Meningococcal Disease
Conditions
Keywords
toddler, Meningococcal disease, prevention, vaccination
Brief summary
The proposed study is an Extension Study of V72P13 to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers
Interventions
BIOLOGICAL1a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and routine vaccine at study month 12.
BIOLOGICAL1b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine at study month 12 and routine vaccine at study month 13.
BIOLOGICAL2a - Routine and rMenB+OMV NZ vaccines
One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15.
BIOLOGICAL2b - rMenB+OMV NZ and routine vaccines
Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12.
BIOLOGICAL3a - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
BIOLOGICAL3b - 1 dose of rMenB+OMV NZ plus routine infant vaccinations
One dose of rMenB vaccine at study month 12 and one dose of routine vaccine study month 13.
BIOLOGICAL4a- rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
BIOLOGICAL4b - rMenB+OMV NZ and routine vaccines
One dose of rMenB vaccine and one dose of routine vaccine at study month 12.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
365 Days to 394 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy 12-month-old toddlers (0/ +29 days) who completed Study V72P13
Exclusion criteria
* Previous ascertained or suspected disease caused by N. meningitidis; * History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * Any serious chronic or progressive disease * Known or suspected impairment/ alteration of the immune system, * Receipt of, or intent to immunize with another vaccine, within 30 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | one month after the booster (fourth) dose | Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | one month after booster (fourth) vaccination. | The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs). |
| Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | one month after third vaccination and pre dose fourth (booster) vaccination | The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. |
| Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | One month post vaccination and pe-booster (fourth) dose vaccination | Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99. |
| Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | one month after booster (fourth) dose vaccination and pre-fourth dose vaccination | The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine. |
| SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | One month after the second dose. | The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose. |
| Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | One month after the second dose. | The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose. |
| Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | one month after booster (fourth) dose | Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone. The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection. |
| ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | One month after the first dose and one month after the second dose. | The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers. |
| Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months | One month after the fourth (booster) dose. | The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b). |
| Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | From day 1 to day 7 after each rMenB+OMV NZ vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M. |
| Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | From day 1 to day 7 after each rMenB+MV NZ vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B). |
| Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | From day 1 to day 7 after MMRV vaccination. | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M. |
| Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | From day 8 to day 28 after MMRV vaccination. | Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M. |
| ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months | One month after the fourth (booster) dose. | The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b). |
Countries
Austria, Czechia, Finland, Germany, Italy
Participant flow
Recruitment details
Subjects were enrolled at 15 sites in Finland, 12 sites in Germany, 5 sites in Austria, 27 sites in Czech Republic and 6 sites in Italy.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 12B12M (1a) Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. | 629 |
| 12B13M (1b) Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study. | 633 |
| 12M13B15B (2a) Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study. | 285 |
| 12M12B14B (2b) Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study. | 117 |
| 12B12M (3a) Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. | 137 |
| 12B13M (3b) Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study. | 156 |
| 12B12M_C (4a) Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study. | 152 |
| 12B13M_C (4b) Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study. | 140 |
| Total | 2,249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | AE or Death | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Inappropriate enrollment | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 | 0 | 4 | 4 | 8 | 2 |
| Overall Study | Protocol Violation | 0 | 0 | 3 | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 6 | 1 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 12B12M (1a) | 12B13M (1b) | 12M13B15B (2a) | 12M12B14B (2b) | 12B12M (3a) | 12B13M (3b) | 12B12M_C (4a) | 12B13M_C (4b) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 12.3 years STANDARD_DEVIATION 0.5 | 12.3 years STANDARD_DEVIATION 0.5 | 12.3 years STANDARD_DEVIATION 0.5 | 12.3 years STANDARD_DEVIATION 0.5 | 12.2 years STANDARD_DEVIATION 0.5 | 12.2 years STANDARD_DEVIATION 0.4 | 12.2 years STANDARD_DEVIATION 0.5 | 12.2 years STANDARD_DEVIATION 0.4 | 12.3 years STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 290 Participants | 330 Participants | 131 Participants | 55 Participants | 75 Participants | 81 Participants | 62 Participants | 73 Participants | 1097 Participants |
| Sex: Female, Male Male | 339 Participants | 303 Participants | 154 Participants | 62 Participants | 62 Participants | 75 Participants | 90 Participants | 67 Participants | 1152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 754 / 765 | 760 / 789 | 282 / 284 | 116 / 117 | 145 / 152 | 132 / 139 |
| serious Total, serious adverse events | 28 / 765 | 40 / 789 | 27 / 284 | 9 / 117 | 7 / 152 | 2 / 139 |
Outcome results
Primary
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
Immunogenicity was assessed in terms of the percentage of subjects as measured by serum bactericidal antibody titers ≥1:5 the lower limit of the two-sided 95% confidence interval (CI) was ≥75%, directed against N.meningitidis serogroup B reference strains H44/76-SL , NZ98/254, 5/99, one month after the booster (fourth) dose of meningococcal B vaccine with or without the concomitant Measles, Mumps, Rubella, Varicella (MMRV) vaccine in toddlers who were previously vaccinated with three doses of Meningococcal B vaccine.
