Meningococcal Disease
Conditions
Keywords
Children, Pre-school, Meningococcal disease, Prevention, Vaccination
Brief summary
The proposed study V72P9E1 is an Extension Study of V72P9. The objectives of this extension study will be to explore antibody persistence in children at approximately 40 months of age and to evaluate the safety, tolerability and immunogenicity of a booster dose 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
BIOLOGICALrMenB
BIOLOGICALrMenB+OMV NZ
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 V72P9 (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 Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 28 months after primary vaccination; Baseline for Naïve | The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children. |
| Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 28 months after primary vaccination; Baseline for Naïve | The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA). |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Day 1 to Day 7 [after booster vaccination /post dose 1 for naive] | The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 1 month post booster / 1 month post dose 1 for Naïve | The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects. Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive\_4042 group. |
| Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 20 months post booster/ Baseline for Naïve | The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine -naïve subjects of the same age and reported as GMTs. |
| Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two 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 titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported. |
| Serum Bactericidal Antibody Titers in Children Following Two 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 serum bactericidal antibody response 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 as GMTs. |
| Percentage of Subjects With a 4-fold Increase in Antibody Titers After 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 2 | The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup 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 Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 18 months post vaccine dose 2 | The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs. |
| Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 18 months post vaccine dose two | Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported. |
| Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 20 months post booster/ Baseline for Naïve | The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age. |
| Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. | 1 month post booster /1 month post dose 1 for Naïve | The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch-up dose of rMenB+ OMV NZ in children at 40 months. |
| Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 20 months post booster/ Baseline for Naïve | The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age. |
| Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months 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. |
| Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 18 months post vaccine dose 2 | Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age. |
| Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 1 month post booster / 1 month post dose 1 | The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch-up dose of rMenB+OMV NZ in children at 40 months. |
| Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 1 month post dose 2 | The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, 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. |
| Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Day 1-7 after each vaccination | The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination. |
| Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. | 28 months after primary vaccination/ Baseline for Naïve | The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with the GMCs in vaccine-naïve children. GMCs against vaccine antigen 287-953 were measured using enzyme linked immunosorbent assay (ELISA). |
| Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 1 month post booster /1 month post dose 1 for Naïve | The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs. |
| Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 1 month post-booster/ 1 month post-dose 1 for Naïve | The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects. |
Countries
United Kingdom
Participant flow
Recruitment details
Subjects were recruited from a single center.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 4rMenB Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study. | 16 |
| 4rMenB+OMV NZ Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study. | 14 |
| 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. | 41 |
| 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. | 49 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Inappropriate enrollment | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 4 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 7 | 2 |
Baseline characteristics
| Characteristic | 4rMenB | 4rMenB+OMV NZ | Naive_4042 | Naive_6062 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.8 months STANDARD_DEVIATION 1.1 | 43.1 months STANDARD_DEVIATION 0.9 | 41.7 months STANDARD_DEVIATION 1.7 | 61.3 months STANDARD_DEVIATION 0.7 | 50.0 months STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 22 Participants | 21 Participants | 62 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 19 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 16 | 14 / 14 | 41 / 41 | 48 / 48 |
| serious Total, serious adverse events | 1 / 16 | 1 / 14 | 4 / 41 | 1 / 48 |
Outcome results
Primary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age.
The safety and tolerability of a single booster dose of rMenB or rMenB+OMV NZ vaccine in 40 month old children who had previously received three primary doses of the same vaccine as infants in parent study was assessed in terms of number of subjects with solicited local and systemic reactions following vaccination and compared to tolerability in vaccine-naive children who received 1st catch-up dose of rMenB+OMV NZ at 40 months of age.
