Meningococcal Disease
Conditions
Keywords
Children, Pre-school, Meningococcal disease, Prevention, Vaccination
Brief summary
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of booster doses of rMenB±OMV NZ administered to subjects at approximately 40 months of age. Antibody persistence will be subsequently measured at 18-20 months after these booster doses when the subjects are 60 months of age. Two groups of naïve subjects, aged approximately 40 and 60 months, will be recruited in the study to serve as a baseline comparator for assessing antibody persistence at these ages. These subjects will receive a two-dose catch-up regimen with rMenB+OMV NZ. Subjects who are enrolled at 40 months of age are offered DTaP/IPV and MMR vaccinations, if they have not already received these vaccines prior to enrollment.
Interventions
BIOLOGICALMeningococcal (group B) multicomponent recombinant adsorbed vaccine.
Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB+OMV NZ) or two catch-up doses.
BIOLOGICALMeningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
Subjects received either one or two booster doses of the same vaccine they had received in the parent trial (rMenB).
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Months to 62 Months
Healthy volunteers
Yes
Inclusion criteria
* Healthy 40 to 44-months-old children, who participated and completed the study V72P6 (NCT00381615; follow-on subjects) * Healthy 40 to 44-months or 60 to 62-months-old children (naïve subjects)
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 and after vaccination with the investigational vaccines (within 14 days for licensed flu vaccines)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | 28 months after last vaccination; Baseline for Naïve | 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. |
| 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. | 28 months after last vaccination; baseline for naïve | 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). |
| 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. | Day 1-7 after booster vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 month post- booster/ dose 1 for Naïve | 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 . |
| 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. | 1 month post - booster/ -dose 1 for Naïve | 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. |
| 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. | 1 month post vaccination | 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. |
| 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. | 1 month post vaccination | 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. |
| 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. | 1 month post vaccination | 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. |
| 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. | 1 month post -vaccine dose two | 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. |
| 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. | 1 month post vaccine dose two | 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. |
| 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. | 1 month post vaccine dose 2 | 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. |
| Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | 28 months after vaccination; Baseline for Naïve | 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. |
| Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | 18-20 months after last Men B vaccine; baseline for naïve_6062 | 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. |
| 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. | 28 months after last Men B vaccination; Baseline for Naïve_4042 group | 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). |
| 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. | 28 months after last Men B vaccination; baseline for naïve_4042 group | 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. |
| 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. | 1 month post booster; 1 month post dose for naïve_4042 group | 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. |
| 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. | 1 month after each booster/ vaccine dose | 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 . |
| 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. | 1 month post vaccine dose two | 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. |
| Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 18-20 months after last Men B vaccine; baseline for naïve_6062 | 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. |
| 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. | Day 1-7 after any vaccination | 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. |
| Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 18-20 months after last Men B vaccine; baseline for naïve_6062 | 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. |
| 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. | 28 months after vaccination; baseline for naïve | 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. |
| 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. | 1 month post- booster/ dose 1 for Naïve | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were enrolled from 1 center in the United Kingdom.
Pre-assignment details
All subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| 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. | 19 |
| 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. | 14 |
| 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. | 8 |
| 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. | 43 |
| 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 | 50 |
| Total | 163 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Inappropriate enrollment | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 1 | 6 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 | 3 | 5 |
Baseline characteristics
| Characteristic | 5rMenB | 5rMenB+OMV NZ | 3rMenB | 3rMenB+OMV NZ | Naive_4042 | Naive_6062 | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 41.4 months STANDARD_DEVIATION 1.5 | 41.8 months STANDARD_DEVIATION 1.4 | 41.4 months STANDARD_DEVIATION 1.5 | 40.4 months STANDARD_DEVIATION 0.7 | 41.8 months STANDARD_DEVIATION 1.7 | 61.3 months STANDARD_DEVIATION 0.9 | 47.6 months STANDARD_DEVIATION 9.2 |
| Region of Enrollment United Kingdom | 29 Subjects | 19 Subjects | 14 Subjects | 8 Subjects | 43 Subjects | 50 Subjects | 163 Subjects |
| Sex: Female, Male Female | 17 Participants | 9 Participants | 5 Participants | 3 Participants | 23 Participants | 27 Participants | 84 Participants |
| Sex: Female, Male Male | 12 Participants | 10 Participants | 9 Participants | 5 Participants | 20 Participants | 23 Participants | 79 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 | 0 / 29 | 0 / 19 | 0 / 14 | 0 / 8 | 0 / 42 | 0 / 50 |
| other Total, other adverse events | 29 / 29 | 19 / 19 | 14 / 14 | 8 / 8 | 42 / 42 | 50 / 50 |
| serious Total, serious adverse events | 1 / 29 | 1 / 19 | 0 / 14 | 1 / 8 | 2 / 42 | 2 / 50 |
Outcome results
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.
