Invasive Meningococcal Disease
Conditions
Keywords
Safety, Immunogenicity, Vaccine, Meningococcal, Seroresponse
Brief summary
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Interventions
BIOLOGICALMeningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.
BIOLOGICALMeningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
BIOLOGICALMeningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
BIOLOGICALMeningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.
Exclusion criteria
* History of any meningococcal vaccine administration; * Current or previous, confirmed or suspected disease caused by N. meningitidis; * Pregnant or nursing (breastfeeding) mothers; * Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study; * Any serious, chronic, or progressive disease; * Known or suspected impairment/alteration of the immune system; * Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; * History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | One month after the second vaccination (Day 91) | Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA). |
| Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. | One month after the second vaccination (Day 91) | The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Day 1 and one month after the second vaccination (Day 91) | The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. |
| Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | One month after the second vaccination (Day 91) | The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. 4-fold increase is defined as follows; for subjects with a prevaccination hSBA \< 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase. |
| The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Day 1 and one month after the second vaccination (Day 91) | The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Day 1 and one month after second vaccination (Day 91) | Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine. |
| The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Day 1 through day 7 after any vaccination | The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY. |
| The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Throughout the study ( Day 1 to Day 241) | The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY. |
| The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | One month after the second vaccination/prevaccination (Day 91/day 1) | The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. |
| The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Day 1 and one month after the second vaccination (Day 91) | The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine. |
Countries
Poland, United States
Participant flow
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| ABCWY+OMV Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart. | 120 |
| ABCWY+qOMV Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart. | 121 |
| rMenB +OMV Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart. | 122 |
| ACWY Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later. | 121 |
| Total | 484 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Inappropriate enrollment | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 15 | 14 | 8 | 10 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 | 3 | 2 |
Baseline characteristics
| Characteristic | ABCWY+OMV | ABCWY+qOMV | rMenB +OMV | ACWY | Total |
|---|---|---|---|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 4.7 | 15.1 years STANDARD_DEVIATION 4.9 | 15.3 years STANDARD_DEVIATION 4.9 | 15.0 years STANDARD_DEVIATION 5.1 | 15.0 years STANDARD_DEVIATION 4.9 |
| Sex: Female, Male Female | 61 Participants | 68 Participants | 60 Participants | 64 Participants | 253 Participants |
| Sex: Female, Male Male | 59 Participants | 53 Participants | 62 Participants | 57 Participants | 231 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 104 / 120 | 104 / 120 | 111 / 120 | 87 / 109 |
| serious Total, serious adverse events | 2 / 120 | 2 / 120 | 1 / 120 | 3 / 109 |
Outcome results
Primary
Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.
The overall desirability index (DI) used to identify the optimal formulation of the combination vaccine was based on immunogenicity and reactogenicity parameters (on a scale of 0 to 1, with 0 for an undesirable response and 1 for a highly desirable response) as follows: Between-group ratios of hSBA GMTs were calculated, adjusted for prevaccination titer and center, against serogroups A, C, W, and Y (ABCWY+OMV group or ABCWY+qOMV group vs. Placebo/ACWY group) and against the 4 serogroup B test strains (ABCWY+OMV group or ABCWY+qOMV group vs. rMenB+OMV group). Reactogenicity was measured by the percentage of doses associated with severe local and systemic solicited AEs within 3 days following vaccination. Each immunogenicity and reactogenicity endpoint was assigned its own DI based on predefined desirability functions. The overall DI was calculated using the weighted geometric mean of the DI values of each of the ten parameters to derive an overall DI for each formulation.
Time frame: One month after the second vaccination (Day 91)
Population: Analysis was done on the Per Protocol Set - desirability, ie, all subjects who :~correctly received the vaccine at Visit 1 and Visit 2, provided evaluable serum samples pre- (Visit 1) and post-vaccination (Visit 3), provided post-vaccination solicited adverse event data an had no major protocol violation as defined prior to unblinding.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABCWY+OMV | Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. | 0.306 Desirability index |
| ABCWY+qOMV | Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters. | 0.325 Desirability index |
Primary
Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
Non-inferiority of immune response of two doses of two different formulations of MenABCWY vaccine to a single dose of MenACWY vaccine as measured by the percentage of subjects with hSBA seroresponse against N.meningitidis serogroups A,C,W and Y. Seroresponse is defined as: 1. For subjects with a pre-vaccination hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; 2. For subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the prevaccination titer. Functional bactericidal antibodies directed against serogroups A,C,W,Y meningococci were measured with a serum bactericidal activity assay using human serum as the source of exogenous complement (hSBA).
