Infections, Meningococcal, Meningococcal Disease
Conditions
Keywords
Antibody persistence, Young Adults, Healthy Adolescents, MenABCWY vaccine, Booster response, MenABCWY+OMV
Brief summary
The purpose of this study is to evaluate persistence of bactericidal antibodies for N. meningitidis serogroups A, C, W, and Y and serogroup B test strains approximately 4 years after primary vaccination in subjects who previously received a 2-dose series of MenABCWY+Outer membrane Vesicles (OMV) or a single dose of MenACWY, to evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a dose of MenABCWY+OMV in previously vaccinated subjects, and 30 days after a 2-dose series in vaccine-naive subjects of similar age, to evaluate kinetics of immune response at 3, 7, and 30 days after a booster dose of MenABCWY+OMV in previously vaccinated subjects and to explore differences in the kinetics of immune response 3, 7 and 30 days after an accelerated 2 dose series of MenABCWY+OMV separated by 30 days given to vaccine-naive subjects, and to assess immunogenicity of 2 doses of MenABCWY+OMV at Day 61 in vaccine-naive subjects and subjects who previously received one dose of MenACWY
Detailed description
Subjects will be randomised into two different blood draw schedules according to a 1:1 ratio
Interventions
BIOLOGICALMenABCWY+OMV vaccine
Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
1. Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102\_02E2 (NCT01367158), who received Tdap only in V102\_02E1 (NCT01367158) study and who received no other meningococcal vaccines; Or A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102\_02 (NCT01210885) study and have not previously received any meningococcal vaccine. 2. Individuals who / whose parent(s)/legal guardian(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures including blood draws and follow-up. 4. Males Or Females of non-childbearing potential Or Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination
Exclusion criteria
1. History of any meningococcal vaccine administration (study group C) or History of any meningococcal vaccine administration other than vaccination given in the parent V102\_02 (NCT01210885) study (study groups A and B). 2. Progressive, unstable or uncontrolled clinical conditions. 3. Hypersensitivity, including allergy, to any component of vac-cines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study. 4. Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws. 5. Abnormal function of the immune system resulting from: a.Clinical conditions. 6. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment. 7. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Received immunoglobulins or any blood products within 90 days prior to enrollment. 9. Received an investigational or non-registered medicinal product within 30 days prior to enrollment. 10. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines. 11. Study personnel as an immediate family or household member. 12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature 38°C) within 3 days prior to enrollment. 13. Who have received systemic antibiotic treatment within 3 days prior to enrollment. 14. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Day 1 (4 years persistence) | The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement. |
| Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | At Day 1 (4 years persistence) | Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8. |
| Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | At Day 1 (4 years persistence) | Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Day 1 | GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains. | At Day 31 | The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement. |
| Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Day 31 versus Day 1 | GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Day 61 versus Day 1 (baseline) | GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Within 30 min after each vaccination | Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination. |
| Number of Subjects With Any Solicited Local Symptoms | From Day 1 (6 hours) to Day 7 after each vaccination | Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. |
| Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | From Day 1 (6 hours) to Day 7 after each vaccination | Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade. |
| Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | At Days 1, 4, 8, 31, 34, 38 and 61 | Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| Number of Subjects With Medically Attended AEs Reported During the Entire Study Period. | During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) | Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period. | From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups) | The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs). | From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination. |
| Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Days 1, 4, 8 and 31 | The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement. |
| Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | At Days 1, 4, 8, 31, 34, 38 and 61 | Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8. |
| Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Days 1, 4, 8 and 31. | GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Days 4, 8 and 31 versus Day 1. | GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
| GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | At Day 61 | GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99. |
Countries
Chile, Colombia, Panama
Participant flow
Recruitment details
Subjects were recruited from 5 sites in Panama, 3 sites in Colombia and 1 site in Chile.
Pre-assignment details
Healthy adolescents and young adults, who received 2 doses of MenABCWY+OMV vaccine or 1 dose of MenACWY in the parent study V102\_02 (NCT01210885) and only Tdap vaccination in study V102\_02E1 (NCT01367158) were included in the present study along with Naive subjects of similar age.