Time frame: Day 1-7 after booster vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | Antipyretic preventive medication used | 10 participants |
| 5rMenB | 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. | Injection-site erythema | 28 participants |
| 5rMenB | 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. | Injection-site pain | 17 participants |
| 5rMenB | 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. | Medically attended fever | 0 participants |
| 5rMenB | 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. | Antipyretic treatment medication used | 1 participants |
| 5rMenB | 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. | Fever (≥38°C) | 1 participants |
| 5rMenB | 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. | Rash | 3 participants |
| 5rMenB | 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. | Headache | 1 participants |
| 5rMenB | 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. | Changes in eating habits | 5 participants |
| 5rMenB | 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. | Local | 28 participants |
| 5rMenB | 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. | Irritability | 14 participants |
| 5rMenB | 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. | Diarrhea | 3 participants |
| 5rMenB | 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. | Vomiting | 1 participants |
| 5rMenB | 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. | Arthralgia | 0 participants |
| 5rMenB | 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. | Sleepiness | 13 participants |
| 5rMenB | 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. | Other | 10 participants |
| 5rMenB | 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. | Systemic | 19 participants |
| 5rMenB | 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. | Injection-site induration | 14 participants |
| 5rMenB | 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. | Injection-site swelling | 13 participants |
| 5rMenB+OMV NZ | 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. | Changes in eating habits | 10 participants |
| 5rMenB+OMV NZ | 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. | Injection-site erythema | 19 participants |
| 5rMenB+OMV NZ | 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. | Rash | 0 participants |
| 5rMenB+OMV NZ | 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. | Antipyretic preventive medication used | 12 participants |
| 5rMenB+OMV NZ | 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. | Local | 19 participants |
| 5rMenB+OMV NZ | 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. | Injection-site pain | 14 participants |
| 5rMenB+OMV NZ | 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. | Injection-site swelling | 5 participants |
| 5rMenB+OMV NZ | 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. | Injection-site induration | 9 participants |
| 5rMenB+OMV NZ | 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. | Systemic | 13 participants |
| 5rMenB+OMV NZ | 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. | Sleepiness | 12 participants |
| 5rMenB+OMV NZ | 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. | Vomiting | 3 participants |
| 5rMenB+OMV NZ | 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. | Diarrhea | 1 participants |
| 5rMenB+OMV NZ | 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. | Irritability | 10 participants |
| 5rMenB+OMV NZ | 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. | Headache | 0 participants |
| 5rMenB+OMV NZ | 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. | Arthralgia | 6 participants |
| 5rMenB+OMV NZ | 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. | Fever (≥38°C) | 1 participants |
| 5rMenB+OMV NZ | 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. | Other | 12 participants |
| 5rMenB+OMV NZ | 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. | Antipyretic treatment medication used | 2 participants |
| 5rMenB+OMV NZ | 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. | Medically attended fever | 0 participants |
| Naive_4042 | 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. | Systemic | 11 participants |
| Naive_4042 | 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. | Changes in eating habits | 5 participants |
| Naive_4042 | 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. | Arthralgia | 4 participants |
| Naive_4042 | 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. | Sleepiness | 8 participants |
| Naive_4042 | 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. | Vomiting | 3 participants |
| Naive_4042 | 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. | Headache | 2 participants |
| Naive_4042 | 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. | Antipyretic preventive medication used | 3 participants |
| Naive_4042 | 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. | Diarrhea | 3 participants |
| Naive_4042 | 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. | Irritability | 9 participants |
| Naive_4042 | 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. | Injection-site pain | 8 participants |
| Naive_4042 | 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. | Medically attended fever | 1 participants |
| Naive_4042 | 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. | Local | 14 participants |
| Naive_4042 | 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. | Injection-site induration | 8 participants |
| Naive_4042 | 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. | Injection-site erythema | 14 participants |
| Naive_4042 | 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. | Antipyretic treatment medication used | 4 participants |
| Naive_4042 | 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. | Injection-site swelling | 9 participants |
| Naive_4042 | 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. | Other | 5 participants |
| Naive_4042 | 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. | Fever (≥38°C) | 4 participants |
| Naive_4042 | 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. | Rash | 2 participants |
| 3rMenB+OMV NZ | 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. | Fever (≥38°C) | 0 participants |
| 3rMenB+OMV NZ | 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. | Injection-site erythema | 8 participants |
| 3rMenB+OMV NZ | 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. | Changes in eating habits | 4 participants |
| 3rMenB+OMV NZ | 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. | Arthralgia | 4 participants |
| 3rMenB+OMV NZ | 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. | Injection-site pain | 8 participants |
| 3rMenB+OMV NZ | 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. | Injection-site induration | 6 participants |
| 3rMenB+OMV NZ | 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. | Sleepiness | 6 participants |
| 3rMenB+OMV NZ | 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. | Headache | 1 participants |
| 3rMenB+OMV NZ | 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. | Medically attended fever | 0 participants |
| 3rMenB+OMV NZ | 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. | Rash | 1 participants |
| 3rMenB+OMV NZ | 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. | Vomiting | 0 participants |
| 3rMenB+OMV NZ | 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. | Other | 7 participants |
| 3rMenB+OMV NZ | 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. | Local | 8 participants |
| 3rMenB+OMV NZ | 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. | Diarrhea | 1 participants |
| 3rMenB+OMV NZ | 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. | Antipyretic treatment medication used | 0 participants |
| 3rMenB+OMV NZ | 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. | Antipyretic preventive medication used | 7 participants |
| 3rMenB+OMV NZ | 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. | Injection-site swelling | 4 participants |
| 3rMenB+OMV NZ | 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. | Irritability | 8 participants |
| 3rMenB+OMV NZ | 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. | Systemic | 8 participants |
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).