Time frame: one month after the booster (fourth) dose
Population: The analysis was done on Per Protocol (PP) population - subjects who received all doses of vaccine in parent \& present study, provided evaluable serum samples at 1 month after booster dose or 1 month after 2nd dose, blood draw at 1 month after 3rd injection at 6 months in parent \& visit 1 blood draw in present study, had no major protocol violation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 44/76-SL (Baseline) (N=211, 215) | 81 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain NZ98/254 (Baseline) (N=211, 215) | 19 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=210, 212) | 100 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 5/99 (Baseline) (N=210, 213) | 98 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=209, 212) | 100 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=211, 213) | 97 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 5/99 (Baseline) (N=210, 213) | 100 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 44/76-SL (Baseline) (N=211, 215) | 82 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=210, 212) | 100 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=209, 212) | 100 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | One month after booster (N=211, 213) | 94 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain NZ98/254 (Baseline) (N=211, 215) | 24 Percentages of subjects |
Secondary
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers
The immune response against vaccine antigen 287-953was measured by ELISA one month after the first dose and one month after the second dose of a two-dose catch-up regimens (12M13B15B and 12M12B14B) in toddlers.
Time frame: One month after the first dose and one month after the second dose.
Population: The analysis was done on the SBA PP Catch-up population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | 1 M after 2nd Vac. | 5698 IU/mL |
| 12B12M (1a) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | Baseline (N=162,66) | 20 IU/mL |
| 12B12M (1a) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | 1 M after 1st Vac. (N=162,64) | 113 IU/mL |
| 12B13M (1b) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | 1 M after 2nd Vac. | 7154 IU/mL |
| 12B13M (1b) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | Baseline (N=162,66) | 22 IU/mL |
| 12B13M (1b) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 After Two-dose Catch-up in Toddlers | 1 M after 1st Vac. (N=162,64) | 120 IU/mL |
Secondary
ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response against vaccine antigen 287-953 was measured by ELISA, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
Time frame: One month after the fourth (booster) dose.
Population: The analysis was done on the SBA PP Booster population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months | Baseline (N=212,216) | 390 IU/mL |
| 12B12M (1a) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months | 1 M after Booster (N=213, 214) | 6225 IU/mL |
| 12B13M (1b) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months | Baseline (N=212,216) | 389 IU/mL |
| 12B13M (1b) | ELISA Geometric Mean Concentration Against Vaccine Antigen 287-953 One Month After the Fourth (Booster) Dose Given at 12 Months | 1 M after Booster (N=213, 214) | 5608 IU/mL |
Secondary
Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory)
The immunogenicity was assessed to demonstrate the induction of immunological memory in subjects who were previously received three doses of rMenB+OMV NZ as measured by SBA GMT response in comparison to the fourth dose of rMenB+OMV NZ at 12 months of age ( 12B12M(1a) group) to the response in subjects (12M12B14B 0 who received a single dose of rMenB+OMV NZ vaccine.