Participants by arm
| Arm | Count |
|---|---|
| MenABCWY+OMV Group Subjects who received 2 doses of MenABCWY+OMV vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received a booster dose of MenABCWY+OMV vaccine in the current study at Day 1. | 33 |
| MenACWY Group Subjects who received MenACWY vaccine in the parent study V102\_02 (NCT01210885) and received no subsequent meningococcal vaccines, received 2 doses of MenABCWY+OMV vaccine, one month apart (Day 1 and Day 31), in the current study. | 46 |
| Naive Group Subjects similar in age to subjects in the MenABCWY+OMV and MenACWY groups, who had not previously received any meningococcal vaccine and who received 2 doses of MenABCWY+OMV vaccine, 1 month apart (Day 1 and Day 31), in the current study. | 50 |
| Total | 129 |
Baseline characteristics
| Characteristic | MenABCWY+OMV Group | MenACWY Group | Naive Group | Total |
|---|---|---|---|---|
| Age, Continuous | 18.61 Years STANDARD_DEVIATION 2.207 | 18.72 Years STANDARD_DEVIATION 1.87 | 17.96 Years STANDARD_DEVIATION 2.04 | 18.4 Years STANDARD_DEVIATION 2.04 |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants | 2 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Race Other | 20 Participants | 34 Participants | 37 Participants | 91 Participants |
| Race/Ethnicity, Customized Race White | 7 Participants | 6 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Female | 22 Participants | 27 Participants | 25 Participants | 74 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 25 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 46 | 0 / 50 |
| other Total, other adverse events | 33 / 33 | 44 / 46 | 48 / 50 |
| serious Total, serious adverse events | 0 / 33 | 0 / 46 | 0 / 50 |
Outcome results
Primary
Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMRs as measure of the immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: Day 31 versus Day 1
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 12 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 229 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 6.92 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 5.38 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 42 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 112 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 98 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 105 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 67 Ratios |
| MenABCWY+OMV Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 162 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 112 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 2.11 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 11 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 4.78 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 2.80 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 216 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 238 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 2.64 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 22 Ratios |
| MenACWY Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 2.15 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 12 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 2.48 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 5.06 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 13 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 16 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 18 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 2.72 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 46 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 2.48 Ratios |
| Naive Group | Geometric Mean hSBA Ratio (GMRs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 3.98 Ratios |
Primary
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 1
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 2.04 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 2.26 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 1.81 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 3.66 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 2.33 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 13 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 4.06 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 17 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 28 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 6.17 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 25 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 1.37 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 1.78 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 1.21 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 1.14 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 12 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 6.62 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 1.35 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 6.64 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 2.56 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 5.11 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 3.10 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 1.44 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 1.90 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 8.37 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 1.20 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 1.48 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 2.00 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 1.23 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 1.45 Titers |
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [1.03, 2.12]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [0.67, 1.28]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [0.97, 1.96]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [1.27, 3.09]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [0.63, 1.37]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [1.2, 2.84]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [0.96, 1.85]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [0.7, 1.25]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [0.91, 1.72]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [0.81, 2.53]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [0.49, 1.37]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [0.67, 2.06]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [1.33, 2.78]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [0.61, 1.17]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [1.13, 2.32]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [4.25, 12]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [0.59, 1.5]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [4.03, 11]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [0.3, 1.23]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [2.96, 10]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [1.7, 6.73]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [1.2, 5.54]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [0.66, 2.56]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [1.57, 7.11]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [0.51, 2.59]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [1.4, 6.12]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [1.49, 7.57]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [0.23, 1.18]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [2.84, 12]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [1.38, 6.92]Miettinen & Nurminen score method
Primary
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 31
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 24 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 601 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 13 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 20 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 98 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 1426 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 396 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 1676 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 1823 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 779 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 2259 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 2.83 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 19 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 5.78 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 3.05 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 1692 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 1199 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 3.57 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 149 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 5.51 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 58 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 7.70 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 7.27 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 25 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 117 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 22 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 4.02 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 85 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 3.11 Titers |
| Naive Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 5.75 Titers |
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [4.41, 16]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [0.39, 1.27]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M14459.95% CI: [3.14, 11]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [86, 452]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [0.47, 2.07]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M01-0240364.95% CI: [84, 442]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [1.96, 6.27]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [0.37, 1]Mixed Models Analysis