Time frame: 28 months after last vaccination; baseline for naïve
Population: The analysis was done on the MITT , 40 months of age, antibody persistence population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | hSBA≥1:4 (NZ 98/254 strain) | 3 Percentages of subjects |
| 5rMenB | 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. | hSBA≥1:8 (5/99 strain; N=28, 17, 40) | 43 Percentages of subjects |
| 5rMenB | 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. | hSBA≥1:4 (M10713 strain; N=28, 15, 40) | 68 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:8 (H44/76 strain) | 14 Percentages of subjects |
| 5rMenB | 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. | hSBA≥1:8 (NZ 98/254 strain) | 0 Percentages of subjects |
| 5rMenB | 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. | hSBA≥1:8 (M10713 strain; N=28, 15, 40) | 61 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (H44/76 strain) | 45 Percentages of subjects |
| 5rMenB | 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. | hSBA≥1:4 (5/99 strain; N=28, 17, 40) | 43 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (H44/76 strain) | 35 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (5/99 strain; N=28, 17, 40) | 76 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (NZ 98/254 strain) | 41 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (NZ 98/254 strain) | 24 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (H44/76 strain) | 65 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (M10713 strain; N=28, 15, 40) | 67 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (5/99 strain; N=28, 17, 40) | 76 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (M10713 strain; N=28, 15, 40) | 40 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (NZ 98/254 strain) | 0 Percentages of subjects |
| Naive_4042 | 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. | hSBA ≥1:8 (H44/76 strain) | 30 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (5/99 strain; N=28, 17, 40) | 3 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (M10713 strain; N=28, 15, 40) | 45 Percentages of subjects |
| Naive_4042 | 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. | hSBA ≥1:4 (H44/76 strain) | 63 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (NZ 98/254 strain) | 0 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (M10713 strain; N=28, 15, 40) | 68 Percentages of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (5/99 strain; N=28, 17, 40) | 3 Percentages of subjects |
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.
Time frame: 28 months after last vaccination; Baseline for Naïve
Population: The analysis was done on the Modified- Intended to treat (MITT), 40 months of age, antibody persistence population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=28, 15, 40) | 9.15 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 1.09 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | 5/99 strain (N=28, 17, 40) | 5.11 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | H 44/76 strain | 3.24 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | 5/99 strain (N=28, 17, 40) | 28 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 2.77 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | H 44/76 strain | 5.34 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=28, 15, 40) | 5.34 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 1 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | 5/99 strain (N=28, 17, 40) | 1.11 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=28, 15, 40) | 8.75 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received 4 Doses of Men B Vaccine), at 40 Months of Age. | H 44/76 strain | 4.25 Titers |
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 .
Time frame: 1 month after each booster/ vaccine dose
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | 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. | after 1st booster/vaccine dose (N=13, N=7, N=38) | 2100 AU/mL |
| 5rMenB | 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. | after 2nd booster/vaccine dose (N=13, N=8, N=36) | 3790 AU/mL |
| 5rMenB+OMV NZ | 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. | after 1st booster/vaccine dose (N=13, N=7, N=38) | 1764 AU/mL |
| 5rMenB+OMV NZ | 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. | after 2nd booster/vaccine dose (N=13, N=8, N=36) | 3660 AU/mL |
| Naive_4042 | 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. | after 1st booster/vaccine dose (N=13, N=7, N=38) | 64 AU/mL |
| Naive_4042 | 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. | after 2nd booster/vaccine dose (N=13, N=8, N=36) | 3464 AU/mL |
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.