Time frame: One month after the second vaccination (Day 91)
Population: Analysis was done on the per protocol population, immunogenicity, i.e subjects who received correct vaccines in both the visits; provided evaluable serum sample pre and post vaccination with assay results available for at least one serogroup and/or strain and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men W-135 | 80 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men Y | 92 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men A | 90 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men C | 95 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men W-135 | 84 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men C | 93 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men Y | 90 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men A | 92 Percentages of subjects |
| ACWY | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men Y | 75 Percentages of subjects |
| ACWY | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men A | 73 Percentages of subjects |
| ACWY | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men C | 63 Percentages of subjects |
| ACWY | Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine. | Men W-135 | 65 Percentages of subjects |
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY combination vaccine to that of one dose of MenACWY vaccine.95% CI: [5, 29]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [21, 44]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of ABCWY+OMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [0, 30]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses MenABCWY combination vaccine to that of one dose of MenACWY vaccine.95% CI: [5, 31]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup A of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [7, 30]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup C of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [18, 42]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup W-135 of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [4, 33]
Comparison: Non-inferiority of seroresponse against N.meningitidis serogroup Y of two doses of MenABCWY+qOMV combination vaccine to that of one dose of MenACWY vaccine.95% CI: [3, 29]
Secondary
Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
The percentages of subjects with at least 4-fold increase in hSBA titers against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine. 4-fold increase is defined as follows; for subjects with a prevaccination hSBA \< 1:2, a postvaccination hSBA ≥ 1:8, for subjects with a prevaccination hSBA ≥ 1:2, at least a 4-fold increase.
Time frame: One month after the second vaccination (Day 91)
Population: Analysis was done on the per-protocol population, immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 28 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ98/254 | 47 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 79 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 56 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 70 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 25 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 62 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ98/254 | 48 Percentages of subjects |
| ACWY | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 42 Percentages of subjects |
| ACWY | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ98/254 | 76 Percentages of subjects |
| ACWY | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 88 Percentages of subjects |
| ACWY | Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 75 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
The percentages of subjects with hSBA titers ≥ 1:5 and ≥ 1:8 against four different strains of N.meningitidis serogroup B, after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time frame: Day 1 and one month after the second vaccination (Day 91)
Population: Analysis was done on the per-protocol population, immunogenicity
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1; hSBA ≥1:5) | 3 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1; hSBA ≥1:5) | 9 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1; hSBA ≥1:5) | 3 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91; hSBA ≥1:5) | 64 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91; hSBA ≥1:5) | 80 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91; hSBA ≥1:5) | 71 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1; hSBA ≥1:5) | 1 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91; hSBA ≥1:5) | 80 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1; hSBA ≥1:5) | 4 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1; hSBA ≥1:5) | 14 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1; hSBA ≥1:5) | 3 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1; hSBA ≥1:5) | 5 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91; hSBA ≥1:5) | 82 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91; hSBA ≥1:5) | 93 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 and ≥ 1:8 Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1; hSBA ≥1:5) | 4 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
Percentages of subjects with hSBA titers ≥ 1:8 against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine or one dose of MenACWY vaccine.
Time frame: Day 1 and one month after second vaccination (Day 91)
Population: Analysis was done on the per protocol population, immunogenicity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 8 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 93 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 35 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 99 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 66 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 100 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 18 Percentages of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 97 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 35 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 15 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 100 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 58 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 100 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 6 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 95 Percentages of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 97 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 32 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 73 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 1 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 83 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 8 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 89 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 51 Percentages of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 82 Percentages of subjects |
Secondary
The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
The geometric mean ratio (GMR) of post vaccination versus pre vaccination GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time frame: One month after the second vaccination/prevaccination (Day 91/day 1)
Population: Analysis was done on the per-protocol population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY+OMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 7.32 Ratio |
| ABCWY+OMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 48 Ratio |
| ABCWY+OMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 | 7.44 Ratio |
| ABCWY+OMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 2.94 Ratio |
| ABCWY+qOMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 2.59 Ratio |
| ABCWY+qOMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 9.41 Ratio |
| ABCWY+qOMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 | 6.91 Ratio |
| ABCWY+qOMV | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 30 Ratio |
| ACWY | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 | 5.16 Ratio |
| ACWY | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 | 98 Ratio |
| ACWY | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 | 16 Ratio |
| ACWY | The Geometric Mean Ratio of Post vs Pre Vaccination GMTs Against N.Meningitidis Serogroup B, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 | 14 Ratio |
Secondary
The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
The hSBA GMTs against N.meningitidis serogroup B after two doses of ABCWY+OMV, ABCWY+qOMV or rMenB+OMV vaccine.