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, NZ98/254.95% CI: [1.23, 3.85]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [1.84, 6.92]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [0.4, 1.29]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, M10713.95% CI: [1.33, 4.89]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [8.18, 35]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [0.41, 1.53]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, H44/76.95% CI: [6.59, 28]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [34, 160]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [0.38, 1.53]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B, 5/99.95% CI: [27, 121]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [1.46, 4.83]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [3.96, 12]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup A.95% CI: [10, 32]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [0.72, 2.71]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [12, 37]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup C.95% CI: [15, 55]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [0.47, 1.38]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [12, 31]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup W.95% CI: [9.27, 26]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [0.17, 1.28]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [8.2, 48]Miettinen & Nurminen score method
Comparison: Between-group Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup Y.95% CI: [3.78, 22]Miettinen & Nurminen score method
Primary
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Immune response against N. meningitidis serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 31
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 85 Percentages of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 97 Percentages of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 82 Percentages of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 85 Percentages of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 97 Percentages of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 100 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 78 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 31 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 52 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 52 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 25 Percentages of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 37 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 29 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 52 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 82 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 58 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 40 Percentages of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 60 Percentages of Subjects |
Primary
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Antibody levels against N. meningitidis serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 1 (4 years persistence)
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 18 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 13 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 15 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 48 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 27 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 70 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 17 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 33 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 5 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 2 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 4 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 6 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 16 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 38 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 8 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 10 Percentages of subjects |
Primary
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Antibody levels against N. meningitidis serogroups A, C, W and Y in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, and in Naïve subjects as measured by the percentages of subjects with hSBA ≥ 8.
Time frame: At Day 1 (4 years persistence)
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set- all subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1 in this study) and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 27 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 69 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 75 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 38 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 59 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 41 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 78 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 43 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 19 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 45 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 53 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 2 Percentages of subjects |
Primary
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Immune response against N. meningitidis serogroups A, C, W and Y 30 days after a single dose of MenABCWY+OMV in subjects who previously vaccinated subjects, and in Naïve subjects of similar age, as measured by the percentages of subjects with hSBA ≥ 8.
Time frame: At Day 31
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 31- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 100 Percentage of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 100 Percentage of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 100 Percentage of Subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 100 Percentage of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 100 Percentage of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 100 Percentage of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 100 Percentage of Subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 100 Percentage of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 85 Percentage of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 76 Percentage of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 94 Percentage of Subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 96 Percentage of Subjects |
Primary
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and B Test Strains.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 6 and 7 and are considered final in Company's judgement.
Time frame: At Day 31
Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.
Primary
Percentages of Subjects With hSBA ≥ Lower Limit Quantitation (LLQ) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 2 and 3 and are considered final in Company's judgement.
Time frame: At Day 1 (4 years persistence)
Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.
Secondary
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMTs at Day 1, 31, 34, 38, 61 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who were not primed with any meningococcal vaccine (i.e., Naïve Group). This outcome measure reports data for only the Naïve Group as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Days 1, 31, 34, 38 and 61
Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 1.48 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 4.02 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 34 | 5.06 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 38 | 9.16 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 61 | 9.78 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 1.23 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 3.11 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 34 | 5.13 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 38 | 75 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61 | 21 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 1.45 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 5.75 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 34 | 6.93 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 38 | 7.92 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61 | 7.50 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 3.10 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 7.70 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 34 | 6.70 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 38 | 8.94 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 61 | 8.73 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 1.44 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 7.27 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 34 | 8.91 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 38 | 35 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 61 | 32 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 1.90 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 25 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 34 | 40 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 38 | 432 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 61 | 256 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 1 | 1.20 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31 | 22 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 34 | 31 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 38 | 107 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 61 | 74 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 1 | 5.11 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31 | 58 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 34 | 94 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 38 | 259 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 61 | 188 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 1 | 8.37 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31 | 117 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 34 | 180 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 38 | 188 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 61 | 168 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 1 | 2.00 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31 | 85 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 34 | 109 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 38 | 299 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 61 | 224 Titers |
Secondary
Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMTs at Day 1, 4, 8, 31 as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. This outcome measure reports data only for the MenABCWY+OMV and MenACWY Groups as per protocol. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Days 1, 4, 8 and 31.
Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 4 | 3.85 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 2.33 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 4 | 2.58 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 8 | 64 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 98 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 13 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 4 | 17 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 8 | 1768 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 1426 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 1 | 4.06 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 20 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 8 | 474 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31 | 396 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 1 | 17 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 4 | 21 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 8 | 2664 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31 | 1676 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 1 | 28 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 4 | 19 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 8 | 1285 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31 | 1823 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 1 | 6.17 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 4 | 6.53 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 8 | 722 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31 | 779 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 2.04 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 4 | 1.99 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 8 | 17 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 24 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 2.26 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4 | 2.50 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8 | 525 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 601 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 1.81 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4 | 1.90 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8 | 8.19 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 13 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 3.66 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 4 | 4.16 Titers |
| MenABCWY+OMV Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 8 | 15 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 2.56 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 5.51 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31 | 2259 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 1.21 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4 | 1.36 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 4 | 1.38 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 1 | 12 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 8 | 1.84 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8 | 1.52 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 5.78 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 4 | 9.60 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 1.78 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8 | 1.65 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 4 | 1.99 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 8 | 1133 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 8 | 1.97 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 8 | 2.03 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 19 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31 | 1692 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 1 | 6.64 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 3.05 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 4 | 9.69 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 1.37 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 8 | 61 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 3.57 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31 | 149 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 4 | 1.22 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 1 | 6.62 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 1.35 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 4 | 12 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 8 | 1.52 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 8 | 1710 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 4 | 3.73 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31 | 1199 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 2.83 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 1 | 25 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4 | 1.89 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 4 | 20 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 1.14 Titers |
| MenACWY Group | Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 8 | 1693 Titers |
Secondary
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Days 4, 8 and 31 versus Day 1.
Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 4/Day 1 | 1.35 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31/Day 1 | 6.92 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 8/Day 1 | 139 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 8/Day 1 | 8.19 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31/Day 1 | 112 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 4/Day 1 | 1.09 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 4/Day 1 | 0.95 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31/Day 1 | 229 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 8/Day 1 | 117 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 8/Day 1 | 4.02 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31/Day 1 | 98 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4/Day 1 | 1.08 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 4/Day 1 | 1.30 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31/Day 1 | 5.38 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 8/Day 1 | 164 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4/Day 1 | 1.05 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31/Day 1 | 105 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 4/Day 1 | 1.11 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 4/Day 1 | 0.90 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31/Day 1 | 12 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 8/Day 1 | 61 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 8/Day 1 | 28 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31/Day 1 | 67 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8/Day 1 | 4.53 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 4/Day 1 | 1.06 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31/Day 1 | 42 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 8/Day 1 | 156 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8/Day 1 | 210 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31/Day 1 | 162 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Dy 4/Day 1 | 0.98 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31/Day 1 | 216 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Dy 4/Day 1 | 0.80 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 8/Day 1 | 1.21 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31/Day 1 | 2.11 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4/Day 1 | 1.06 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8/Day 1 | 1.69 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31/Day 1 | 2.80 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4/Day 1 | 1.19 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8/Day 1 | 1.31 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31/Day 1 | 2.64 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 4/Day 1 | 0.93 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 8/Day 1 | 1.22 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31/Day 1 | 2.15 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 4/Day 1 | 1.00 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 8/Day 1 | 1.73 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31/Day 1 | 4.78 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 4/Day 1 | 0.93 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 8/Day 1 | 1.30 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31/Day 1 | 11 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 4/Day 1 | 0.87 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 8/Day 1 | 17 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31/Day 1 | 22 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 4/Day 1 | 1.20 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 8/Day 1 | 491 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31/Day 1 | 238 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 4/Day 1 | 0.97 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 8/Day 1 | 67 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31/Day 1 | 112 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 4/Day 1 | 0.73 Ratios |
| MenACWY Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 8/Day 1 | 132 Ratios |
Secondary
GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMRs as measure of the kinetics of the immune response following a dose of MenABCWY+OMV, in Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Days 31, 34, 38 and 61 versus Day 1.
Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 31/Day 1 | 2.72 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 34/Day 1 | 3.45 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 38/Day 1 | 6.15 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459; Day 61/Day 1 | 6.78 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31/Day 1 | 2.48 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 34/Day 1 | 3.97 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 38/Day 1 | 64 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61/Day 1 | 18 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31/Day 1 | 3.98 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 34/Day 1 | 4.52 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 38/Day 1 | 5.84 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61/Day 1 | 5.28 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 31/Day 1 | 2.48 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 34/Day 1 | 2.54 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 38/Day 1 | 2.83 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713; Day 61/Day 1 | 2.85 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 31/Day 1 | 5.06 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 34/Day 1 | 6.17 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 38/Day 1 | 24 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76; Day 61/Day 1 | 23 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 31/Day 1 | 13 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 34/Day 1 | 20 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 38/Day 1 | 233 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99; Day 61/Day 1 | 141 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 31/Day 1 | 18 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 34/Day 1 | 28 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 38/Day 1 | 82 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A; Day 61/Day 1 | 61 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 31/Day 1 | 12 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 34/Day 1 | 18 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 38/Day 1 | 64 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C; Day 61/Day 1 | 39 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 31/Day 1 | 16 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 34/Day 1 | 42 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 38/Day 1 | 16 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W; Day 61/Day 1 | 22 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 31/Day 1 | 46 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 34/Day 1 | 69 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 38/Day 1 | 134 Ratios |
| MenABCWY+OMV Group | GMR Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y; Day 61/Day 1 | 106 Ratios |
Secondary
GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMRs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: Day 61 versus Day 1 (baseline)
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 3.50 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 16 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 4.61 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 2.70 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 16 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 110 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 33 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 181 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 85 Ratios |
| MenABCWY+OMV Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 264 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 39 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 6.78 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 141 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 18 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 106 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 5.28 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 61 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 2.85 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 22 Ratios |
| MenACWY Group | GMRs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 23 Ratios |
Secondary
GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
GMTs as measure of the immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 61
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 4.82 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 19 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 6.24 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 6.91 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 19 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 196 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 222 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 879 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 1440 Titers |
| MenABCWY+OMV Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 1576 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup C | 188 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M14459 | 9.78 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, 5/99 | 256 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M01-0240364 | 21 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup Y | 224 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, NZ98/254 | 7.50 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup A | 74 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, M10713 | 8.73 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup W | 168 Titers |
| MenACWY Group | GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains. | Serogroup B, H44/76 | 32 Titers |
Comparison: Between-group GMT ratios against N. meningitidis Serogroup B, M1445995% CI: [0.28, 0.87]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis Serogroup B, M01-024036495% CI: [0.4, 2.11]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup B, NZ98/25495% CI: [0.5, 1.38]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup B, M1071395% CI: [0.44, 1.44]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup B, H44/7695% CI: [0.34, 1.07]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup B, 5/9995% CI: [0.52, 1.12]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup A95% CI: [1.89, 4.75]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup C95% CI: [3.01, 7.31]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup W95% CI: [5.84, 13]Miettinen & Nurminen score method
Comparison: Between-group GMT ratios against N. meningitidis serogroup Y95% CI: [3.96, 12]Miettinen & Nurminen score method
Secondary
Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination
Any solicited and unsolicited AEs reported within 30 minutes after each vaccination. Assessed solicited local symptoms were: Erythema and Induration. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site. Assessed solicited general symptoms were: Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of Pain and/or Fever and Treatment of Pain and/or Fever. Any = occurrence of the symptom regardless of intensity grade. Note: There were no unsolicited AEs reported within 30 minutes after vaccination.
Time frame: Within 30 min after each vaccination
Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Chills (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Nausea (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Erythema (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Loss of Appetite (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Arthralgia (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fatigue (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Treatment of Pain/Fever (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Myalgia (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Induration (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Pain (1st vaccination) | 4 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Headache (1st vaccination) | 1 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Prevention of Pain/Fever (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fever (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Prevention of Pain/Fever (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Myalgia (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Treatment of Pain/Fever (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Treatment of Pain/Fever (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Induration (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Chills (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Chills (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Induration (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fatigue (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Erythema (1st vaccination) | 1 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fatigue (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Headache (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Headache (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Pain (1st vaccination) | 8 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Myalgia (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Loss of Appetite (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Pain (2nd vaccination) | 3 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Loss of Appetite (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Nausea (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Erythema (2nd vaccination) | 1 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Nausea (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fever (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Arthralgia (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fever (2nd vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Prevention of Pain/Fever (1st vaccination) | 0 Subjects |
| MenACWY Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Arthralgia (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Headache (2nd vaccination) | 1 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Myalgia (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Erythema (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Erythema (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Induration (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Induration (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Pain (1st vaccination) | 6 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Pain (2nd vaccination) | 4 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Arthralgia (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Myalgia (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Arthralgia (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Chills (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Chills (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fatigue (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fatigue (2nd vaccination) | 1 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Headache (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Loss of Appetite (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Loss of Appetite (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Nausea (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Nausea (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fever (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Fever (2nd vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Prevention of Pain/Fever (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Prevention of Pain/Fever (2nd vaccination) | 1 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Treatment of Pain/Fever (1st vaccination) | 0 Subjects |
| Naive Group | Number of Subjects Reporting Any Unsolicited and Solicited Adverse Events (AEs) Within 30 Min After Each Vaccination | Treatment of Pain/Fever (2nd vaccination) | 2 Subjects |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were Erythema, Induration and Pain. Any = occurrence of the symptom spreading beyond 25 millimeters (mm) of injection site.