Time frame: 1 month post booster; 1 month post dose for naïve_4042 group
Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 5rMenB | 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. | 5592 AU/mL |
| 5rMenB+OMV NZ | 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. | 3934 AU/mL |
| Naive_4042 | 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. | 64 AU/mL |
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.
Time frame: 1 month post vaccination
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | 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. | M10713 strain (dose 1; N=13, 7, 38) | 35 Titers |
| 5rMenB | 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. | NZ 98/254 strain (dose 2; N=13, 8, 36) | 1.86 Titers |
| 5rMenB | 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. | H44/76 strain (dose 1; N=13, 7, 38) | 94 Titers |
| 5rMenB | 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. | M10713 strain (dose 2; N=12, 8, 36) | 21 Titers |
| 5rMenB | 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. | NZ 98/254 strain (dose 1; N=13, 7, 38) | 1.73 Titers |
| 5rMenB | 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. | 5/99 strain (dose 2; N=13, 8, 36) | 5240 Titers |
| 5rMenB | 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. | 5/99 strain (dose 1; N=13, 7, 38) | 2379 Titers |
| 5rMenB | 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. | H44/76 strain (dose 2; N=13, 8, 36) | 127 Titers |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (dose 2; N=13, 8, 36) | 65 Titers |
| 5rMenB+OMV NZ | 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. | 5/99 strain (dose 2; N=13, 8, 36) | 2413 Titers |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (dose 1; N=13, 7, 38) | 148 Titers |
| 5rMenB+OMV NZ | 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. | M10713 strain (dose 1; N=13, 7, 38) | 30 Titers |
| 5rMenB+OMV NZ | 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. | M10713 strain (dose 2; N=12, 8, 36) | 36 Titers |
| 5rMenB+OMV NZ | 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. | H44/76 strain (dose 1; N=13, 7, 38) | 76 Titers |
| 5rMenB+OMV NZ | 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. | 5/99 strain (dose 1; N=13, 7, 38) | 509 Titers |
| 5rMenB+OMV NZ | 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. | H44/76 strain (dose 2; N=13, 8, 36) | 145 Titers |
| Naive_4042 | 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. | H44/76 strain (dose 1; N=13, 7, 38) | 12 Titers |
| Naive_4042 | 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. | NZ 98/254 strain (dose 2; N=13, 8, 36) | 47 Titers |
| Naive_4042 | 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. | NZ 98/254 strain (dose 1; N=13, 7, 38) | 7.73 Titers |
| Naive_4042 | 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. | H44/76 strain (dose 2; N=13, 8, 36) | 88 Titers |
| Naive_4042 | 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. | 5/99 strain (dose 1; N=13, 7, 38) | 22 Titers |
| Naive_4042 | 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. | M10713 strain (dose 2; N=12, 8, 36) | 33 Titers |
| Naive_4042 | 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. | M10713 strain (dose 1; N=13, 7, 38) | 11 Titers |
| Naive_4042 | 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. | 5/99 strain (dose 2; N=13, 8, 36) | 1019 Titers |
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.
Time frame: 1 month post vaccine dose two
Population: The analysis was done on the MITT population, 2-dose catch-up regimen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | 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. | H44/76 strain | 88 Titers |
| 5rMenB | 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. | M10713 strain (N=36, 41) | 33 Titers |
| 5rMenB | 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. | NZ 98/254 strain | 47 Titers |
| 5rMenB | 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. | 5/99 strain | 1019 Titers |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain | 29 Titers |
| 5rMenB+OMV NZ | 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. | M10713 strain (N=36, 41) | 43 Titers |
| 5rMenB+OMV NZ | 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. | 5/99 strain | 865 Titers |
| 5rMenB+OMV NZ | 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. | H44/76 strain | 34 Titers |
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.
Time frame: 1 month post- booster/ dose 1 for Naïve
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | 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. | H44/76 strain | 99 Titers |
| 5rMenB | 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. | M10713 strain (N=28, 18, 38) | 38 Titers |
| 5rMenB | 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. | NZ 98/254 strain | 1.64 Titers |
| 5rMenB | 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. | 5/99 strain (N=28, 18, 38) | 778 Titers |
| 5rMenB+OMV NZ | 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. | 5/99 strain (N=28, 18, 38) | 1708 Titers |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain | 47 Titers |
| 5rMenB+OMV NZ | 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. | M10713 strain (N=28, 18, 38) | 39 Titers |
| 5rMenB+OMV NZ | 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. | H44/76 strain | 89 Titers |
| Naive_4042 | 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. | M10713 strain (N=28, 18, 38) | 11 Titers |
| Naive_4042 | 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. | H44/76 strain | 12 Titers |
| Naive_4042 | 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. | NZ 98/254 strain | 7.73 Titers |
| Naive_4042 | 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. | 5/99 strain (N=28, 18, 38) | 22 Titers |
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.