Time frame: Day 1 to Day 7 [after booster vaccination /post dose 1 for naive]
Population: Analysis was done on the Safety population- defined as all subjects who received at least one Men B vaccination and provided post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Fever (≥38°C) | 4 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Sleepiness | 6 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Local | 14 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Rash | 2 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Vomiting | 0 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site swelling | 9 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Arthralgia | 2 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Diarrhea | 2 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Medically attended fever | 0 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Headache | 2 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Irritability | 8 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic preventive medication used | 4 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site induration | 11 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic treatment medication used | 3 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Temperature (≥40°C) | 0 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Systemic | 12 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site erythema | 13 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Other | 6 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Change in eating habits | 5 participants |
| 4rMenB | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site pain | 10 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic preventive medication used | 9 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Local | 14 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site pain | 12 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site erythema | 14 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site swelling | 6 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site induration | 5 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Systemic | 11 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Change in eating habits | 5 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Sleepiness | 6 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Vomiting | 2 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Diarrhea | 1 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Irritability | 11 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Headache | 1 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Arthralgia | 3 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Rash | 1 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Fever (≥38°C) | 1 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Other | 10 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Temperature (≥40°C) | 0 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic treatment medication used | 1 participants |
| 4rMenB+OMV NZ | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Medically attended fever | 0 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site pain | 34 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Rash | 2 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Change in eating habits | 13 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Medically attended fever | 0 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Fever (≥38°C) | 6 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Systemic | 30 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic treatment medication used | 5 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Other | 21 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site induration | 17 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Local | 38 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Temperature (≥40°C) | 1 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site swelling | 10 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Irritability | 24 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Diarrhea | 2 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Injection-site erythema | 36 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Headache | 4 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Vomiting | 1 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Antipyretic preventive medication used | 19 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Arthralgia | 9 participants |
| Naive_4042 | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After a Booster Dose of rMenB or rMenB+OMV NZ Vaccine at Forty Months of Age. | Sleepiness | 20 participants |
Primary
Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination.
The percentages of subjects with persisting serum bactericidal antibodies (hSBA) titers ≥4, against N meningitidis serogroup B at 40 months of age; twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ as compared to the vaccine-naïve children are reported. The serum bactericidal antibodies directed against serogroup B meningococci, are measured by human complement Serum Bactericidal Assay (hSBA).
Time frame: 28 months after primary vaccination; Baseline for Naïve
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 14 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 93 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 0 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | M10713 strain (N = 14,14,40) | 29 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | M10713 strain (N = 14,14,40) | 79 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 36 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 14 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 100 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | M10713 strain (N = 14,14,40) | 53 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 0 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 0 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibodies Titers ≥4, Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 3 percentages of subjects |
Primary
Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination.
The geometric mean antibody titers (GMTs) against Neisseria meningitidis serogroup B in children (at 40 months of age); twenty-eight months after completion of primary vaccination with either rMenB or rMenB+OMV NZ vaccines, are compared with the GMTs in vaccine-naïve children.
Time frame: 28 months after primary vaccination; Baseline for Naïve
Population: Modified Intention-to-treat (MITT) population was defined as enrolled subjects who actually received at least one vaccine dose,and provided at least one evaluable serum sample both before and after baseline.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 1.26 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 41 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 1 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | M10713 strain ( N = 14,14,40) | 3.6 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | M10713 strain ( N = 14,14,40) | 7.11 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 2.55 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 1.74 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 29 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | M10713 strain ( N = 14,14,40) | 4.82 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 5/99 strain (N = 14,14,40) | 1 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | NZ98/254 strain (N = 15,14,39) | 1 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 40 Months of Age), Twenty-eight Months After Completing Primary Vaccination. | 44/76-SL strain (N = 14,14,39) | 1.08 Titers |
Secondary
Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age.
The GMCs against vaccine antigen 287-953, in children one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine , is compared with GMCs following one catch-up dose of rMenB+ OMV NZ in children at 40 months.
Time frame: 1 month post booster /1 month post dose 1 for Naïve
Population: Analysis was done on MITT population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. | 5187 concentrations (AU/mL) |
| 4rMenB+OMV NZ | Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. | 3662 concentrations (AU/mL) |
| Naive_4042 | Geometric Mean Antibody Concentrations in Children, After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age. | 83 concentrations (AU/mL) |
Secondary
Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months 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: Analysis was done on the MITT population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age. | 612 concentrations (AU/mL) |
| 4rMenB+OMV NZ | Geometric Mean Antibody Concentrations in Children After Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 Months or 60 Months of Age. | 2164 concentrations (AU/mL) |
Secondary
Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination.