Time frame: one month after booster (fourth) dose vaccination and pre-fourth dose vaccination
Population: This analysis was done on the PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 44/76-SL (Baseline) (N=211, 71) | 11 Titers |
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1 M after Booster or 1st rMenB (N=210, 71) | 140 Titers |
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 5/99 (Baseline) (N=210, 71) | 83 Titers |
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1 M after Booster or 1sr rMenB (N=209, 72) | 1538 Titers |
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | NZ98/254 (Baseline) (N=211, 71) | 2.05 Titers |
| 12B12M (1a) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1M after Booster or 1st rMenB (N=211, 72) | 39 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | NZ98/254 (Baseline) (N=211, 71) | 1.03 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 44/76-SL (Baseline) (N=211, 71) | 1.18 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1 M after Booster or 1sr rMenB (N=209, 72) | 58 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1 M after Booster or 1st rMenB (N=210, 71) | 15 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 1M after Booster or 1st rMenB (N=211, 72) | 4.18 Titers |
| 12B13M (1b) | Geometric Mean Titers After Receiving the Booster Dose and Single Dose of rMen+OMV NZ Vaccination (Induction of Immunological Memory) | 5/99 (Baseline) (N=210, 71) | 1 Titers |
Secondary
Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence)
The immunogenicity was assessed as the persistence of bactericidal antibodies at 12 months of age (pre-dose 4) who previously received three doses of rMenB+OMV NZ in the parent study as measured by hSBA GMTs directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
Time frame: one month after third vaccination and pre dose fourth (booster) vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 44/76-SL (Baseline) N=134, 131, 265,49 | 1.15 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1 M after 3rd vac.in parent study N=139,133,272,51 | 91 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Boodster vac.in present study N=139,133,272,51 | 11 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 5/99 (Baseline) N=132,129,261,49 | 1.13 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study N=139,133,272,51 | 615 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Booster vac.in present study N=139,133,272,51 | 85 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study.N=139,132,271,52 | 12 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-booster vac in present study. N=139,132,271,52 | 2.04 Titers |
| 12B12M (1a) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain NZ98/254 (Baseline) N=135,130,265,49 | 1.05 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Boodster vac.in present study N=139,133,272,51 | 10 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 5/99 (Baseline) N=132,129,261,49 | 1.24 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study N=139,133,272,51 | 620 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Booster vac.in present study N=139,133,272,51 | 79 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain NZ98/254 (Baseline) N=135,130,265,49 | 1.12 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study.N=139,132,271,52 | 14 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-booster vac in present study. N=139,132,271,52 | 2.02 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 44/76-SL (Baseline) N=134, 131, 265,49 | 1.15 Titers |
| 12B13M (1b) | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1 M after 3rd vac.in parent study N=139,133,272,51 | 83 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 44/76-SL (Baseline) N=134, 131, 265,49 | 1.15 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Booster vac.in present study N=139,133,272,51 | 82 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study N=139,133,272,51 | 617 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study.N=139,132,271,52 | 13 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain NZ98/254 (Baseline) N=135,130,265,49 | 1.09 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1 M after 3rd vac.in parent study N=139,133,272,51 | 87 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-booster vac in present study. N=139,132,271,52 | 2.03 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Boodster vac.in present study N=139,133,272,51 | 10 Titers |
| Men246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 5/99 (Baseline) N=132,129,261,49 | 1.18 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 5/99 (Baseline) N=132,129,261,49 | 1.11 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain 44/76-SL (Baseline) N=134, 131, 265,49 | 1.14 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Booster vac.in present study N=139,133,272,51 | 1.03 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-booster vac in present study. N=139,132,271,52 | 1 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Pre-Boodster vac.in present study N=139,133,272,51 | 1.08 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study N=139,133,272,51 | 1 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1M after 3rd vac. in parent study.N=139,132,271,52 | 1.07 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | 1 M after 3rd vac.in parent study N=139,133,272,51 | 1.19 Titers |
| Routine246 | Geometric Mean Titers at 12 Months of Age (Predose 4) After Previously Receiving the Three Doses of rMenB+OMV NZ (Persistence) | Strain NZ98/254 (Baseline) N=135,130,265,49 | 1 Titers |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered at 12 months. For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M and Groups 12B13M (1b) and 12B13M (3b) are combined as Group 12B13M.