Time frame: 1 month post vaccine dose two
Population: The analysis was done on the MITT population, Booster response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 5rMenB | 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. | 3464 AU/mL |
| 5rMenB+OMV NZ | 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. | 1744 AU/mL |
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.
Time frame: Day 1-7 after any vaccination
Population: Analysis was done on the MITT - Two Dose Catch Up Schedule population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | Vomiting | 1 Number of subjects |
| 5rMenB | 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. | Injection-site pain | 41 Number of subjects |
| 5rMenB | 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. | Diarrhea | 7 Number of subjects |
| 5rMenB | 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. | Injection-site induration | 23 Number of subjects |
| 5rMenB | 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. | Irritability | 35 Number of subjects |
| 5rMenB | 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. | Other | 31 Number of subjects |
| 5rMenB | 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. | Headache | 8 Number of subjects |
| 5rMenB | 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. | Injection-site swelling | 31 Number of subjects |
| 5rMenB | 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. | Arthralgia | 16 Number of subjects |
| 5rMenB | 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. | Injection-site erythema | 42 Number of subjects |
| 5rMenB | 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. | Rash | 2 Number of subjects |
| 5rMenB | 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. | Systemic | 38 Number of subjects |
| 5rMenB | 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. | Fever (≥38°C) | 7 Number of subjects |
| 5rMenB | 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. | Antipyretic preventive medication used | 30 Number of subjects |
| 5rMenB | 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. | Changes in eating habits | 21 Number of subjects |
| 5rMenB | 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. | Antipyretic treatment medication used | 7 Number of subjects |
| 5rMenB | 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. | Local | 42 Number of subjects |
| 5rMenB | 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. | Medically attended fever | 0 Number of subjects |
| 5rMenB | 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. | Sleepiness | 25 Number of subjects |
| 5rMenB+OMV NZ | 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. | Medically attended fever | 1 Number of subjects |
| 5rMenB+OMV NZ | 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. | Injection-site erythema | 48 Number of subjects |
| 5rMenB+OMV NZ | 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. | Other | 33 Number of subjects |
| 5rMenB+OMV NZ | 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. | Local | 49 Number of subjects |
| 5rMenB+OMV NZ | 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. | Injection-site induration | 29 Number of subjects |
| 5rMenB+OMV NZ | 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. | Injection-site swelling | 27 Number of subjects |
| 5rMenB+OMV NZ | 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. | Systemic | 42 Number of subjects |
| 5rMenB+OMV NZ | 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. | Changes in eating habits | 23 Number of subjects |
| 5rMenB+OMV NZ | 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. | Sleepiness | 23 Number of subjects |
| 5rMenB+OMV NZ | 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. | Vomiting | 8 Number of subjects |
| 5rMenB+OMV NZ | 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. | Diarrhea | 7 Number of subjects |
| 5rMenB+OMV NZ | 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. | Irritability | 31 Number of subjects |
| 5rMenB+OMV NZ | 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. | Headache | 8 Number of subjects |
| 5rMenB+OMV NZ | 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. | Arthralgia | 16 Number of subjects |
| 5rMenB+OMV NZ | 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. | Rash | 4 Number of subjects |
| 5rMenB+OMV NZ | 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. | Fever (≥38°C) | 6 Number of subjects |
| 5rMenB+OMV NZ | 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. | Antipyretic preventive medication used | 33 Number of subjects |
| 5rMenB+OMV NZ | 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. | Antipyretic treatment medication used | 7 Number of subjects |
| 5rMenB+OMV NZ | 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. | Injection-site pain | 46 Number of subjects |
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.
Time frame: 28 months after vaccination; baseline for naïve
Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | hSBA≥1:4 (NZ 98/254 strain) | 7 percentage of subjects |
| 5rMenB | 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. | hSBA≥1:8 (NZ 98/254 strain) | 0 percentage of subjects |
| 5rMenB | 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. | hSBA≥1:8 (M10713 strain; N=13, 8, 40) | 15 percentage of subjects |
| 5rMenB | 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. | hSBA≥1:4 (5/99 strain) | 57 percentage of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (H44/76 strain) | 57 percentage of subjects |
| 5rMenB | 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. | hSBA≥1:8 (5/99 strain) | 43 percentage of subjects |
| 5rMenB | 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. | hSBA ≥1:8 (H44/76 strain) | 7 percentage of subjects |
| 5rMenB | 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. | hSBA≥1:4 (M10713 strain; N=13, 8, 40) | 54 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (H44/76 strain) | 38 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (NZ 98/254 strain) | 0 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (M10713 strain; N=13, 8, 40) | 25 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (5/99 strain) | 0 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (NZ 98/254 strain) | 0 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (5/99 strain) | 0 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (H44/76 strain) | 13 percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (M10713 strain; N=13, 8, 40) | 13 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (5/99 strain) | 3 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (5/99 strain) | 3 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (M10713 strain; N=13, 8, 40) | 45 percentage of subjects |
| Naive_4042 | 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. | hSBA ≥1:8 (H44/76 strain) | 30 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (M10713 strain; N=13, 8, 40) | 68 percentage of subjects |
| Naive_4042 | 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. | hSBA ≥1:4 (H44/76 strain) | 63 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (NZ 98/254 strain) | 0 percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (NZ 98/254 strain) | 0 percentage of subjects |
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.