The persisting geometric mean antibody concentrations (GMCs) against vaccine antigen 287-953 in children (at 40 months of age), twenty-eight months after completion of primary vaccination with either rMenB or rMen+OMV NZ vaccines, are compared with 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 primary vaccination/ Baseline for Naïve
Population: Analysis was done on MITT population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. | 86 concentrations (AU/mL) |
| 4rMenB+OMV NZ | Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. | 103 concentrations (AU/mL) |
| Naive_4042 | Geometric Mean Antibody Concentrations in Children (at 40 Months of Age), Twenty Eight Months After Completing Primary Vaccination. | 27 concentrations (AU/mL) |
Secondary
Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.
Persistence of GMCs against vaccine antigen 287-953 in children (60 months of age), eighteen months after two catch-up doses of rMenB+OMV NZ vaccine given at 40 months of age.
Time frame: 18 months post vaccine dose 2
Population: Analysis was done on MITT population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Geometric Mean Antibody Concentrations in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 87 concentrations (AU/mL) |
Secondary
Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine
The persisting GMCs against vaccine antigen 287-953 in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months), are compared with GMCs in vaccine-naïve children of same age.
Time frame: 20 months post booster/ Baseline for Naïve
Population: Analysis was done on MITT population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 772 concentrations (AU/mL) |
| 4rMenB+OMV NZ | Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 358 concentrations (AU/mL) |
| Naive_4042 | Geometric Mean Antibody Concentrations in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 25 concentrations (AU/mL) |
Secondary
Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age
The safety and tolerability of a two doses of rMenB+OMV NZ vaccine in children when given either at 40 & 42 months or 60 & 62 months of age is assessed in terms of number of subjects with solicited local and systemic reactions following vaccination.
Time frame: Day 1-7 after each vaccination
Population: Analysis was done on the Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Local | 39 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site pain | 38 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site erythema | 38 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site swelling | 19 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site induration | 26 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Systemic | 39 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Change in eating habits | 20 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Sleepiness | 26 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Vomiting | 4 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Diarrhea | 4 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Irritability | 29 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Headache | 8 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Arthralgia | 13 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Rash | 3 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Fever (≥38°C) | 10 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Other | 21 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Antipyretic Preventive medication used | 24 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Antipyretic Treatment medication used | 8 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Temperature(≥40°C) | 1 participants |
| 4rMenB | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Medically attended fever | 1 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Antipyretic Treatment medication used | 12 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Local | 48 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Irritability | 29 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site pain | 46 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Other | 26 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site erythema | 46 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Headache | 12 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site swelling | 32 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Medically attended fever | 0 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Injection-site induration | 28 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Arthralgia | 24 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Systemic | 48 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Antipyretic Preventive medication used | 29 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Change in eating habits | 15 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Rash | 5 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Sleepiness | 26 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Temperature(≥40°C) | 0 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Vomiting | 7 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Fever (≥38°C) | 10 participants |
| 4rMenB+OMV NZ | Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine One Month Apart, Either at 40 or 60 Months of Age | Diarrhea | 4 participants |
Secondary
Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age
The percentages of subjects with four-fold increase in GMCs over baseline against vaccine antigen 287-953, 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 dose 2
Population: Analysis was done on MITT population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 4rMenB | Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 77 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With 4-fold Increase in Geometric Mean Antibody Concentrations, After Two Catch-up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 97 percentages of subjects |
Secondary
Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age
The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup B, one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, and compared with 4-fold increase in hSBA titers following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects. Baseline was defined as either the time that the (first) booster dose was given (i.e. at 40 months of age) or the time of the first vaccination (i.e. at 40 months of age for Naive\_4042 group.