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Any Solicited Local Symptoms | Any local AEs (1st vaccination) | 31 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Any Solicited Local Symptoms | Pain (1st vaccination) | 31 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Any Solicited Local Symptoms | Induration (1st vaccination) | 12 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Any Solicited Local Symptoms | Erythema (1st vaccination) | 8 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Pain (1st vaccination) | 41 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Any local AEs (1st vaccination) | 41 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Erythema (1st vaccination) | 7 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Induration (1st vaccination) | 7 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Any local AEs (2nd vaccination) | 35 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Erythema (2nd vaccination) | 6 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Induration (2nd vaccination) | 9 Subjects |
| MenACWY Group | Number of Subjects With Any Solicited Local Symptoms | Pain (2nd vaccination) | 34 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Pain (2nd vaccination) | 41 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Any local AEs (2nd vaccination) | 41 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Induration (2nd vaccination) | 8 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Erythema (2nd vaccination) | 7 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Induration (1st vaccination) | 13 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Erythema (1st vaccination) | 8 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Any local AEs (1st vaccination) | 47 Subjects |
| Naive Group | Number of Subjects With Any Solicited Local Symptoms | Pain (1st vaccination) | 47 Subjects |
Secondary
Number of Subjects With Medically Attended AEs Reported During the Entire Study Period.
Medically attended AEs = were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) = Occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination.
Time frame: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Medically Attended AEs Reported During the Entire Study Period. | 2 Subjects |
| MenACWY Group | Number of Subjects With Medically Attended AEs Reported During the Entire Study Period. | 6 Subjects |
| Naive Group | Number of Subjects With Medically Attended AEs Reported During the Entire Study Period. | 5 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Possibly or probably related SAE(s) = SAE(s) assessed by the investigator as related to the vaccination.
Time frame: During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Any SAEs | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | AEs leading to death | 0 Subjects |
| MenACWY Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
| MenACWY Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Any SAEs | 0 Subjects |
| MenACWY Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | AEs leading to death | 0 Subjects |
| Naive Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Any SAEs | 0 Subjects |
| Naive Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | AEs leading to death | 0 Subjects |
| Naive Group | Number of Subjects With Serious Adverse Events (SAEs) Reported During the Entire Study Period. | Possibly or probably related SAEs | 0 Subjects |
Secondary
Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data
Assessed solicited systemic symptoms were Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea and Fever (body temperature ≥ 38°C). Other solicited data included: Prevention of pain and/or fever and Treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 1 (6 hours) to Day 7 after each vaccination
Population: Analysis was performed on Solicited safety Set- included all subjects in the Full Analysis Set Immunogenicity population who provided post-vaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Headache (1st vaccination) | 19 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Arthralgia (1st vaccination) | 8 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Chills (1st vaccination) | 5 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fatigue (1st vaccination) | 14 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Any systemic AEs (1st vaccination) | 24 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Loss of Appetite (1st vaccination) | 5 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Myalgia (1st vaccination) | 18 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Nausea (1st vaccination) | 4 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fever (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Prevention of Pain/Fever (1st vaccination) | 0 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Treatment of Pain/Fever (1st vaccination) | 8 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Prevention of Pain/Fever (2nd vaccination) | 1 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Headache (1st vaccination) | 20 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fever (2nd vaccination) | 4 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Loss of Appetite (1st vaccination) | 9 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Myalgia (1st vaccination) | 22 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Nausea (1st vaccination) | 10 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fever (1st vaccination) | 4 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Treatment of Pain/Fever (2nd vaccination) | 2 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Prevention of Pain/Fever (1st vaccination) | 1 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Treatment of Pain/Fever (1st vaccination) | 7 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Any systemic AEs (2nd vaccination) | 22 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Arthralgia (2nd vaccination) | 4 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Chills (2nd vaccination) | 5 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fatigue (2nd vaccination) | 10 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Headache (2nd vaccination) | 11 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Loss of Appetite (2nd vaccination) | 3 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Any systemic AEs (1st vaccination) | 35 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Myalgia (2nd vaccination) | 12 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Arthralgia (1st vaccination) | 8 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Chills (1st vaccination) | 11 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Nausea (2nd vaccination) | 4 Subjects |
| MenACWY Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fatigue (1st vaccination) | 19 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Chills (1st vaccination) | 11 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Nausea (2nd vaccination) | 4 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Any systemic AEs (2nd vaccination) | 28 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Headache (1st vaccination) | 23 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Loss of Appetite (2nd vaccination) | 5 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Arthralgia (2nd vaccination) | 7 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Loss of Appetite (1st vaccination) | 9 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fever (2nd vaccination) | 2 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Arthralgia (1st vaccination) | 15 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Myalgia (1st vaccination) | 23 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fatigue (1st vaccination) | 24 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Chills (2nd vaccination) | 9 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Nausea (1st vaccination) | 13 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Prevention of Pain/Fever (2nd vaccination) | 3 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Any systemic AEs (1st vaccination) | 37 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fever (1st vaccination) | 8 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Fatigue (2nd vaccination) | 12 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Myalgia (2nd vaccination) | 14 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Prevention of Pain/Fever (1st vaccination) | 1 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Treatment of Pain/Fever (2nd vaccination) | 6 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Headache (2nd vaccination) | 18 Subjects |