Time frame: 1 month post - booster/ -dose 1 for Naïve
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | NZ 98/254 strain | 11 Percentage of subjects |
| 5rMenB | 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. | M10713 strain (N=27, 15, 37) | 41 Percentage of subjects |
| 5rMenB | 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. | 5/99 strain (N=27, 16, 37) | 100 Percentage of subjects |
| 5rMenB | 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. | H44/76 strain | 89 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain | 94 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (N=27, 16, 37) | 94 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (N=27, 15, 37) | 67 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain | 82 Percentage of subjects |
| Naive_4042 | 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. | M10713 strain (N=27, 15, 37) | 14 Percentage of subjects |
| Naive_4042 | 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. | H44/76 strain | 41 Percentage of subjects |
| Naive_4042 | 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. | 5/99 strain (N=27, 16, 37) | 68 Percentage of subjects |
| Naive_4042 | 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. | NZ 98/254 strain | 57 Percentage of subjects |
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 .
Time frame: 1 month post- booster/ dose 1 for Naïve
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | hSBA≥1:8 (5/99 strain; N=28, 18, 38) | 100 Percentage of subjects |
| 5rMenB | 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. | hSBA≥1:8 (M10713 strain; N=28, 18, 38) | 89 Percentage of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (H44/76 strain) | 100 Percentage of subjects |
| 5rMenB | 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. | hSBA≥1:8 (NZ 98/254 strain) | 11 Percentage of subjects |
| 5rMenB | 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. | hSBA≥1:4 (M10713 strain; N=28, 18, 38) | 96 Percentage of subjects |
| 5rMenB | 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. | hSBA ≥1:8 ( H44/76 strain) | 96 Percentage of subjects |
| 5rMenB | 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. | hSBA≥1:4 (NZ 98/254 strain) | 14 Percentage of subjects |
| 5rMenB | 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. | hSBA≥1:4 (5/99 strain; N=28, 18, 38) | 100 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (H44/76 strain) | 100 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (NZ 98/254 strain) | 89 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 ( H44/76 strain) | 100 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (5/99 strain; N=28, 18, 38) | 100 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (5/99 strain; N=28, 18, 38) | 100 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:4 (M10713 strain; N=28, 18, 38) | 94 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (NZ 98/254 strain) | 89 Percentage of subjects |
| 5rMenB+OMV NZ | 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. | hSBA≥1:8 (M10713 strain; N=28, 18, 38) | 94 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (5/99 strain; N=28, 18, 38) | 76 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (NZ 98/254 strain) | 66 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:4 (M10713 strain; N=28, 18, 38) | 76 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (M10713 strain; N=28, 18, 38) | 61 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (5/99 strain; N=28, 18, 38) | 71 Percentage of subjects |
| Naive_4042 | 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. | hSBA ≥1:4 (H44/76 strain) | 89 Percentage of subjects |
| Naive_4042 | 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. | hSBA ≥1:8 ( H44/76 strain) | 63 Percentage of subjects |
| Naive_4042 | 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. | hSBA≥1:8 (NZ 98/254 strain) | 58 Percentage of subjects |
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.
Time frame: 1 month post vaccination
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | H44/76 strain (dose 1; N=13, 7, 37) | 100 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (dose 1; N=13, 7, 37) | 15 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (dose 1; N=13, 7, 37) | 100 Percentages of subjects |
| 5rMenB | 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. | M10713 strain (dose 1; N=12, 7, 37) | 58 Percentages of subjects |
| 5rMenB | 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. | H44/76 strain (dose 2; N=13, 8, 34) | 100 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (dose 2; N=13, 8, 34) | 100 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (dose 2; N=13, 8, 34) | 15 Percentages of subjects |
| 5rMenB | 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. | M10713 strain (dose 2; N=11, 8, 34) | 64 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (dose 2; N=13, 8, 34) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (dose 1; N=13, 7, 37) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (dose 2; N=13, 8, 34) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (dose 1; N=13, 7, 37) | 86 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (dose 1; N=13, 7, 37) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (dose 2; N=13, 8, 34) | 88 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (dose 1; N=12, 7, 37) | 57 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (dose 2; N=11, 8, 34) | 75 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (dose 1; N=12, 7, 37) | 14 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (dose 1; N=13, 7, 37) | 41 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (dose 2; N=13, 8, 34) | 94 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (dose 2; N=11, 8, 34) | 53 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (dose 1; N=13, 7, 37) | 68 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (dose 2; N=13, 8, 34) | 100 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (dose 1; N=13, 7, 37) | 57 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (dose 2; N=13, 8, 34) | 97 Percentages of subjects |
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.