Time frame: Day 1 and one month after the second vaccination (Day 91)
Population: Analysis was done on the per-protocol population, immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1) | 1.32 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91) | 55 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91) | 9.24 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1) | 1.08 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1) | 1.2 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 91) | 8.68 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 1) | 2.55 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 91) | 7.24 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 1) | 2.45 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1) | 1.72 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91) | 48 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1) | 1.1 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 91) | 7.88 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1) | 1.15 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 91) | 6.26 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91) | 11 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 1) | 1.26 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 1) | 1.14 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 91) | 19 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M01-0240364 (Day 91) | 118 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 1) | 2.13 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M14459 (Day 91) | 17 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | NZ 98/254 (Day 1) | 1.21 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis serogroupB, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | M07-0241084 (Day 91) | 12 Titers |
Secondary
The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine.
The hSBA GMTs against N.meningitidis serogroups A,C,W-135 and Y, after two doses of either ABCWY+OMV or ABCWY+qOMV combination vaccine, or one dose of MenACWY vaccine.
Time frame: Day 1 and one month after the second vaccination (Day 91)
Population: Analysis was done on the per protocol population, immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 149 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 1.57 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 214 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 2.01 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 14 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 4.15 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 71 Titers |
| ABCWY+OMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 239 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 3.72 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 77 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 1.91 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 1.32 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 129 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 288 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 187 Titers |
| ABCWY+qOMV | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 10 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 91) | 46 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 1) | 1.33 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men A (Day 91) | 45 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 1) | 3.93 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 1) | 6.58 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men W-135 (Day 91) | 65 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men Y (Day 1) | 1.52 Titers |
| ACWY | The hSBA GMTs Against N.Meningitidis Serogroups A,C,W-135 and Y, After Vaccination With Different Formulations of MenABCWY Combination Vaccine. | Men C (Day 91) | 55 Titers |
Secondary
The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study.
The number of subjects reporting solicited local and systemic adverse events and other indicators of reactogenicity after vaccination with ABCWY+OMV, ABCWY+qOMV or rMenB+OMV or MenACWY.
Time frame: Day 1 through day 7 after any vaccination
Population: Analysis was done on the solicited safety set, ie all subjects in the all exposed set who provided postvaccination solicited AE data from day 1 (6 hours) through day 7. The all exposed set is defined as all subjects in the all enrolled population who actually received a study vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fever ( >= 38C ) | 7 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Nausea | 15 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site erythema | 57 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Loss of appetite | 17 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Prophylactic use of antipyretic | 17 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fatigue | 32 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Headache | 37 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site induration | 46 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Therapeutic use of antipyretic | 18 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Myalgia | 65 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Chills | 18 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Rash | 6 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended fever | 2 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Arthralgia | 20 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site pain | 98 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Arthralgia | 23 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Headache | 40 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Loss of appetite | 22 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Rash | 8 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site pain | 96 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site erythema | 53 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Chills | 21 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Prophylactic use of antipyretic | 14 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Nausea | 25 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Therapeutic use of antipyretic | 26 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fatigue | 47 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended fever | 0 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Myalgia | 67 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site induration | 52 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fever ( >= 38C ) | 5 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Arthralgia | 25 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site erythema | 72 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site induration | 46 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site pain | 107 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Chills | 29 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Nausea | 30 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fatigue | 52 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Myalgia | 67 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Headache | 53 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Rash | 4 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Loss of appetite | 24 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fever ( >= 38C ) | 6 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended fever | 0 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Prophylactic use of antipyretic | 16 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Therapeutic use of antipyretic | 27 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site induration | 24 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site pain | 50 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fever ( >= 38C ) | 1 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Myalgia | 38 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Fatigue | 30 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Injection site erythema | 30 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended fever | 0 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Nausea | 8 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Chills | 12 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Therapeutic use of antipyretic | 10 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Rash | 6 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Headache | 29 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Prophylactic use of antipyretic | 7 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Loss of appetite | 12 Participants |
| ACWY | The Number of Subjects Reporting Solicited Adverse Events After Receiving Any Vaccination in This Study. | Arthralgia | 7 Participants |
Secondary
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study.