| Naive Group | Number of Subjects With Solicited Systemic Symptoms and Other Solicited Data | Treatment of Pain/Fever (1st vaccination) | 11 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Possibly or Probably related = AE assessed by the investigator as related to the vaccination.
Time frame: From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Possibly or Probably Related AEs | 3 Subjects |
| MenABCWY+OMV Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 11 Subjects |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Possibly or Probably Related AEs | 11 Subjects |
| MenACWY Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 21 Subjects |
| Naive Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Any AEs | 20 Subjects |
| Naive Group | Number of Subjects With Unsolicited Adverse Events (AEs). | Possibly or Probably Related AEs | 8 Subjects |
Secondary
Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period.
The number of subjects who reported unsolicited AEs leading to premature withdrawal from study after any vaccination.
Time frame: From Day 1 to Day 31 (MenABCWY+OMV Group) and from Day 1 to Day 61 (MenACWY and Naive Groups)
Population: Analysis was performed on Unsolicited Safety Set- included all subjects in the Exposed Set who had post-vaccination unsolicited adverse event records.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenABCWY+OMV Group | Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period. | 0 Subjects |
| MenACWY Group | Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period. | 1 Subjects |
| Naive Group | Number of Subjects With Unsolicited AEs Leading to Premature Withdrawal From Study Reported During the Entire Study Period. | 0 Subjects |
Secondary
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of Subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Days 1, 4, 8, 31, 34, 38 and 61
Population: Kinetics of immune response against N. meningitidis serogroup B test strains in previously vaccinated subjects, at Day 1, 4, 8, 31, as measured by the percentages of Subjects with hSBA ≥ 5. The data were reported based on the FAS immunogenicity kinetics population set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4 | 12 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4 | 17 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8 | 93 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 15 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 97 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 18 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 8 | 79 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 70 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 85 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 8 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 97 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 8 | 94 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 4 | 21 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 27 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 85 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 4 | 79 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 8 | 79 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 4 | 56 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 48 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 13 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 4 | 21 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 82 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8 | 67 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 29 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 9 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 4 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 35 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 61 | 43 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 9 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 4 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61 | 65 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 4 | 13 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 48 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61 | 52 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 48 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 4 | 39 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 70 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 61 | 65 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 9 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 4 | 4 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 52 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 61 | 78 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 22 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 4 | 9 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 78 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 26 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 8 | 14 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61 | 39 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 61 | 91 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 78 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 61 | 43 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 52 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 8 | 10 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61 | 65 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 8 | 9 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 27 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 8 | 14 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 17 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 8 | 9 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 22 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 61 | 48 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 8 | 32 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 13 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 0 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 35 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 4 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 58 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 34 | 50 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 8 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61 | 72 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 38 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 61 | 80 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 61 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 62 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 34 | 57 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 61 | 68 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 34 | 42 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 85 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 12 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 46 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 34 | 85 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 73 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 34 | 69 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 61 | 96 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 33 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 34 | 40 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 19 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61 | 70 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 8 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 38 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 38 | 67 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 38 | 75 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 61 | 79 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 31 | 54 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 61 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 38 | 71 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 1 | 38 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 31 | 46 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 31 | 24 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 1 | 4 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 38 | 82 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 1 | 4 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 61 | 54 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 31 | 79 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 1 | 8 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459; Day 31 | 33 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 1 | 8 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364; Day 61 | 71 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713; Day 61 | 63 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254; Day 61 | 50 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 31 | 46 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99; Day 1 | 13 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76; Day 38 | 96 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains.
