Infections, Meningococcal
Conditions
Keywords
Central Nervous System Diseases, Nervous System Diseases, Meningitis
Brief summary
The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
Interventions
BIOLOGICALMeningococcal group B Vaccine, rMenB+OMV NZ
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
BIOLOGICALMeningococcal ACWY Conjugate Vaccine, MenACWY
4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
85 Days to 119 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained. 2. Available for all the visits scheduled in the study. 3. In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria
1. History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment. 2. Previous known or suspected disease caused by N. meningitidis. 3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization. 4. History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine. 5. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample: * Chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. Inhaled and topical steroids are allowed), * Immune deficiency disorder, or known HIV infection. 6. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth. 7. History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable). 8. History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw. 9. Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 10. Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period. 11. Family members or household members of site research staff. 12. Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome). 13. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | At Day 331 (one month after the fourth vaccination) | Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
| hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | At Day 331 (one month after the fourth vaccination) | hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | At Day 151 (one month after the third vaccination) | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | At Day 1 | Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | At Day 1 | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | At Day 301 (before the fourth vaccination) | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | At Day 331 (one month after the fourth vaccination) | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | At Day 1 | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
| Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | At Day 151 (one month after the third vaccination) | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
| hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | At Day 1 | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. |
| Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | At Day 331 (one month after the fourth vaccination) | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301). |
| Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | At Day 331 (one month after the fourth vaccination) | Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was \<2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2). |
| Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | At Day 331 (one month after the fourth vaccination) | Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was \<4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4). |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | At Day 1 | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. |
| Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301) | Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination |
| Number of Subjects With Unsolicited Adverse Events | From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301) | An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. |
| Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Throughout the whole study period (from Day 1 upto Day 331) | A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect. |
| Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | At Day 331 (one month after fourth vaccination) | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301). |
| hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | At Day 1 | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. |
Countries
Argentina, Mexico
Participant flow
Recruitment details
750 healthy infants, aged 3 months were recruited from 3 sites in Argentina and 4 sites in Mexico.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| rMenB+ACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | 252 |
| rMenB Group Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age. | 250 |
| MenACWY Group Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. | 248 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 25 | 20 | 13 |
| Overall Study | Other: Administrative Reason | 8 | 5 | 12 |
| Overall Study | Other: Unspecified | 1 | 4 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 16 | 15 |
Baseline characteristics
| Characteristic | rMenB+ACWY Group | rMenB Group | MenACWY Group | Total |
|---|---|---|---|---|
| Age, Continuous | 104.0 Days STANDARD_DEVIATION 10.72 | 101.4 Days STANDARD_DEVIATION 10.57 | 102.7 Days STANDARD_DEVIATION 10.9 | 102.7 Days STANDARD_DEVIATION 10.77 |
| Race/Ethnicity, Customized Other | 235 Participants | 230 Participants | 231 Participants | 696 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 20 Participants | 17 Participants | 54 Participants |
| Sex: Female, Male Female | 120 Participants | 118 Participants | 139 Participants | 377 Participants |
| Sex: Female, Male Male | 132 Participants | 132 Participants | 109 Participants | 373 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 249 | 0 / 246 |
| other Total, other adverse events | 240 / 249 | 232 / 249 | 221 / 246 |
| serious Total, serious adverse events | 6 / 249 | 13 / 249 | 11 / 246 |
Outcome results
Primary
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 409 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 452 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 721 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 410 Titers |
| rMenB Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 391 Titers |
| rMenB Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 165 Titers |
| rMenB Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 536 Titers |
| rMenB Group | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 421 Titers |
Comparison: Serogroup A-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for serogroup A at one month after the fourth vaccination.95% CI: [1.97, 3.11]ANOVA
Comparison: Serogroup C-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup C at one month after the fourth vaccination.95% CI: [0.83, 1.38]ANOVA
Comparison: Serogroup W-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup W-135 at one month after the fourth vaccination.95% CI: [1.04, 1.74]ANOVA
Comparison: Serogroup Y-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + Men ACWY versus MenACWY) was performed for the serogroup Y at one month after the fourth vaccination.95% CI: [0.82, 1.35]ANOVA
Primary
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | H44/76 | 92 Titers |
| rMenB+ACWY Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | 5/99 | 1850 Titers |
| rMenB+ACWY Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | NZ98/254 | 39 Titers |
| rMenB+ACWY Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | M10713 | 13 Titers |
| rMenB Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | M10713 | 12 Titers |
| rMenB Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | H44/76 | 104 Titers |
| rMenB Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | NZ98/254 | 38 Titers |
| rMenB Group | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | 5/99 | 1790 Titers |
Comparison: H44/76- The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain,at one month after the fourth vaccination.95% CI: [0.71, 1.1]ANOVA
Comparison: 5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination.95% CI: [0.74, 1.45]ANOVA
Comparison: NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination.95% CI: [0.82, 1.25]ANOVA
Comparison: M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination.95% CI: [0.77, 1.4]ANOVA
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Time frame: At Day 151 (one month after the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 116 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 891 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 32 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 9.09 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 10 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 129 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 33 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 935 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination( Day 301).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 7.68 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 131 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 3.21 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 2.48 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 2.40 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 8.31 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 2.93 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 109 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination( Day 331).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 122 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 1404 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 37 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 18 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 17 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 126 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 36 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 1262 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (day 1).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 1.03 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 1.09 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 1.06 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 1.88 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | M10713 | 1.59 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | H44/76 | 1.02 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | NZ98/254 | 1.07 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | 5/99 | 1.07 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
Time frame: At Day 151 (one month after the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 303 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 388 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 347 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 226 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 283 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 136 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 298 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 416 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 2.05 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 2.16 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 2.33 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 2.06 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 2.16 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 2.08 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 2.31 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 2.09 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination(Day 301)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 20 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 31 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 48 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 38 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 43 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 15 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 47 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 43 Titers |
Secondary
hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.
hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 329 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 331 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 576 Titers |
| rMenB+ACWY Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 377 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup Y | 363 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup A | 132 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup W | 428 Titers |
| rMenB Group | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | Serogroup C | 311 Titers |
Secondary
Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)
A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.
Time frame: Throughout the whole study period (from Day 1 upto Day 331)
Population: Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent \& demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rMenB+ACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any Medically Attended AEs | 177 Participants |
| rMenB+ACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any SAEs | 6 Participants |
| rMenB+ACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any AEs leading to premature withdrawal | 0 Participants |
| rMenB Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any Medically Attended AEs | 188 Participants |
| rMenB Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any SAEs | 13 Participants |
| rMenB Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any AEs leading to premature withdrawal | 2 Participants |
| MenACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any SAEs | 11 Participants |
| MenACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any AEs leading to premature withdrawal | 1 Participants |
| MenACWY Group | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | Any Medically Attended AEs | 183 Participants |
Secondary
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Population: Analysis was performed on the Solicited Safety Set. The solicited safety set included all subjects who provide informed consent \& provide demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post vaccination solicited adverse events data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 2) | 78 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 4) | 84 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 3) | 83 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 2) | 142 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 1) | 162 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 3) | 24 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 2) | 46 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 4) | 81 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 3) | 42 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 2) | 37 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 4) | 29 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 3) | 139 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 2) | 99 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 1) | 53 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 3) | 73 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 2) | 104 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 217 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 3) | 92 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 2) | 16 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 4) | 59 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 3) | 86 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 2) | 51 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 1) | 46 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 2) | 74 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 2) | 10 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 4) | 71 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 2) | 48 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 4) | 126 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 1) | 111 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 4) | 15 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 4) | 75 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 1) | 124 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 1) | 101 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 4) | 84 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 1) | 19 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any local | 220 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 4) | 73 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 1) | 69 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 4) | 50 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 3) | 57 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 1) | 14 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 1) | 111 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 3) | 37 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 1) | 49 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any | 235 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 3) | 7 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 1) | 82 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 4) | 11 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 3) | 39 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 2) | 97 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 1) | 82 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 3) | 10 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 2) | 99 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 4) | 53 Participants |
| rMenB+ACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 3) | 90 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 1) | 159 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any | 226 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any local | 214 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 217 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 1) | 102 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 1) | 102 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 1) | 86 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 1) | 47 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 1) | 41 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 1) | 121 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 1) | 132 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 1) | 28 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 1) | 78 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 1) | 28 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 1) | 54 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 1) | 98 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 2) | 102 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 2) | 110 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 2) | 83 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 2) | 138 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 2) | 44 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 2) | 36 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 2) | 95 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 2) | 108 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 2) | 21 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 2) | 55 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 2) | 21 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 2) | 54 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 2) | 91 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 3) | 96 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 3) | 103 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 3) | 82 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 3) | 128 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 3) | 45 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 3) | 40 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 3) | 84 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 3) | 92 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 3) | 11 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 3) | 46 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 3) | 27 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 3) | 38 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 3) | 69 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 4) | 88 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 4) | 93 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 4) | 74 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 4) | 129 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 4) | 45 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 4) | 28 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 4) | 74 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 4) | 89 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 4) | 13 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 4) | 37 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 4) | 14 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 4) | 46 Participants |
| rMenB Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 4) | 67 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any | 194 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 3) | 60 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 2) | 47 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 4) | 57 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 3) | 11 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 1) | 25 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 1) | 22 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 3) | 39 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 1) | 10 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 4) | 11 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 3) | 14 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 1) | 23 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 4) | 56 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 3) | 25 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 1) | 54 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 1) | 22 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 3) | 31 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 1) | 18 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any local | 157 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 4) | 37 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 1) | 85 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 4) | 6 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 4) | 29 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 1) | 87 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 1) | 44 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 4) | 21 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 1) | 42 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Vomiting (vaccination 2) | 17 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 4) | 31 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 2) | 15 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 2) | 45 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 4) | 64 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Treatment of Pain/Fever (vaccination 2) | 29 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Rash (vaccination 2) | 13 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 1) | 34 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Erythema (vaccination 3) | 35 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Persistent Crying (vaccination 2) | 66 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Sleepiness (vaccination 4) | 33 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 3) | 30 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 2) | 70 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 4) | 40 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 3) | 19 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 2) | 24 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 1) | 73 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 3) | 59 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 2) | 31 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Any Systemic | 178 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Change in Eating Habits (vaccination 3) | 33 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Tenderness (vaccination 2) | 66 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 4) | 23 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Diarrhea (vaccination 3) | 25 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Swelling (vaccination 2) | 24 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Fever (vaccination 4) | 19 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Irritability (vaccination 3) | 61 Participants |