Time frame: 1 month post booster / 1 month post dose 1 for Naïve
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 11,14,37) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N = 12,14,38) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N = 13,14,37) | 23 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 11,14,38) | 18 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 11,14,38) | 36 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 11,14,37) | 93 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N = 13,14,37) | 71 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N = 12,14,38) | 100 percentages of subjects |
| Naive_4042 | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 11,14,38) | 5 percentages of subjects |
| Naive_4042 | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N = 12,14,38) | 76 percentages of subjects |
| Naive_4042 | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N = 13,14,37) | 11 percentages of subjects |
| Naive_4042 | Percentage of Subjects With a 4-fold Increase in Antibody Titers After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 11,14,37) | 54 percentages of subjects |
Secondary
Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age
The percentages of subjects with four-fold increase in hSBA titers over baseline against N meningitidis serogroup 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: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 44/76-SL strain (N = 29,34) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 5/99 strain (N = 31,34) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | NZ 98/254 strain (N = 30,35) | 73 percentages of subjects |
| 4rMenB | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | M10713 strain (N = 29,32) | 24 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | M10713 strain (N = 29,32) | 53 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 44/76-SL strain (N = 29,34) | 100 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | NZ 98/254 strain (N = 30,35) | 69 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With a 4-fold Increase in Antibody Titers After Two Catch up Doses of rMenB+OMV NZ Vaccine Given One Month Apart Either at 40 or 60 Months of Age | 5/99 strain (N = 31,34) | 100 percentages of subjects |
Secondary
Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age
The percentage of subjects with four fold increase in GMCs over baseline against vaccine antigen 287-953 one month after receiving a single booster dose of either rMenB or rMen+OMV NZ vaccine, is compared with responses following one catch-up dose of rMenB+OMV NZ in children at 40 months.
Time frame: 1 month post booster / 1 month post dose 1
Population: Analysis was done on MITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4rMenB | Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 100 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 100 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Four Fold Increase in Geometric Mean Antibody Concentrations , After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 21 percentages of subjects |
Secondary
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine
The percentage of subjects (60 months of age) with persisting hSBA titers ≥4, twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) are compared with hSBA response in vaccine-naïve subjects of the same age.
Time frame: 20 months post booster/ Baseline for Naïve
Population: This analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 67 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain 10, 12, 46) | 0 percentages of subjects |
| 4rMenB | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 50 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 45 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 67 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain 10, 12, 46) | 17 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 100 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 67 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 4 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain 10, 12, 46) | 0 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥4, Twenty Months After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 4 percentages of subjects |
Secondary
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age
The percentages of subjects with hSBA titers ≥4 against N meningitidis serogroup B one month after receiving a single booster dose of rMenB or rMenB+OMV NZ vaccine at 40 months of age, is compared with hSBA response following one catch-up dose of rMenB+OMV NZ vaccine given at 40 months in vaccine-naive subjects.
Time frame: 1 month post-booster/ 1 month post-dose 1 for Naïve
Population: Analysis was done on MITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 44/76-SL strain (N = 13, 14, 39) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 21 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | M10713 strain (N = 13, 14, 39) | 69 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | M10713 strain (N = 13, 14, 39) | 93 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 44/76-SL strain (N = 13, 14, 39) | 100 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 93 percentages of subjects |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 100 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | M10713 strain (N = 13, 14, 39) | 62 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 87 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 23 percentages of subjects |
| Naive_4042 | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 After Receiving a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine at 40 Months of Age | 44/76-SL strain (N = 13, 14, 39) | 72 percentages of subjects |
Secondary
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.
Persisting hSBA titers ≥4 in children at 60 months of age, who had received two catch-up doses of rMenB+OMV NZ vaccine at 40 & 42 months age is reported.
Time frame: 18 months post vaccine dose two
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 44/76-SL strain | 38 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 5/99 strain | 100 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | NZ98/254 strain | 0 percentages of subjects |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4, Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | M10713 strain (N = 23) | 83 percentages of subjects |
Secondary
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age
The percentage of subjects with hSBA titers ≥4 after two catch-up doses of rMenB+OMV NZ vaccine when given either at- 40 & 42 months or 60 & 62 months of age is reported.