Time frame: From day 1 to day 7 after each rMenB+OMV NZ vaccination.
Population: Analysis performed on the Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Irritability | 89 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Swelling | 4 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Unusual Crying | 48 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Sleepiness | 64 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash | 8 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Doc. | 2 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Fever | 6 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Fever | 2 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Antipyretic Med. Used | 79 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 87 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Doc. | 6 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any local | 113 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Tenderness | 97 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Induration | 61 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Erythema | 78 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Med. Att. Fever | 3 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Swelling | 44 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any systemic | 133 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Sal.to Doc. | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Change Eat. Habits | 61 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Vomiting | 9 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Par.to Doc. | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Diarrhea | 29 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Erythema | 81 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 74 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Par.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Induration | 61 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Unusual Crying | 48 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Antipyretic Med. Used | 69 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Vomiting | 10 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Change Eat. Habits | 44 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Sal.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Fever | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Tenderness | 80 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Swelling | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Fever | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash | 7 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any systemic | 117 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Irritability | 75 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Diarrhea | 23 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Sleepiness | 60 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any local | 104 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Swelling | 39 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Med. Att. Fever | 4 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Fever | 31 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Tenderness | 546 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Erythema | 504 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Swelling | 284 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any systemic | 695 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Change Eat. Habits | 312 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Fever | 18 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any local | 639 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Induration | 388 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Sleepiness | 362 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Vomiting | 54 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Diarrhea | 188 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Irritability | 560 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Unusual Crying | 327 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash | 57 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Doc. | 35 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Doc. | 23 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Swelling | 12 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Par.to Doc. | 0 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Sal.to Doc. | 0 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Med. Att. Fever | 8 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 356 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Antipyretic Med. Used | 436 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Diarrhea | 160 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Antipyretic Med. Used | 406 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Swelling | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Vomiting | 36 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Sleepiness | 355 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 325 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Par.to Doc. | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any systemic | 671 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Swelling | 287 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Erythema | 539 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Gland Sal.to Doc. | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Induration | 424 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Any local | 673 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | MenB Tenderness | 563 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Med. Att. Fever | 13 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Fever | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Fever | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Oth.to Doc. | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash | 56 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Unusual Crying | 294 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Change Eat. Habits | 318 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Rash Urt.to Doc. | 0 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following rMenB+OMV NZ Vaccination at 12 Months of Age | Irritability | 540 Subjects |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after rMenB+OMV NZ vaccination administered with a two-dose catch-up schedules (groups 12M13B15B and 12M12B14B).
Time frame: From day 1 to day 7 after each rMenB+MV NZ vaccination.
