| Primary | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | Persistence of geometric mean titers (GMTs) against N.meningitidis B strains in children (at 40 months of age) who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children. | The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 months after last vaccination; Baseline for Naïve | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
| | | Title | Denominators | Categories |
|---|
| H 44/76 strain | | | Title | Measurements |
|---|
| - OG0003.24(2.33 to 4.52)
- OG0015.34(3.47 to 8.23)
- OG0024.25(3.22 to 5.6)
|
| | 5/99 strain (N=28, 17, 40) |
| |
| Primary | Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Persisting Human Complement Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 at 40 Months of Age. | The percentages of subjects with persisting human serum bactericidal antibodies (hSBA) titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains at 40 months of age; who had previously received four doses of either rMenB or rMen+OMV NZ vaccines in parent study are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA). | The analysis was done on the MITT , 40 months of age, antibody persistence population. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 28 months after last vaccination; baseline for naïve | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 |
|
| Primary | Number of Subjects Reporting Solicited Adverse Events After a Receiving One or Two Booster Doses of rMen B or rMenB+OMV NZ Vaccine at 40 Months of Age. | The safety and tolerability of one or two booster doses of rMen B or rMenB+OMV NZ vaccine administered at 40 months of age in children who had previously received one or four doses of the same vaccine as infants in parent study is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination. | Analysis was done on the safety population i.e all subjects who received at least one Men B vaccination and provided post-baseline safety data. | Posted | | Number | | participants | | Day 1-7 after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. |
|
| Secondary | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | Persisting GMTs against N.meningitidis B strains in children (at 40 months of age) who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study, are compared with the GMTs in vaccine-naïve children. | The analysis was done on the MITT, 40 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 28 months after vaccination; Baseline for Naïve | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Percentage of Subjects (Who Had Previously Received One Dose of Men B Vaccine) With Persisting Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8, at 40 Months of Age. | The percentages of subjects with persisting hSBA titers ≥ 1:4 and ≥1:8, against N.meningitidis B strains at 40 months of age; who had previously received one dose of either rMenB or rMen+OMV NZ vaccines in parent study are reported. | The analysis was done on the MITT, 40 months of age, antibody persistence population. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 28 months after vaccination; baseline for naïve | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. | The GMTs against N.meningitidis B strains in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects. | The analysis was done on the MITT population, booster response. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post- booster/ dose 1 for Naïve | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥1:8 After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. | The percentages of subjects (who had previously received four doses MenB vaccine in parent study) with hSBA titers ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects . | The analysis was done on the MITT population, booster response. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | 1 month post- booster/ dose 1 for Naïve | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 |
|
| Secondary | Percentage of Subjects (Who Previously Received 4 Doses of Men B Vaccine) With 4-fold Increase in Serum Bactericidal Antibody Titers After Receiving a Booster Dose of Either rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age. | The percentages of subjects (who had previously received four doses MenB vaccine in parent study) showing a 4-fold increase in hSBA titers over baseline against N.meningitidis B strains, after receiving a booster dose of either rMenB or rMen+OMV NZ vaccines at 40 months of age are compared with hSBA responses following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects. Baseline is defined as either the time that the (first) booster dose was given or the time of the first vaccination in this study. | The analysis was done on the MITT population, booster response. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | 1 month post - booster/ -dose 1 for Naïve | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. |
|
| Secondary | Geometric Mean Antibody Titers in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. | The GMTs against N.meningitidis B strains in children (who had previously received one dose MenB vaccine in parent study) after a two booster doses of either rMenB or rMenB+OMV NZ vaccine given at 40 & 42 months of age. | The analysis was done on the MITT population, booster response. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post vaccination | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
| |
| Secondary | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. | The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) with hSBA ≥ 1:4 and ≥ 1:8, against N.meningitidis B strains after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age. | The analysis was done on the MITT population, booster response. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month post vaccination | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Percentage of Subjects With 4-fold Increase in Antibody Titers After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ Vaccine at 40 & 42 Months of Age. | The percentages of subjects (who had previously received one dose of MenB vaccine in parent study) displaying 4-fold increase in antibody titers over baseline against N.meningitidis B strains, after receiving two booster doses of either rMenB or rMenB+OMV NZ vaccine at 40 & 42 months of age. | The analysis was done on the MITT population, booster response. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month post vaccination | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Percentage of Subjects With hSBA Titers ≥ 1:4 and ≥1:8 Following Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | The percentage of subjects with hSBA ≥ 1:4 and ≥ 1:8 after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported. | The analysis was done on the MITT population, 2-dose catch-up regimen. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month post -vaccine dose two | | | | ID | Title | Description |
|---|
| OG000 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. | | OG001 | Naive_6062 | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study |
| |
