Meningococcal Disease
Conditions
Keywords
Meningococcal, Booster, MenABCWY, Menveo, Vaccine Adolescents, Immune Response, N. Meningitidis
Brief summary
The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects. In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102\_03E1.
Interventions
BIOLOGICALMenABCWY+OMV
Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a full dose) plus the fully lyophilized MenACWY vaccine
BIOLOGICALMenABCWY+¼OMV
Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
BIOLOGICALPlacebo
Saline solution for injection (0.5mL)
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102\_03 (NCT01272180); 2. Individuals or the individual's parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements; 3. Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements; 4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; 5. Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.
Exclusion criteria
1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102\_03 (NCT01272180); 2. Current or previous, confirmed or suspected disease caused by N. meningitidis; 3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment; 4. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 5. All sexually active females that have not used an acceptable contraceptive method(s) for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following: 1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring) 2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse 3. Intrauterine device (IUD) 4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry; 6. Sexually active females that refuse to use to an acceptable contraceptive method through to 3 weeks following the study vaccination; 7. Female subjects with a positive pregnancy test prior to the study vaccine being administered; 8. Nursing (breastfeeding) mothers; 9. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study; 10. Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition); 11. Subjects who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 20mg/day. Inhaled and topical steroids are allowed). 12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days; 13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study; 14. Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered \>14 days preceding or \>14 days following the study vaccination); 15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse. 16. Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment. 17. Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Day 30 | Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer. |
| 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | Day 1 and Day 30 | Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Day 1 (Pre-vaccination) | The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180). |
| 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | Day 1 (Pre-vaccination) | The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180). |
| 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Day 1 and Day 30 | The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. |
| 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | Day 1 and Day 30 | The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. |
| 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | Day 1 and Day 30 | Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase. |
| 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Day 1 and Day 30 | Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline. |
| 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | Day 1 and Day 30 | Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline. |
| 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Day 30 | Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline. |
| 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Day 1 and Day 365 | Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination. |
| 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | Day 1, Day 30 and Day 365 | Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination. |
| 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | Day 1, Day 30 and Day 365 | Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase. |
| 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Day 1 (Pre vaccination) | Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180). |
| 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | Day 1 and Day 365 | The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination. |
| 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Day 1, Day 30 and Day 365 | Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. |
| 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | Day 1, Day 30 and Day 365 | Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. |
| 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Day 1, Day 30 and Day 365 | The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. |
| 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | Day 1, Day 30 and Day 365 | The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination. |
| 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Day 1, Day 30 and Day 365 | Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study. |
| 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | From day 1 (6 hours) through day 7 after any vaccination | Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever. |
| 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Day 1 through Day 30 | Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30. |
| 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Day 1 to Day 365 | Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period. |
| 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | From primary parent study completion up to Day 1 in this study. | Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102\_03 (NCT01272180) up to Day 1 visit in V102\_03E1 study, is reported. (Any NOCD AEs: NOCD V102\_03 (NCT01272180) vs. NOCD- Day 1, V102\_03E1) |
| 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Day 1 and Day 365 | The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination. |
| 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | Day 1 (Pre vaccination) | Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180). |
Countries
Poland, United States
Participant flow
Recruitment details
Subjects were recruited from 5 study sites in Poland and from 8 study sites in United States.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| 2OMV_OMV Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study. | 26 |
| 2OMV_Pbo Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study. | 25 |
| 2qOMV_qOMV Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study. | 17 |
| 2qOMV_Pbo Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study. | 24 |
| 2B_OMV Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study. | 11 |
| 2B_qOMV Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study. | 21 |
| 2B_Pbo Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study. | 7 |
| 1M_OMV Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study. | 21 |
| 1M_qOMV Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study. | 19 |
| 1M_Pbo Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study. | 19 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Administrative Reason | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 2OMV_OMV | 2OMV_Pbo | 2qOMV_qOMV | 2qOMV_Pbo | 2B_OMV | 2B_qOMV | 2B_Pbo | 1M_OMV | 1M_qOMV | 1M_Pbo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 18.8 Years STANDARD_DEVIATION 5.19 | 17.1 Years STANDARD_DEVIATION 4.31 | 18 Years STANDARD_DEVIATION 5.05 | 19 Years STANDARD_DEVIATION 5.4 | 20.9 Years STANDARD_DEVIATION 3.99 | 19.7 Years STANDARD_DEVIATION 5.36 | 17.9 Years STANDARD_DEVIATION 4.67 | 16.8 Years STANDARD_DEVIATION 4.65 | 19.2 Years STANDARD_DEVIATION 6.1 | 17.6 Years STANDARD_DEVIATION 5.19 | 18.4 Years STANDARD_DEVIATION 5.08 |
| Sex/Gender, Customized Female | 8 Participants | 13 Participants | 9 Participants | 14 Participants | 2 Participants | 15 Participants | 3 Participants | 12 Participants | 12 Participants | 11 Participants | 99 Participants |
| Sex/Gender, Customized Male | 18 Participants | 12 Participants | 8 Participants | 10 Participants | 9 Participants | 6 Participants | 4 Participants | 9 Participants | 7 Participants | 8 Participants | 91 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 25 / 26 | 16 / 24 | 16 / 17 | 15 / 23 | 11 / 11 | 19 / 21 | 4 / 6 | 20 / 21 | 17 / 19 | 15 / 19 | 158 / 188 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 1 / 17 | 1 / 23 | 0 / 11 | 1 / 21 | 0 / 6 | 0 / 21 | 1 / 19 | 1 / 19 | 5 / 188 |
Outcome results
Primary
1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.
Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer \< 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time frame: Day 30
Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men A | 96 Percentages of Subjects |
| 2OMV_OMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men W (N=20,13) | 85 Percentages of Subjects |
| 2OMV_OMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men C (N=20,10) | 85 Percentages of Subjects |
| 2OMV_OMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men Y (N=25,14) | 96 Percentages of Subjects |
| 2qOMV_qOMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men C (N=20,10) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men A | 94 Percentages of Subjects |
| 2qOMV_qOMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men Y (N=25,14) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y. | Men W (N=20,13) | 85 Percentages of Subjects |
Primary
2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.
Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102\_03 (NCT01272180).
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | 5/99 (Day 1, N= 25,15) | 76 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | 5/99 (Day 30, N=25,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | H44/76 (Day 1, N=25,16) | 16 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | H44/76 (Day 30, N=25,17) | 96 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M01-0240364 (Day 1, N=24,15) | 25 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M01-0240364 (Day 30, N=25,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M07-0241084 (Day 1,N=25,15) | 36 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M07-0241084 (Day 30, N=25,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M14459 (Day 1, N=25,15) | 24 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M14459 (Day 30, N=25,17) | 92 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | NZ98/254 (Day 1, N=25,15) | 16 Percentages of Subjects |
| 2OMV_OMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | NZ98/254 (Day 30, N=25,17) | 92 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | NZ98/254 (Day 1, N=25,15) | 7 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | 5/99 (Day 1, N= 25,15) | 87 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M07-0241084 (Day 1,N=25,15) | 27 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | 5/99 (Day 30, N=25,17) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M14459 (Day 30, N=25,17) | 88 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | H44/76 (Day 1, N=25,16) | 13 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M07-0241084 (Day 30, N=25,17) | 88 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | H44/76 (Day 30, N=25,17) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | NZ98/254 (Day 30, N=25,17) | 71 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M01-0240364 (Day 1, N=24,15) | 20 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M14459 (Day 1, N=25,15) | 7 Percentages of Subjects |
| 2qOMV_qOMV | 2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B. | M01-0240364 (Day 30, N=25,17) | 100 Percentages of Subjects |
Secondary
10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 70 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 32 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 95 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 64 Percentages of Subjects |
| 2OMV_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 63 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 36 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 64 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 65 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 79 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 20 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 60 Percentages of Subjects |
| 2qOMV_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 88 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 100 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 100 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 100 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 64 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 70 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 19 Percentages of Subjects |
| rMenB+OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 77 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 27 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 41 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 39 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 68 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 61 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 71 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 27 Percentages of Subjects |
| Menveo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 77 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 82 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 100 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 82 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 100 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 36 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 43 Percentages of Subjects |
| 2B_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 27 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 95 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 76 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 63 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 10 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 79 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 100 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| 2B_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 33 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 100 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 47 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 57 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 83 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 100 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 100 Percentages of Subjects |
| 1M_OMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 52 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 6 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 94 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 44 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 89 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 53 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 100 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 100 Percentages of Subjects |
| 1M_qOMV | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 39 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 39 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 39 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 63 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 53 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 61 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 39 Percentages of Subjects |
| 1M_Pbo | 10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 39 Percentages of Subjects |
Secondary
11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 96 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 92 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 16 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 76 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 16 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 24 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 36 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 92 Percentages of Subjects |
| 2OMV_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 25 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 24 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 28 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 76 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 84 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 24 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 24 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 24 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 36 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 40 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 20 Percentages of Subjects |