Population: Analysis performed on the Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Diarrhea (2nd vacc) | 41 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash (2nd vacc) | 10 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Irritability (1st vacc) | 168 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Swelling (1st vacc) | 81 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Irritability (2nd vacc) | 153 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any local (2nd vacc) | 212 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Unusual Crying (1st vacc) | 80 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Swelling (2nd vacc) | 83 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Unusual Crying (2nd vacc) | 74 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Tenderness (1st vacc) | 158 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash (1st vacc) | 13 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any systemic (1st vacc) | 216 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Fever (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Tenderness (2nd vacc) | 181 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Fever (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Change Eat. Habits (1st vacc) | 96 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Doc. (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Fever (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Doc. (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any systemic (2nd vacc) | 224 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Doc. (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Erythema (1st vacc) | 173 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Doc. (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Change Eat. Habits (2nd vacc) | 83 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Swelling (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Fever (≥ 38C) (1st vacc) | 103 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Swelling (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Sleepiness (1st vacc) | 110 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Par.to Doc. (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Erythema (2nd vacc) | 159 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Par.to Doc. (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Sleepiness (2nd vacc) | 106 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Sal.to Doc. (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Fever (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Sal.to Doc. (2nd vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Vomiting (1st vacc) | 14 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Med. Att. Fever (1st vacc) | 0 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Induration (1st vacc) | 111 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Med. Att. Fever (2nd vacc) | 2 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Vomiting (2nd vacc) | 8 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Fever (≥ 38C) (2nd vacc) | 97 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any local (1st vacc) | 211 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Antipyr. Med. Used (1st vacc) | 119 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Diarrhea (1st vacc) | 41 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Antipyretic Med. Used (2nd vacc) | 107 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Induration (2nd vacc) | 115 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Antipyretic Med. Used (2nd vacc) | 58 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash (2nd vacc) | 4 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Fever (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Fever (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Fever (≥ 38C) (1st vacc) | 54 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any local (1st vacc) | 92 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Tenderness (1st vacc) | 67 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Tenderness (2nd vacc) | 78 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Erythema (1st vacc) | 79 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Erythema (2nd vacc) | 70 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Induration (1st vacc) | 57 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Induration (2nd vacc) | 53 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Swelling (1st vacc) | 36 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | MenB Swelling (2nd vacc) | 33 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any systemic (1st vacc) | 104 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Change Eat. Habits (1st vacc) | 44 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any systemic (2nd vacc) | 99 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Change Eat. Habits (2nd vacc) | 43 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Sleepiness (1st vacc) | 55 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Sleepiness (2nd vacc) | 48 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Vomiting (1st vacc) | 2 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Vomiting (2nd vacc) | 3 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Diarrhea (1st vacc) | 34 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Diarrhea (2nd vacc) | 25 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Irritability (1st vacc) | 82 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Irritability (2nd vacc) | 73 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Unusual Crying (1st vacc) | 41 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Unusual Crying (2nd vacc) | 42 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash (1st vacc) | 9 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Fever (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Fever (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Doc. (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Oth.to Doc. (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Doc. (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Rash Urt.to Doc. (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Swelling (1st vacc) | 1 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Swelling (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Par.to Doc. (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Par.to Doc. (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Sal.to Doc. (1st vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Gland Sal.to Doc. (2nd vacc) | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Med. Att. Fever (1st vacc) | 1 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Med. Att. Fever (2nd vacc) | 2 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Fever (≥ 38C) (2nd vacc) | 50 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Antipyr. Med. Used (1st vacc) | 67 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local and Systemic Reactions During the 7 Days Following Two-dose Catch-up Schedules of rMenB+OMV NZ Vaccination | Any local (2nd vacc) | 90 Subjects |
Secondary
Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Time frame: From day 1 to day 7 after MMRV vaccination.
Population: Analysis performed on the Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Erythema | 120 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Tenderness | 56 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Induration | 53 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Swelling | 31 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Erythema | 52 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Induration | 18 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Tenderness | 39 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Swelling | 11 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Tenderness | 68 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Erythema | 60 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Swelling | 28 Subjects |
| Men246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Induration | 30 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Swelling | 122 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Induration | 161 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Erythema | 345 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Local Reactions During the 7 Days Following MMRV Vaccination at 12 Months of Age | MMRV Tenderness | 353 Subjects |
Secondary
Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age
Safety was assessed as the number of subjects who reported solicited systemic reactions from day 8 through day 28 after the MMRV vaccination concomitantly with rMenB+OMV NZ at 12 months of age (groups 12B12M, 12M12B14B, 12B12M\_C) or after MMRV vaccination alone without rMenB+OMV NZ at 12 months (Group 12M13B15B). For the safety analysis purpose, Groups 12B12M (1a) and 12B12M (3a) are combined as Group 12B12M.