| Secondary | Geometric Mean Antibody Titers in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given, Either at 40 or 60 Months of Age. | The geometric mean antibody titers in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at 40 & 42 months or 60 & 62 months of age are reported. | The analysis was done on the MITT population, 2-dose catch-up regimen. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post vaccine dose two | | | | ID | Title | Description |
|---|
| OG000 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. | | OG001 | Naive_6062 | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study |
| |
| Secondary | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Receiving Two Catch up Doses of rMenB+OMV NZ Vaccine, Either at 40 or 60 Months of Age. | The percentages of subjects with four-fold increase in hSBA titers over baseline against N.meningitidis B one month after receiving a two catch-up doses of rMenB+OMV NZ vaccine either at 40 & 42 months or 60 & 62 months of age. | The analysis was done on the MITT population, 2-dose catch-up regimen. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | 1 month post vaccine dose 2 | | | | ID | Title | Description |
|---|
| OG000 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. | | OG001 | Naive_6062 | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study |
| |
| Secondary | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | The persisting GMTs against N.meningitidis B strains in children at 60 months of age who had received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present study are compared with GMTs in vaccine-naïve subjects. | The analysis was done on the MITT, 60 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 18-20 months after last Men B vaccine; baseline for naïve_6062 | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. |
|
| Secondary | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | The percentage of subjects with persisting hSBA titers ≥1:4 and ≥1:8 at 60 months of age against N.meningitidis B strains after having received one or two booster doses of either rMenB or rMenB+ OMV NZ vaccine or had received two catch-up doses of rMenB+ OMV NZ vaccine at 40 months of age in the present are reported. | The analysis was done on the MITT, 60 months of age, antibody persistence population. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | 18-20 months after last Men B vaccine; baseline for naïve_6062 | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. |
|
| Secondary | Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine in Parent Study) at 40 Months of Age. | The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 4 doses of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children. GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA). | The analysis was done on the MITT, 40 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 28 months after last Men B vaccination; Baseline for Naïve_4042 group | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 |
|
| Secondary | Persisting Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 1dose of MenB Vaccine in Parent Study) at 40 Months of Age. | The persisting GMCs against vaccine antigen 287-953 in children (at 40 months of age) who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study , are compared with the the GMCs in vaccine-naïve children. GMCs against vaccine antigen 287-953 were measure using ELISA. | The analysis was done on the MITT, 40 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 28 months after last Men B vaccination; baseline for naïve_4042 group | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children (Who Had Previously Received 4 Doses of MenB Vaccine) After Receiving One Booster Dose of Either rMenB or rMenB+OMV NZ at 40 Months of Age. | The GMCs against vaccine antigen 287-953 in children (who had previously received four doses MenB vaccine in parent study) after a single booster dose of either rMenB or rMenB+OMV NZ vaccine given at 40 months of age, are compared with the GMCs following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects. | The analysis was done on the MITT, 40 months of age, antibody persistence population. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 1 month post booster; 1 month post dose for naïve_4042 group | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | Naive_4042 |
|
| Secondary | Geometric Mean Antibody Concentrations Against Vaccine Antigen 287-953 in Children After Receiving Two Booster Doses of Either rMenB or rMenB+OMV NZ at 40 & 42 Months of Age. | The GMCs against vaccine antigen 287-953 in children (who had previously received 1 dose of either rMenB or rMen+OMV NZ vaccines in parent study) , are compared with the GMCs in children who received to catch-up doses of rMenB+OMV NZ at 40 & 42 months . | The analysis was done on the MITT population, booster response. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 1 month after each booster/ vaccine dose | | | | ID | Title | Description |
|---|
| OG000 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. | | OG001 | 3rMenB+OMV NZ | Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study. | | OG002 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. |
|
| Secondary | Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children After Two Catch up Doses of rMenB+OMV NZ Vaccine Given Either at 40 or 60 Months of Age. | The GMCs against vaccine antigen 287-953 in children after two catch-up doses of rMenB+OMV NZ vaccine when given either at - 40 & 42 months or 60 & 62 months of age are reported. | The analysis was done on the MITT population, Booster response. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 1 month post vaccine dose two | | | | ID | Title | Description |
|---|
| OG000 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. | | OG001 | Naive_6062 | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study |
| |
| Secondary | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | The persisting GMCs against vaccine antigen 287-953 in children at 60 months of age who had either received one or two booster doses of either rMenB or rMenB+OMV NZ vaccine or had received two catch-up doses of rMenB+OMV NZ vaccine at 40 months of age in the present are compared with GMCs in vaccine-naïve subjects. | The analysis was done on the MITT, 60 months of age, antibody persistence population population. | Posted | | Geometric Mean | 95% Confidence Interval | AU/mL | | 18-20 months after last Men B vaccine; baseline for naïve_6062 | | | | ID | Title | Description |
|---|
| OG000 | 5rMenB | Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study. | | OG001 | 5rMenB+OMV NZ | Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study. | | OG002 | 3rMenB | Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study. |
|
| Secondary | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine Either at 40 Months or 60 Months of Age. | The safety and tolerability of two catch-up doses of rMenB+OMV NZ vaccine when administered either at 40 & 42 months or 60 & 62 months of age in children is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination. | Analysis was done on the MITT - Two Dose Catch Up Schedule population. | Posted | | Number | | Number of subjects | | Day 1-7 after any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Naive_4042 | Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study. | | OG001 | Naive_6062 | Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study |
| |