The number of subjects reporting unsolicited AEs after vaccination with ABCWY+OMV, ABCWY+qOMV, rMenB+OMV or MenACWY.
Time frame: Throughout the study ( Day 1 to Day 241)
Population: Analysis was done on the unsolicited safety set, ie, all subjects in the all exposed set who provided postvaccination unsolicited AE data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Possibly/probably related SAEs | 0 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Deaths (Day 1 to Day 241) | 0 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | possibly related med.attend.AEs (day 92-241) | 0 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (from day 1 to 30) | 36 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | SAEs (Day 1 to Day 241) | 2 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (day 31 to 60 or study termination) | 22 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 31 to 60 or study term.) | 0 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least possibly related AEs (day 1 to 30) | 12 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | AEs leading to withdrawal (Day 1 to Day 241) | 0 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AE from day 1 to 91 | 51 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 1 to 91) | 13 Participants |
| ABCWY+OMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended AEs (day 92 to 241) | 26 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least possibly related AEs (day 1 to 30) | 10 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended AEs (day 92 to 241) | 24 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 31 to 60 or study term.) | 1 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | SAEs (Day 1 to Day 241) | 2 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Possibly/probably related SAEs | 0 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | possibly related med.attend.AEs (day 92-241) | 0 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (from day 1 to 30) | 36 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 1 to 91) | 10 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AE from day 1 to 91 | 55 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (day 31 to 60 or study termination) | 29 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Deaths (Day 1 to Day 241) | 0 Participants |
| ABCWY+qOMV | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | AEs leading to withdrawal (Day 1 to Day 241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | possibly related med.attend.AEs (day 92-241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (from day 1 to 30) | 45 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least possibly related AEs (day 1 to 30) | 16 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (day 31 to 60 or study termination) | 29 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 31 to 60 or study term.) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AE from day 1 to 91 | 66 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 1 to 91) | 16 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended AEs (day 92 to 241) | 30 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | SAEs (Day 1 to Day 241) | 1 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Possibly/probably related SAEs | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | AEs leading to withdrawal (Day 1 to Day 241) | 2 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Deaths (Day 1 to Day 241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 1 to 91) | 6 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AE from day 1 to 91 | 50 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (from day 1 to 30) | 31 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Possibly/probably related SAEs | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least poss.rel.AEs(day 31 to 60 or study term.) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Any AEs (day 31 to 60 or study termination) | 26 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Deaths (Day 1 to Day 241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | AEs leading to withdrawal (Day 1 to Day 241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | possibly related med.attend.AEs (day 92-241) | 0 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | Medically attended AEs (day 92 to 241) | 31 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | At least possibly related AEs (day 1 to 30) | 6 Participants |
| ACWY | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Any Vaccination in This Study. | SAEs (Day 1 to Day 241) | 3 Participants |
Post Hoc
Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99
Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B strains 44/76 and 5/99 at one month after second vaccination are calculated
Time frame: At baseline and one month after second vaccination (Day 91)
Population: Analysis was done on the per-protocol population, immunogenicity. This exploratory analysis was performed only on strains 44/76 and 5/99.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- Baseline | 6 Percentage of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- 1 month after second dose | 100 Percentage of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- Baseline | 11 Percentage of subjects |
| ABCWY+OMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- 1 month after second dose | 99 Percentage of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- 1 month after second dose | 99 Percentage of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- Baseline | 7 Percentage of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- Baseline | 15 Percentage of subjects |
| ABCWY+qOMV | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- 1 month after second dose | 99 Percentage of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- 1 month after second dose | 98 Percentage of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- 1 month after second dose | 98 Percentage of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 5/99- Baseline | 16 Percentage of subjects |
| ACWY | Percentages of Subjects With hSBA Titers ≥ 1:5 Against N.Meningitidis Serogroup B Strains 44/76 and 5/99 | 44/76- Baseline | 7 Percentage of subjects |