Time frame: From day 8 to day 28 after MMRV vaccination.
Population: Analysis performed on the Safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Med. Att. Fever | 19 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Fever | 4 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Sal.to Doc. | 1 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Doc. | 2 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Doc. | 3 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Antipyretic Med. Used | 119 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 131 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Fever | 6 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash | 50 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Par.to Doc. | 1 Subjects |
| 12B12M (1a) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Swelling | 8 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Doc. | 1 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash | 23 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Par.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Antipyretic Med. Used | 55 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Sal.to Doc. | 0 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Fever | 3 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Swelling | 3 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Fever | 1 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 46 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Doc. | 1 Subjects |
| 12B13M (1b) | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Med. Att. Fever | 6 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 62 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash | 17 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Fever | 4 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Fever | 2 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Doc. | 3 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Doc. | 1 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Swelling | 5 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Par.to Doc. | 1 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Sal.to Doc. | 1 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Med. Att. Fever | 15 Subjects |
| Men246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Antipyretic Med. Used | 48 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Swelling | 20 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Doc. | 8 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Antipyretic Med. Used | 324 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Med. Att. Fever | 54 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Doc. | 10 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Oth.to Fever | 19 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Fever ( ≥ 38C ) | 338 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash | 147 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Par.to Doc. | 3 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Rash Urt.to Fever | 14 Subjects |
| Routine246 | Number of Subjects Reporting Solicited Systemic Reactions During 8-28 Days Following MMRV Vaccination at 12 Months of Age | Gland Sal.to Doc. | 5 Subjects |
Secondary
Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination
Immunogenicity was assessed to demonstrate non-inferiority in terms of percentages of subjects as measured by antibody responses against MMRV vaccine when given concomitantly with the booster (fourth) dose of rMenB+OMV NZ vaccine at 12 months of age when compared to MMRV vaccine when given alone. The specified cut-off levels for the vaccine antigens : for measles antigen is ≥255mIU/mL, Mumps antigen is ≥10 Enzyme Linked Immunosorbent Assay(ELISA) Antibody(Ab) units, Rubella antigen is ≥10 IU/mL, Varicella antigen is ≥1.25 glycoprotein (gp) ELISA units/ml (seroconversion) and varicella antigen is ≥5 gp ELISA units/ml (seroprotection.
Time frame: one month after booster (fourth) dose
Population: This analysis was done on Per Protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Mumps(strain RIT4385)≥10 U/mL(Baseline)(N=157,152) | 0 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=156, 151) | 96 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Varicella (Oka, ≥1.25), Bas (N=147,141) | 0 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Rubella (Wistar RA 27/3) ≥10 (Bas N=163,156) | 0 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=151,146) | 98 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=162, 155) | 99 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=146,140) | 97 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | VarII 2 months after MMRV vaccine (N=146, 140) | 79 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Varicella (Oka, ≥5), Bas (N=147,141) | 0 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Measles strain Schwarz≥255mIU/mLBaselineN=152,147 | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Varicella (Oka, ≥5), Bas (N=147,141) | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Measles strain Schwarz≥255mIU/mLBaselineN=152,147 | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=151,146) | 99 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Mumps(strain RIT4385)≥10 U/mL(Baseline)(N=157,152) | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=162, 155) | 100 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Varicella (Oka, ≥1.25), Bas (N=147,141) | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | VarII 2 months after MMRV vaccine (N=146, 140) | 81 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=156, 151) | 96 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | Rubella (Wistar RA 27/3) ≥10 (Bas N=163,156) | 0 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Antibody Response After Receiving the MMRV Vaccination | 2 months after MMRV vaccine (N=146,140) | 99 Percentages of subjects |
Comparison: The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the measles antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Measles antigen was greater than -10%.95% CI: [-5, 2]
Comparison: The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B(2a), if for the mumps antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for Mumps antigen was greater than -10%.95% CI: [-5, 5]
Comparison: The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the rubella antigen(two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for rubella antigen was greater than -10%.95% CI: [-4, 1]
Comparison: The immunogenicity in 12B12M(1a) group was considered non-inferior to that in group 12M13B15B (2a), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of subjects with antibody response greater than or equal to the specified cut-off level for varicella antigen was greater than -10%.95% CI: [-6, 3]
Comparison: The immunogenicity in 12B12M (1a) group was considered non-inferior to that in group 12M13B15B (2), if for the varicella antigen (two months after the MMRV vaccine), the lower limit of the two-sided 95% CI for the difference in the percentages of the subjects with antibody response greater than or equal to the specified cut-off value for varicella antigen was greater than -10%.95% CI: [-11, 7]
Secondary
Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months
The immune response was measured as percentages of subjects with SBA ≥ 1:5 (95% CI) against strain M10713, one month after the fourth (booster) dose given at 12 months of age (groups 12B12M (1a), 12B13M (1b).