| 2qOMV_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 28 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 88 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 27 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 100 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 88 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 100 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 71 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 13 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 7 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 7 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 20 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 100 Percentages of Subjects |
| rMenB+OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 87 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 30 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 27 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 86 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 9 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 18 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 91 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 5 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 13 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 18 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 17 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 26 Percentages of Subjects |
| Menveo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 30 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 9 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 45 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 20 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 89 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 64 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 91 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 36 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 82 Percentages of Subjects |
| 2B_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 100 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 95 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 95 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 24 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 29 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 43 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 95 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 100 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 100 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 29 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 95 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 52 Percentages of Subjects |
| 2B_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 100 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 19 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 76 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 19 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 5 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 33 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 35 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 19 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 10 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 58 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 5 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 0 Percentages of Subjects |
| 1M_OMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 25 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 32 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 6 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 5 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 26 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 5 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 16 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 32 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 16 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 84 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 21 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 16 Percentages of Subjects |
| 1M_qOMV | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 11 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1,N=25,25,15,22,11,21,21,19,18) | 33 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,17,23,11,21,19,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 11 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=25,25,15,23,11,21,21,19,18) | 0 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 22 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 22 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 22 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=25,25,16,22,11,21,19,19,18) | 0 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,17,23,11,21,21,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 11 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 22 Percentages of Subjects |
| 1M_Pbo | 11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,17,23,11,21,21,19,18) | 33 Percentages of Subjects |
Secondary
12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.
Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.
Time frame: Day 30
Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 85 Percentages of Subjects |
| 2OMV_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 96 Percentages of Subjects |
| 2OMV_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 96 Percentages of Subjects |
| 2OMV_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 85 Percentages of Subjects |
| 2qOMV_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 4 Percentages of Subjects |
| 2qOMV_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 12 Percentages of Subjects |
| 2qOMV_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 4 Percentages of Subjects |
| 2qOMV_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 4 Percentages of Subjects |
| rMenB+OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 100 Percentages of Subjects |
| rMenB+OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 94 Percentages of Subjects |
| rMenB+OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 85 Percentages of Subjects |
| rMenB+OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 100 Percentages of Subjects |
| Menveo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 5 Percentages of Subjects |
| Menveo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 0 Percentages of Subjects |
| Menveo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 0 Percentages of Subjects |
| Menveo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 0 Percentages of Subjects |
| 2B_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 82 Percentages of Subjects |
| 2B_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 100 Percentages of Subjects |
| 2B_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 73 Percentages of Subjects |
| 2B_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 100 Percentages of Subjects |
| 2B_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 68 Percentages of Subjects |
| 2B_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 81 Percentages of Subjects |
| 2B_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 62 Percentages of Subjects |
| 2B_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 86 Percentages of Subjects |
| 1M_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 95 Percentages of Subjects |
| 1M_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 95 Percentages of Subjects |
| 1M_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 84 Percentages of Subjects |
| 1M_OMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 83 Percentages of Subjects |
| 1M_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 76 Percentages of Subjects |
| 1M_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 94 Percentages of Subjects |
| 1M_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 89 Percentages of Subjects |
| 1M_qOMV | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 78 Percentages of Subjects |
| 1M_Pbo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men Y Overall | 6 Percentages of Subjects |
| 1M_Pbo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men C Overall | 6 Percentages of Subjects |
| 1M_Pbo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men A Overall | 0 Percentages of Subjects |
| 1M_Pbo | 12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study. | Men W Overall | 20 Percentages of Subjects |
Secondary
13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.