Immunogenicity against N. meningitidis serogroup B test strains following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 5. The Meningococcal B Strains were M14459, M01-0240364, NZ98/254, M10713, H44/76 and 5/99.
Time frame: At Day 61
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 46 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 65 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 46 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 54 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 85 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, H44/76 | 88 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M14459 | 67 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M10713 | 65 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, M01-0240364 | 70 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, 5/99 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 5 Against N. Meningitidis Serogroup B Test Strains. | Serogroup B, NZ98/254 | 61 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Kinetics of immune response following 1 dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY, at Days 1, 4, 8, 31, 34, 38 and 61, as measured by the percentages of subjects with hSBA ≥ 8.
Time frame: At Days 1, 4, 8, 31, 34, 38 and 61
Population: Analysis was performed on Full Analysis Set immunogenicity kinetics population set- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample post vaccination and whose assay result was available for at least one strain.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 4 | 42 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 31 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 8 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 4 | 73 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 1 | 69 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 4 | 24 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 31 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 8 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 1 | 38 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 31 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 8 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 1 | 27 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 31 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 8 | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 4 | 76 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 1 | 75 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 31 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 1 | 52 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 4 | 52 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 31 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 61 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 1 | 61 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 4 | 64 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 31 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 61 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 1 | 70 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 4 | 73 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 61 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 1 | 64 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 4 | 50 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 31 | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 8 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 31 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 31 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 8 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 1 | 26 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 1 | 55 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 8 | 82 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 1 | 87 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 31 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 1 | 30 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 61 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 31 | 100 Percentages of subjects |
| Naive Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 8 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 1 | 0 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 34 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 31 | 91 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 61 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 1 | 44 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 34 | 77 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 34 | 96 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 31 | 73 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 31 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 34 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 61 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 1 | 17 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 31 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 1 | 40 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 61 | 100 Percentages of subjects |
| Naive Group (C1) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 61 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 1 | 21 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 1 | 4 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 31 | 92 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 38 | 96 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 31 | 79 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 1 | 64 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 31 | 78 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 61 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 1 | 50 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A; Day 61 | 88 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 38 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 61 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 38 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y; Day 61 | 95 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W; Day 38 | 100 Percentages of subjects |
| Naive Group (C2) | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C; Day 31 | 87 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y.
Immunogenicity against N. meningitidis serogroup A, C, W and Y following 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY and Naïve subjects, at Day 61, as measured by percentages of subjects with hSBA ≥ 8.
Time frame: At Day 61
Population: Analysis was performed on Full Analysis Set immunogenicity persistence population set Day 61- all subjects in the enrolled population who received a study vaccination, provided at least one evaluable serum sample at 1 month post second vaccination and whose assay result was available for at least one serogroup/ test strain
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 100 Percentages of subjects |
| MenABCWY+OMV Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup Y | 98 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup A | 94 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup W | 100 Percentages of subjects |
| MenACWY Group | Percentages of Subjects With hSBA ≥ 8 Against N. Meningitidis Serogroups A, C, W and Y. | Serogroup C | 100 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 19 and 20 and are considered final in Company's judgement.
Time frame: At Day 61
Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.
Secondary
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.
Time frame: At Days 1, 4, 8 and 31
Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.
Secondary
Percentages of Subjects With hSBA ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains.
The HT-hSBA assay format was changed in 2015 in response to CBER comments and no new LLQ values were defined as the validation of this format was not relevant. The LLQ cut off values for the old assay format correspond to 8 for serogroups A,C,W and Y and 5 for serogroup B strains and these results are presented in outcome measures 12 and 13 and are considered final in Company's judgement.
Time frame: At Days 1, 31, 34, 38 and 61
Population: Data was not collected for this outcome measure as validation procedure of the hSBA assay was not relevant to the study.