Time frame: One month after the fourth (booster) dose.
Population: The analysis was done on the SBA PP Booster population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months | Pre-Booster Vac. | 84 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months | 1 Month After Booster | 100 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months | Pre-Booster Vac. | 59 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With Bactericidal Titers ≥ 1:5 (95% CI) Against Strain M10713 One Month After the Fourth (Booster) Dose Given at 12 Months | 1 Month After Booster | 100 Percentages of Subjects |
Secondary
Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed as percentages of subjects with SBA titers ≥1:5 one month after the second dose.
Time frame: One month after the second dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain H44/76, Baseline (N=161,67) | 5 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain 5/99, Baseline (N=160, 67) | 1 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=164, 67) | 100 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=163, 67) | 100 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain NZ98/254, Baseline (N=162, 67) | 1 Percentages of Subjects |
| 12B12M (1a) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1M after 2nd Vac. (N=164, 68) | 100 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain H44/76, Baseline (N=161,67) | 3 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=163, 67) | 100 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain NZ98/254, Baseline (N=162, 67) | 0 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain 5/99, Baseline (N=160, 67) | 1 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=164, 67) | 100 Percentages of Subjects |
| 12B13M (1b) | Percentages of Subjects With SBA Titers ≥1:5 After a Two-dose Catch-up Schedule or Two-dose Schedule | 1M after 2nd Vac. (N=164, 68) | 96 Percentages of Subjects |
Secondary
Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence)
Immunogenicity was assessed to evaluate the persistence in terms of percentages of subjects with hSBA titers ≥ 1:5, previously received three doses of rMenB+OMV NZ directed against N meningitidis serogroup B reference strains H44/76, NZ98/254 and 5/99.