Time frame: Day 1 and Day 365
Population: Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 95 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 67 Percentages of Subjects |
| 2OMV_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 38 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 82 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 52 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 23 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 68 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 71 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 71 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 88 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 20 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 50 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 70 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| Menveo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 25 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 82 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 91 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 45 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 36 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 90 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| 2B_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 36 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 72 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 35 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 95 Percentages of Subjects |
| 2B_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 11 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 45 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 55 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 61 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 50 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 12 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 89 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 89 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 44 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_qOMV | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 50 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 35 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 41 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 56 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 41 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 75 Percentages of Subjects |
| 1M_Pbo | 13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 47 Percentages of Subjects |
Secondary
14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 29 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 76 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 95 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 24 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 71 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 57 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 24 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 62 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 38 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 76 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 19 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 19 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 77 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 45 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 14 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 86 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 23 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 82 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 27 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 27 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 27 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 27 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 41 Percentages of Subjects |
| 2qOMV_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 36 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 44 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 100 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 86 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 7 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 100 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 94 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 38 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 50 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 7 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 21 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 29 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 100 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 13 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 88 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 31 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 75 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 75 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 80 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 10 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 6 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 20 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 25 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 6 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 20 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 15 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 15 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 5 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 15 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 90 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 6 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 25 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 5 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 10 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 85 Percentages of Subjects |
| Menveo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 5 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 64 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 9 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 36 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 20 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 89 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 91 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 82 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 82 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 45 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 45 Percentages of Subjects |
| 2B_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 82 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 26 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 95 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 100 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 100 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 30 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 100 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 65 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 42 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 100 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 95 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 58 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 95 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 74 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 30 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 95 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 60 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 95 Percentages of Subjects |
| 2B_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 42 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 76 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 35 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 5 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 19 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 43 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 19 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 19 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 14 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 19 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 15 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 33 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 19 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 58 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 29 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 10 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 5 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 5 Percentages of Subjects |
| 1M_OMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 21 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 6 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 33 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 83 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 6 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 17 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 17 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 33 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 22 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 17 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 11 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 6 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 17 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 11 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 11 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 11 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 33 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 28 Percentages of Subjects |
| 1M_qOMV | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 24 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 35 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364(Day 365, N=21,22,16,18,11,19,20,18,17) | 18 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 24 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 13 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 12 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 25 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084(Day 365, N=21,22,16,20,11,19,21,18,17) | 35 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 0 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 18 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 25 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 24 Percentages of Subjects |
| 1M_Pbo | 14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 38 Percentages of Subjects |
Secondary
15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 60 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 81 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 19 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 81 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 67 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 76 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 55 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 62 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 81 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 95 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 38 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 100 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 79 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 24 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 10 Percentages of Subjects |
| 2OMV_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 30 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 5 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 76 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 5 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 55 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 20 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 5 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 5 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 5 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 52 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 95 Percentages of Subjects |
| 2qOMV_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 0 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 93 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 67 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 86 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 93 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 53 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 93 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 86 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 100 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 93 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 100 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 67 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 20 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 71 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 14 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 64 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 33 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 0 Percentages of Subjects |
| rMenB+OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 58 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 67 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 100 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 6 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 58 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 17 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 95 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 6 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 5 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 0 Percentages of Subjects |
| Menveo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 0 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 45 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 82 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 91 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 9 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 91 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 55 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 89 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 90 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 27 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 36 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 100 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 91 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 100 Percentages of Subjects |
| 2B_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 64 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 75 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 5 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 89 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 30 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 63 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 67 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 63 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 58 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 75 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 100 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 25 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 5 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 94 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 89 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 79 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 74 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 56 Percentages of Subjects |
| 2B_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 89 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 10 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 57 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 29 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 37 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 19 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 10 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 15 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 14 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 15 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 10 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_OMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 16 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 6 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 28 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 24 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 28 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 6 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 78 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 6 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 0 Percentages of Subjects |
| 1M_qOMV | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 365, N=21,22,15,20,11,20,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30, N=21,22,14,20,11,19,21,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=20,20,15,18,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 365,N=21,22,14,18,10,19,20,17,17) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 365, N=21,22,14,20,11,20,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 30, N=21,22,14,17,10,19,19,17,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 365, N=21,22,14,20,11,19,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=21,22,14,20,11,19,21,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=21,22,14,20,11,20,20,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=21,22,15,20,11,20,19,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=20,22,15,20,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 365, N=21,22,14,20,9,19,21,18,17) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=19,21,15,15,11,18,6,4,4) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=21,22,14,20,9,19,21,18,16) | 6 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 20,21,15,19,11,18,6,4,5) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=20,22,15,19,11,19,6,4,5) | 0 Percentages of Subjects |
| 1M_Pbo | 15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 365,N=21,22,14,20,11,19,21,18,17) | 6 Percentages of Subjects |
Secondary
16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.