| MenACWY Group | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Induration (vaccination 2) | 32 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Time frame: From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
Population: Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent \& demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| rMenB+ACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 3) | 57 Participants |
| rMenB+ACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 4) | 44 Participants |
| rMenB+ACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 1) | 63 Participants |
| rMenB+ACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 2) | 60 Participants |
| rMenB+ACWY Group | Number of Subjects With Unsolicited Adverse Events | Any | 103 Participants |
| rMenB Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 1) | 62 Participants |
| rMenB Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 3) | 63 Participants |
| rMenB Group | Number of Subjects With Unsolicited Adverse Events | Any | 116 Participants |
| rMenB Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 4) | 58 Participants |
| rMenB Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 2) | 69 Participants |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 4) | 13 Participants |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events | Any | 70 Participants |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 1) | 20 Participants |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 2) | 29 Participants |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events | Any unsolicited AEs( vaccination 3) | 23 Participants |
Secondary
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains
Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was \<2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2).
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination (Day 301).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | H44/76 | 93 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | 5/99 | 94 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | NZ98/254 | 81 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | M10713 | 58 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | M10713 | 60 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | H44/76 | 92 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | NZ98/254 | 79 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | 5/99 | 95 Percentage of subjects |
Secondary
Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y
Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was \<4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4).
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 90 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 88 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 89 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 82 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 81 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 71 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 84 Percentage of subjects |
| rMenB Group | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 77 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 151 (one month after the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 99 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 96 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 98 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination (Day 301).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 68 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 88 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 93 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 91 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 95 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 63 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 96 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 89 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 4 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 4 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 2 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 5 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 1 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 4 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 3 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 151 (one month after the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | H44/76 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | 5/99 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 96 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | M10713 | 70 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | M10713 | 68 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | H44/76 | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 97 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | 5/99 | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline(Day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | H44/76 | 0 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | 5/99 | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | M10713 | 16 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | M10713 | 11 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | H44/76 | 1 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 1 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | 5/99 | 1 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | H44/76 | 74 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | 5/99 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | NZ98/254 | 42 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | M10713 | 33 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | M10713 | 31 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | H44/76 | 75 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | NZ98/254 | 36 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | 5/99 | 97 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 331 (One month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | H44/76 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | 5/99 | 99 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | NZ98/254 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | M10713 | 87 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | M10713 | 87 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | H44/76 | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | NZ98/254 | 98 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | 5/99 | 97 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 99 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 98 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 83 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 82 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 94 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 97 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 58 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 26 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 21 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 23 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 56 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 26 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 97 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 151 (one month after the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 92 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 65 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 59 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 92 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at baseline (day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 0 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 12 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | M10713 | 8 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | H44/76 | 0 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | NZ98/254 | 1 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | 5/99 | 1 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 151 (one month before the third vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 99 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 98 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 96 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 301 (before the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination (Day 301).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 65 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 77 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 92 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 86 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 91 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 58 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 91 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 85 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 99 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 98 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 99 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 96 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 100 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y
Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.
Time frame: At Day 1
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 1 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 2 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 4 Percentage of subjects |
| rMenB+ACWY Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 0 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup Y | 2 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup A | 1 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup W | 3 Percentage of subjects |
| rMenB Group | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Serogroup C | 2 Percentage of subjects |
Secondary
Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).
Time frame: At Day 331 (one month after the fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup A | 16 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup C | 11 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup W | 13 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup Y | 9.75 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup Y | 8.97 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup A | 8.75 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup W | 9.44 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Serogroup C | 7.79 Ratio |
Secondary
Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains
Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).
Time frame: At Day 331 (one month after fourth vaccination)
Population: Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | H44/76 | 17 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | 5/99 | 9.60 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | NZ98/254 | 11 Ratio |
| rMenB+ACWY Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | M10713 | 5.99 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | M10713 | 6.75 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | H44/76 | 16 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | NZ98/254 | 12 Ratio |
| rMenB Group | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | 5/99 | 12 Ratio |