Time frame: 1 month post -vaccine dose two
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | 44/76-SL strain (N = 30,34) | 100 percentages |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | 5/99 strain (N = 31,34) | 100 percentages |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | NZ98/254 strain (N=31, 35) | 90 percentages |
| 4rMenB | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | M10713 strain (N = 29,33) | 72 percentages |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | M10713 strain (N = 29,33) | 97 percentages |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | 44/76-SL strain (N = 30,34) | 100 percentages |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | NZ98/254 strain (N=31, 35) | 89 percentages |
| 4rMenB+OMV NZ | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥4 Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age | 5/99 strain (N = 31,34) | 100 percentages |
Secondary
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine.
The serum bactericidal antibody response in children at 60 months of age who had received two catch-up doses of rMenB+OMV NZ vaccine at- 40 & 42 months age is reported as GMTs.
Time frame: 18 months post vaccine dose 2
Population: Analysis was done on the MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 44/76-SL strain | 2.73 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | 5/99 strain | 24 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | NZ98/254 strain | 1 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months), Eighteen Months After Receiving Two Catch-up Doses of rMenB+OMV NZ Vaccine. | M10713 strain (N = 23) | 14 Titers |
Secondary
Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine
The persisting serum bactericidal antibody titers in children (at 60 months of age), twenty months after receiving a booster dose of either rMenB or rMenB+OMV NZ vaccine (at 40 months of age) is compared with the antibody titers in vaccine -naïve subjects of the same age and reported as GMTs.
Time frame: 20 months post booster/ Baseline for Naïve
Population: Analysis was done on the MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 9.37 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 334 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain (N = 10,12,46) | 1 Titers |
| 4rMenB | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 4.96 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 5.51 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 4.69 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain (N = 10,12,46) | 1.63 Titers |
| 4rMenB+OMV NZ | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 119 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | M10713 strain (N = 8,11,45) | 8.09 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 5/99 strain (N = 9,11,46) | 1.17 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | NZ98/254 strain (N = 10,12,46) | 1 Titers |
| Naive_4042 | Persistence of Serum Bactericidal Antibody Titers in Children (at 60 Months of Age), Twenty Months After Receiving a Booster Dose of rMenB or rMenB+OMV NZ Vaccine | 44/76-SL strain (N = 9,12,46) | 1.09 Titers |
Secondary
Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age
The serum bactericidal antibody response one month after a booster dose of rMenB or rMenB+OMV NZ vaccine was given to children at 40 months of age is compared with the antibody titers following one catch-up dose rMenB+OMV NZ vaccine given at 40 months to vaccine-naive subjects and reported as GMTs.
Time frame: 1 month post booster /1 month post dose 1 for Naïve
Population: Analysis was done on MITT population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4rMenB | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 13,14,39) | 100 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 1007 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 2.15 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 13,14,39) | 10 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 13,14,39) | 23 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 13,14,39) | 114 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 32 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 926 Titers |
| Naive_4042 | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | M10713 strain (N = 13,14,39) | 6.04 Titers |
| Naive_4042 | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 5/99 strain (N=14, 14, 39) | 27 Titers |
| Naive_4042 | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | NZ98/254 strain (N=14, 14, 39) | 1.91 Titers |
| Naive_4042 | Serum Bactericidal Antibody Titers in Children After a Single Booster Dose of rMenB or rMenB+OMV NZ Vaccine Given at 40 Months of Age | 44/76-SL strain (N = 13,14,39) | 8.89 Titers |
Secondary
Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age.
The serum bactericidal antibody response 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 as GMTs.
Time frame: 1 month post vaccine dose two
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 4rMenB | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | 44/76-SL strain (N = 30,34) | 74 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | 5/99 strain (N = 31,34) | 247 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | NZ98/254 strain (N = 30,35) | 16 Titers |
| 4rMenB | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | M10713 strain (N = 29,33) | 8.91 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | M10713 strain (N = 29,33) | 44 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | 44/76-SL strain (N = 30,34) | 83 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | NZ98/254 strain (N = 30,35) | 14 Titers |
| 4rMenB+OMV NZ | Serum Bactericidal Antibody Titers in Children Following Two Doses of rMenB+OMV NZ Vaccine Given One Month Apart, Either at 40 or 60 Months of Age. | 5/99 strain (N = 31,34) | 331 Titers |