Time frame: Day 1 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 18 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 25 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 3.98 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 128 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 36 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 190 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 10 Titers |
| 2OMV_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 116 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 15 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 2.62 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 16 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 19 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 28 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 2.73 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 18 Titers |
| 2qOMV_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 43 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 235 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 177 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 213 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 44 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 24 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 19 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 3.07 Titers |
| rMenB+OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 30 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 3.03 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 5.39 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 5.93 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 10 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 9.14 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 17 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 2.98 Titers |
| Menveo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 16 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 25 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 29 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 7.17 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 80 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 54 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 2.40 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 5.20 Titers |
| 2B_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 2.27 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 53 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 20 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 7.83 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 1.90 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 23 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 32 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 96 Titers |
| 2B_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 4.22 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 193 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 6.31 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 7.89 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 172 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 28 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 81 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 34 Titers |
| 1M_OMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 7.05 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 2.49 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 6.52 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 8.45 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 72 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 15 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 104 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 101 Titers |
| 1M_qOMV | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 6.83 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 9.56 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 7.03 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 16 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,22,12,20,11,20,17,18,16) | 10 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 24 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 24 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 3.54 Titers |
| 1M_Pbo | 16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=21,22,15,20,10,20,20,17,17) | 5.48 Titers |
Secondary
17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.
Time frame: Day 1 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 2.69 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 3.58 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.73 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 18 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 2.33 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 30 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 3.68 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 12 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 7.19 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 7.96 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 3.49 Titers |
| 2OMV_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 175 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 13 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 4.20 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 1.71 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 3.55 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.34 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 2.23 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 18 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.67 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.93 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 2.94 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 3.39 Titers |
| 2qOMV_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 3.28 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 2.94 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 74 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.28 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 4.19 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 4.09 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.34 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 2.87 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 31 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 305 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 2.67 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 1.49 Titers |
| rMenB+OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 1.54 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 1.73 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.47 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 1.23 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.83 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 2.01 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 1.23 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 2.04 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.36 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.48 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 23 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 1.26 Titers |
| Menveo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 31 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.72 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 27 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 587 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 3.45 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 21 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 2.46 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 303 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 4.10 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 10 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 3.11 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 11 Titers |
| 2B_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 3.28 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 7.12 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 3.43 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 39 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 11 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.24 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 3.37 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 7.35 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 6.29 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 491 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 3.77 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 11 Titers |
| 2B_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 155 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 2.97 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.08 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 1.24 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 2.45 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.96 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 1.65 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 1.85 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 1.34 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 2.09 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 6.05 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.18 Titers |
| 1M_OMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 1.61 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.92 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 1.19 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 1.91 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 1.71 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.38 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 4.23 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 1.24 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 2.15 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.19 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 1.80 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 1.48 Titers |
| 1M_qOMV | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 1.51 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364(Day 365,N= 21,22,16,18,11,19,20,18,17) | 2.03 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N= 21,22,14,20,11,20,21,18,16) | 2.55 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 1.13 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N= 21,22,14,20,9,19,21,18,17) | 3.20 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 21,22,15,20,11,20,21,18,17) | 1.19 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 2.17 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 2.45 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N= 21,22,16,20,11,19,21,18,17) | 1.28 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N= 21,22,14,18,10,19,20,17,17) | 1.68 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N= 21,22,16,20,11,20,21,18,17) | 1.49 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 3.92 Titers |
| 1M_Pbo | 17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 21,22,14,20,11,19,21,18,17) | 3.50 Titers |
Secondary
18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 38 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 95 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 67 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 68 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 82 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 52 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 86 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 65 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 57 Percentages of Subjects |
| 2qOMV_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 23 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 88 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 71 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 71 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 20 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| rMenB+OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 25 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 40 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 55 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 74 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 50 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 26 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 70 Percentages of Subjects |
| Menveo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 82 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 90 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 36 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 82 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 91 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 36 Percentages of Subjects |
| 2B_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 45 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 35 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 95 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 83 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 95 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 72 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 11 Percentages of Subjects |
| 2B_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 55 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 45 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 1M_OMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 89 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 94 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 50 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 12 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 44 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 61 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 88 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 50 Percentages of Subjects |
