects with hSBA ≥1:5 and hSBA ≥1:8 through antibody persistence at 12 months after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately). Analysis was done on MITT population (Primary).
To assess the immunogenicity in terms of GMCs determined by Enzyme Linked Immunosorbent Assay (ELISA) through antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ in groups that received a three-dose primary series at 2, 4, 6 months of age. Group B246\_12M12 received MMRV at 12 months of age (concomitantly) and group B246\_12M13 received MMRV at 13 months of age (separately) against vaccine antigen 287-953. Analysis was done on MITT population (Primary).
The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.
The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.
Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.
Immunogenicity was evaluated by measuring the percentage of subjects with hSBA titter \>1:4 against 44/76-SL, 5/99, NZ98/254 strains at months 1, 2, 3.
Safety was assessed as the number of subjects who reported local and systemic reactions during day 1 to day 7 after any vaccination with rMenB+OMV
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age).
Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age).
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Complement deficiency |
| Group B | EXPERIMENTAL | asplenia/splenic dysfunction |
| Group C | ACTIVE_COMPARATOR | age-matched healthy controls |
| B_2h3h5_11 | EXPERIMENTAL | Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. |
| B_3h5_11 | EXPERIMENTAL | Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. |
| B_68_11 | EXPERIMENTAL | Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. |
| B_02_2_5 | EXPERIMENTAL | Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. |
| B_02_6_10 | EXPERIMENTAL | Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start. |
| BC_35_12 | EXPERIMENTAL | Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age. |
| C_35_12 | EXPERIMENTAL | Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age. |
| B246_12_M12 | EXPERIMENTAL | Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age. |
| B246_12M13 | EXPERIMENTAL | Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age. |
| B13_15_27 | EXPERIMENTAL | Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age. |
| B12_14_26 | EXPERIMENTAL | Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age. |
| B_24_26 | EXPERIMENTAL | Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age. |
| B12M13 | EXPERIMENTAL | Subject was randomized in group B13\_15\_27 but treated as group B12\_M13. |
| 4rMenB | EXPERIMENTAL | Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB vaccine at 40 months of age in the present study. |
| 4rMenB+OMV NZ | EXPERIMENTAL | Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study (NCT00433914) and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study. |
| Naive_4042 | EXPERIMENTAL | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
| Naive_6062 | EXPERIMENTAL | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study. |
| B+R246_12 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. |
| B+R246_18 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. |
| B+R246_24 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. |
| B246_12 | EXPERIMENTAL | Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. |
| B246_18 | EXPERIMENTAL | Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. |
| B246_24 | EXPERIMENTAL | Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. |
| B+R234_12 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age. |
| B+R234_18 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. |
| B+R234_24 | EXPERIMENTAL | Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. |
| B12 14 | EXPERIMENTAL | Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age. |
| B18 20 | EXPERIMENTAL | Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age. |
| B24 26 | EXPERIMENTAL | Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age. |
| rMenB06 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and two injections of placebo (at month 1, month 2). A second injection of rMenB+OMV NZ vaccine was given later (month 6). |
| rMenB0 | EXPERIMENTAL | Subjects received one injection of rMenB+OMV NZ vaccine (month 0) and three injections of placebo (month 1, month 2 and month 6). |
| rMenB016 | EXPERIMENTAL | Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). |
| rMenB01 | EXPERIMENTAL | Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 1) and two injection of placebo (at month 2 and month 6). |
| rMenB026 | EXPERIMENTAL | Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and one injection of placebo (at month 2). A third injection of rMenB+OMV NZ vaccine was given later (at month 6). |
| rMenB02 | EXPERIMENTAL | Subjects received two injections of rMenB+OMV NZ vaccine (at month 0 and month 2) and two injections of placebo (at month 1 and month 6). |
| rMenB012 | EXPERIMENTAL | Subjects received three injections of rMenB+OMV NZ vaccine (at month 0, month 1 and month 2) and one injection of placebo later (at month 6). |
| rMenB6 | EXPERIMENTAL | Subjects received three injections of placebo(at month 0, month 1 and month 2) and one injection of rMenB+OMV NZ vaccine(at month 6). |
| rMenB | EXPERIMENTAL | 6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. |
| rMenB+OMV | EXPERIMENTAL | 6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. |
| Name | Type | Description |
|---|---|---|
| rMenB+OMV | BIOLOGICAL | 2 doses of vaccine 2 months apart |
| rMenB + OMV NZ vaccine | BIOLOGICAL | 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age) |
| Meningococcal C oligosaccharide conjugated vaccine | BIOLOGICAL | Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine |
| Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. | BIOLOGICAL | Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. |
| rMenB+OMV NZ | BIOLOGICAL | Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn. |
| rMenB | BIOLOGICAL | - |
| rMenB+OMV NZ with routine vaccinations | BIOLOGICAL | rMenB+OMV NZ with routine vaccinations at 2, 4, and 6 months of age; random allocation in a 1:1:1 ratio to receive a booster dose of rMenB+OMV NZ at 12 months of age |
| two doses of rMenB+OMV NZ | BIOLOGICAL | two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age. |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: Inclusion criterion applicable to All Groups * Subjects aged 2 to 17 years (inclusive) at enrollment * weighing at least 13 Kg at the time of enrollment Inclusion criterion applicable to Group A - Subjects at risk of meningococcal disease because of primary or secondary comple...