Time frame: 1 month post vaccine dose 2
Population: The analysis was done on the MITT population, 2-dose catch-up regimen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | H44/76 strain | 97 percentage of subjects |
| 5rMenB | 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. | NZ 98/254 strain | 94 percentage of subjects |
| 5rMenB | 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. | 5/99 strain | 100 percentage of subjects |
| 5rMenB | 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. | M10713 strain | 53 percentage of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain | 100 percentage of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain | 71 percentage of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain | 21 percentage of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain | 89 percentage of subjects |
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.
Time frame: 1 month post -vaccine dose two
Population: The analysis was done on the MITT population, 2-dose catch-up regimen.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | hSBA ≥1:8 (H44/76 strain) | 100 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (5/99 strain) | 100 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:8 (5/99 strain) | 100 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (NZ 98/254 strain) | 94 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:8 (NZ 98/254 strain) | 94 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:4 (M10713 strain; N=36, 41) | 89 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:4 ( H44/76 strain) | 100 Percentages of subjects |
| 5rMenB | 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. | hSBA ≥1:8 (M10713 strain; N=36, 41) | 86 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 ( H44/76 strain) | 93 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (H44/76 strain) | 93 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (NZ 98/254 strain) | 90 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (5/99 strain) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (M10713 strain; N=36, 41) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (5/99 strain) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:8 (M10713 strain; N=36, 41) | 98 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | hSBA ≥1:4 (NZ 98/254 strain) | 100 Percentages of subjects |
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.
Time frame: 18-20 months after last Men B vaccine; baseline for naïve_6062
Population: The analysis was done on the MITT, 60 months of age, antibody persistence population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 77 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 59 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 74 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 46 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 83 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 0 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 0 Percentage of subjects |
| 5rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 25 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 31 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 88 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 69 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 31 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 44 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 88 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 88 Percentage of subjects |
| 5rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 63 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 77 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 85 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 0 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 0 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 100 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 92 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 100 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 67 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 80 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 100 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 100 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 80 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 80 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 100 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 40 Percentage of subjects |
| 3rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 60 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 48 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 81 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 100 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 61 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 71 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 93 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 21 Percentage of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 31 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 2 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (NZ 98/254 strain) | 0 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (5/99 strain; N=23, 16, 13, 5, 28, 46) | 2 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 83 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (M10713 strain; N=22, 16, 12, 5, 27, 46) | 70 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:8 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 26 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (NZ 98/254 strain) | 2 Percentage of subjects |
| Naive_6062 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies ≥1:4 and ≥1:8 in Children at 60 Months of Age. | hSBA ≥1:4 (H44/76 strain; N=24, 16, 13, 5, 28, 46) | 33 Percentage of subjects |
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.
Time frame: 1 month post vaccination
Population: The analysis was done on the MITT population, booster response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 5rMenB | 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. | M10713 strain (≥1:4 - dose 2; N=12, 8, 36) | 83 Percentages of subjects |
| 5rMenB | 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. | M10713 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB | 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. | H44/76 strain (≥1:8 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (≥1:8 - dose 2; N=13, 8, 36) | 15 Percentages of subjects |
| 5rMenB | 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. | H44/76 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB | 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. | H44/76 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (≥1:8 - dose 1; N=13, 7, 38) | 15 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (≥1:8 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB | 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. | H44/76 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (≥1:4 - dose 1; N=13, 7, 38) | 15 Percentages of subjects |
| 5rMenB | 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. | M10713 strain (≥1:8 - dose 2; N=12, 8, 36) | 75 Percentages of subjects |
| 5rMenB | 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. | M10713 strain (≥1:8 - dose 1; N=13, 7, 38) | 85 Percentages of subjects |
| 5rMenB | 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. | NZ 98/254 strain (≥1:4 - dose 2; N=13, 8, 36) | 15 Percentages of subjects |