Time frame: One month post vaccination and pe-booster (fourth) dose vaccination
Population: The analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 5/99 Baseline in parent study N=132,129,261,49 | 4 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-booster vac. in present study.N=139,133,272,51 | 81 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac in parent study.N=139,133,272,51 | 100 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | NZ98/254 Baseline in parent study N=135,130,265,49 | 1 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1M after 3rd vac in parent study N=139,133,272,51 | 100 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Booster vac in present study N=139,132,271,52 | 21 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac. in parent studyN=139,132,271,52 | 81 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Boostervac.in present study N=139,133,272,51 | 98 Percentages of subjects |
| 12B12M (1a) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 44/76-SL Baseline in present studyN=134,131,265,49 | 3 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | NZ98/254 Baseline in parent study N=135,130,265,49 | 4 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac. in parent studyN=139,132,271,52 | 85 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Booster vac in present study N=139,132,271,52 | 20 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 5/99 Baseline in parent study N=132,129,261,49 | 5 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 44/76-SL Baseline in present studyN=134,131,265,49 | 3 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Boostervac.in present study N=139,133,272,51 | 100 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac in parent study.N=139,133,272,51 | 99 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-booster vac. in present study.N=139,133,272,51 | 82 Percentages of subjects |
| 12B13M (1b) | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1M after 3rd vac in parent study N=139,133,272,51 | 99 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1M after 3rd vac in parent study N=139,133,272,51 | 100 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 44/76-SL Baseline in present studyN=134,131,265,49 | 3 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | NZ98/254 Baseline in parent study N=135,130,265,49 | 2 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac in parent study.N=139,133,272,51 | 100 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-booster vac. in present study.N=139,133,272,51 | 81 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 5/99 Baseline in parent study N=132,129,261,49 | 4 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Booster vac in present study N=139,132,271,52 | 20 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac. in parent studyN=139,132,271,52 | 83 Percentages of subjects |
| Men246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Boostervac.in present study N=139,133,272,51 | 99 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Booster vac in present study N=139,132,271,52 | 0 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 44/76-SL Baseline in present studyN=134,131,265,49 | 4 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-booster vac. in present study.N=139,133,272,51 | 2 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 5/99 Baseline in parent study N=132,129,261,49 | 2 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1M after 3rd vac in parent study N=139,133,272,51 | 0 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | Pre-Boostervac.in present study N=139,133,272,51 | 0 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | NZ98/254 Baseline in parent study N=135,130,265,49 | 0 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac in parent study.N=139,133,272,51 | 0 Percentages of subjects |
| Routine246 | Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Previously Receiving the Three Doses of rMenB+OMV NZ Vaccination (Persistence) | 1 M after 3rd vac. in parent studyN=139,132,271,52 | 2 Percentages of subjects |
Secondary
SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule
The immunogenicity of a two-dose catch-up schedule of rMenB+OMV NZ given at 13 and 15 months (12M13B15B) or 12 and 14 months (12M12B14B) to naïve toddlers was assessed by SBA GMTs one month after the second dose.
Time frame: One month after the second dose.
Population: The analysis was done on the SBA PP Catch-up population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=163, 67) | 271 Titers |
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain 5/99, Baseline (N=160, 67) | 1.06 Titers |
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain H44/76, Baseline (N=161,67) | 1.24 Titers |
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=164, 67) | 599 Titers |
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain NZ98/254, Baseline (N=162, 67) | 1.03 Titers |
| 12B12M (1a) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1M after 2nd Vac. (N=164, 68) | 43 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain NZ98/254, Baseline (N=162, 67) | 1.03 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=163, 67) | 248 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1 M after 2nd Vac. (N=164, 67) | 627 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain 5/99, Baseline (N=160, 67) | 1.03 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | 1M after 2nd Vac. (N=164, 68) | 32 Titers |
| 12B13M (1b) | SBA GMTs After a Two-dose Catch-up Schedule or Two-dose Schedule | Strain H44/76, Baseline (N=161,67) | 1.22 Titers |
Secondary
The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination
The human serum bactericidal antibody (hSBA) titer responses, one month after receiving booster dose or rMenB+OMV NZ vaccination, are reported as geometric mean titers (GMTs).
Time frame: one month after booster (fourth) vaccination.
Population: This analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 5/99 (N=210, 213) | 81 Titers |
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain NZ98/254 (N=211, 215) | 2.07 Titers |
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=209, 212) | 1503 Titers |
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=210, 212) | 139 Titers |
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=211,213) | 39 Titers |
| 12B12M (1a) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 44/76-SL (Baseline) | 11 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=211,213) | 32 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 44/76-SL (Baseline) | 10 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=210, 212) | 119 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain 5/99 (N=210, 213) | 81 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | 1 Month after booster (N=209, 212) | 1429 Titers |
| 12B13M (1b) | The Geometric Mean Titers After Receiving the Booster Dose of rMenB+OMV NZ Vaccination | Strain NZ98/254 (N=211, 215) | 2.21 Titers |