| 5rMenB | 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. | 5/99 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (≥1:8 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (≥1:8 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (≥1:4 - dose 2; N=12, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | H44/76 strain (≥1:8 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | 5/99 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (≥1:4 - dose 1; N=13, 7, 38) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | NZ 98/254 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (≥1:4 - dose 1; N=13, 7, 38) | 86 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (≥1:8 - dose 1; N=13, 7, 38) | 86 Percentages of subjects |
| 5rMenB+OMV NZ | 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. | M10713 strain (≥1:8 - dose 2; N=12, 8, 36) | 100 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (≥1:4 - dose 1; N=13, 7, 38) | 66 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (≥1:8 - dose 1; N=13, 7, 38) | 58 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (≥1:4 - dose 2; N=13, 8, 36) | 94 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (≥1:4 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (≥1:4 - dose 1; N=13, 7, 38) | 76 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (≥1:4 - dose 1; N=13, 7, 38) | 89 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (≥1:8 - dose 1; N=13, 7, 38) | 63 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (≥1:8 - dose 2; N=12, 8, 36) | 86 Percentages of subjects |
| Naive_4042 | 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. | NZ 98/254 strain (≥1:8 - dose 2; N=13, 8, 36) | 94 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (≥1:4 - dose 2; N=12, 8, 36) | 89 Percentages of subjects |
| Naive_4042 | 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. | H44/76 strain (≥1:8 - dose 2; N=13, 8, 36) | 100 Percentages of subjects |
| Naive_4042 | 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. | 5/99 strain (≥1:8 - dose 1; N=13, 7, 38) | 71 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (≥1:4 - dose 1; N=13, 7, 38) | 76 Percentages of subjects |
| Naive_4042 | 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. | M10713 strain (≥1:8 - dose 1; N=13, 7, 38) | 61 Percentages of subjects |
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.
Time frame: 28 months after vaccination; Baseline for Naïve
Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | H44/76 strain | 3.59 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 1.23 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=13, 8, 40) | 3.26 Titers |
| 5rMenB | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | 5/99 strain | 9.57 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | H44/76 strain | 3.47 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | 5/99 strain | 1 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 1 Titers |
| 5rMenB+OMV NZ | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=13, 8, 40) | 3 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | NZ 98/254 strain | 1 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | H44/76 strain | 4.25 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | 5/99 strain | 1.11 Titers |
| Naive_4042 | Persistence of Geometric Mean Antibody Titers in Children (Who Previously Received One Dose of Men B Vaccine), at 40 Months of Age. | M10713 strain (N=13, 8, 40) | 8.75 Titers |
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.
Time frame: 28 months after last Men B vaccination; baseline for naïve_4042 group
Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 5rMenB | 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. | 32 AU/mL |
| 5rMenB+OMV NZ | 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. | 28 AU/mL |
| Naive_4042 | 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. | 23 AU/mL |
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).
Time frame: 28 months after last Men B vaccination; Baseline for Naïve_4042 group
Population: The analysis was done on the MITT, 40 months of age, antibody persistence population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 5rMenB | 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. | 82 AU/mL |
| 5rMenB+OMV NZ | 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. | 62 AU/mL |
| Naive_4042 | 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. | 23 AU/mL |
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.
Time frame: 18-20 months after last Men B vaccine; baseline for naïve_6062
Population: The analysis was done on the MITT, 60 months of age, antibody persistence population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 5rMenB | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 3.13 Titers |
| 5rMenB | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 12 Titers |
| 5rMenB | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 1.05 Titers |
| 5rMenB | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 43 Titers |
| 5rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 136 Titers |
| 5rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 4.68 Titers |
| 5rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 10 Titers |
| 5rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 4.95 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 1 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 18 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 12 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 369 Titers |
| 3rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 210 Titers |
| 3rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 13 Titers |
| 3rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 11 Titers |
| 3rMenB+OMV NZ | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 25 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 8.52 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 12 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 44 Titers |
| Naive_4042 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 2.42 Titers |
| Naive_6062 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | 5/99 strain (N=23, 16, 13, 5, 28, 46) | 1.14 Titers |
| Naive_6062 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | M10713 strain (N=22, 16, 12, 5, 27, 46) | 18 Titers |
| Naive_6062 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | NZ 98/254 strain | 1.04 Titers |
| Naive_6062 | Persisting Geometric Mean Antibody Titers Against N.Meningitidis B in Children at 60 Months of Age. | H44/76 strain (N=24, 16, 13, 5, 28, 46) | 2.98 Titers |
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.
Time frame: 18-20 months after last Men B vaccine; baseline for naïve_6062
Population: The analysis was done on the MITT, 60 months of age, antibody persistence population population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 5rMenB | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 670 AU/mL |
| 5rMenB+OMV NZ | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 320 AU/mL |
| Naive_4042 | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 280 AU/mL |
| 3rMenB+OMV NZ | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 250 AU/mL |
| Naive_4042 | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 121 AU/mL |
| Naive_6062 | Persisting Geometric Mean Concentrations Against Vaccine Antigen 287-953 in Children at 60 Months of Age. | 25 AU/mL |