| 1M_qOMV | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 89 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 1,N=20,22,12,20,11,20,17,18,16) | 56 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 365, N=21,21,16,20,11,18,20,18,17) | 47 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 1, N=21,21,14,20,11,18,20,18,17) | 41 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 30, N=21,22,15,19,10,20,18,16,16) | 44 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 365, N=21,21,16,20,11,19,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 1,N=21,22,15,20,10,20,20,17,17) | 41 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 30, N=17,20,10,20,7,14,19,17,16) | 69 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men Y (Day 30, N=21,21,15,20,11,18,20,17,16) | 38 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men C (Day 1, N=20,19,14,20,11,19,19,18,16) | 75 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 365, N=21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men A (Day 365, N=21,22,16,20,10,20,20,18,17) | 35 Percentages of Subjects |
| 1M_Pbo | 18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y. | Men W (Day 30, N=18,22,15,19,11,18,17,16,14) | 57 Percentages of Subjects |
Secondary
19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 19 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 29 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 76 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 19 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 95 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 95 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 24 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 38 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 95 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 71 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 57 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 62 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 24 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 95 Percentages of Subjects |
| 2OMV_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 76 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 7 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 7 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 88 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 38 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 13 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 31 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 44 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 86 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 21 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 75 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 75 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 29 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 94 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 50 Percentages of Subjects |
| 2qOMV_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 82 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 64 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 20 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 89 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 82 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 82 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 36 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 45 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 45 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 91 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 82 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 9 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 100 Percentages of Subjects |
| rMenB+OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 100 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 95 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 100 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 42 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 100 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 95 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 30 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 60 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 95 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 95 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 58 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 26 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 42 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 74 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 100 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 30 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 65 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 95 Percentages of Subjects |
| Menveo | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 100 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 5 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 19 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 76 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 43 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 5 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 58 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 19 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 5 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 21 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 15 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 19 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 33 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 29 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 10 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 35 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 14 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 19 Percentages of Subjects |
| 2B_OMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 19 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 1, N= 21,14,11,20,21,18) | 11 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084(Day 365, N=21,16,11,19,21,18) | 17 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 30, N= 21,16,11,19,21,18) | 22 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (Day 1, N= 21,14,11,19,21,18) | 17 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 1,N= 21,14,9,19,21,18) | 17 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 1,N= 21,14,11,19,21,18) | 6 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 365, N= 21,16,11,19,20,18) | 11 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364(Day 30, N= 21,16,11,19,19,18) | 28 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (Day 1, N= 21,14,10,19,20,17) | 6 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 365, N= 21,16,11,20,21,18) | 11 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 365, N= 21,16,11,19,21,18) | 6 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (Day 30, N= 21,16,11,19,21,18) | 17 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 30, N= 21,16,11,20,19,18) | 33 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (Day 1, N= 21,15,11,20,21,18) | 6 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 365, 21,16,11,19,21,18) | 33 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 30, N= 21,16,11,20,20,18) | 33 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (Day 30, N= 21,16,11,19,21,18) | 83 Percentages of Subjects |
| 2B_qOMV | 19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (Day 365, N= 21,16,11,20,21,18) | 11 Percentages of Subjects |
Secondary
20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.
The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 737 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 275 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 190 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 128 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 844 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 3.98 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 25 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 444 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 36 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 18 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 10 Titers |
| 2OMV_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 116 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 2.62 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 21 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 17 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 18 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 3.88 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 16 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 43 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 2.73 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 46 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 28 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 15 Titers |
| 2qOMV_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 19 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 177 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 3.07 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 19 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 235 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 748 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 44 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 30 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 213 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 766 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 24 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 348 Titers |
| rMenB+OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 890 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 10 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 17 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 2.95 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 4.86 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 3.03 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 2.98 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 5.39 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 9.14 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 16 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 8.43 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 5.93 Titers |
| Menveo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 22 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 48 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 2.27 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 445 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 54 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 5.20 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 292 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 29 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 25 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 392 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 80 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 2.40 Titers |
| 2B_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 7.17 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 102 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 7.83 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 96 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 32 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 54 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 428 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 23 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 20 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 395 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 4.22 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 53 Titers |
| 2B_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 1.90 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 34 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 322 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 620 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 7.89 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 193 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 172 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 28 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 7.05 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 140 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 662 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 6.31 Titers |
| 1M_OMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 81 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 6.52 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 101 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 6.83 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 360 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 46 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 72 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 307 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 15 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 404 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 2.49 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 8.45 Titers |
| 1M_qOMV | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 104 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 1, N= 20,22,12,20,11,20,17,18,16) | 10 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 16 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 13 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 24 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 6.84 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 7.03 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 5.48 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 5.99 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 24 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 3.54 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 9.56 Titers |
| 1M_Pbo | 20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 27 Titers |
Secondary
21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 59 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.73 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 175 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 2.33 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 3.58 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 679 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 2.69 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 3.49 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 32 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 3.68 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 7.96 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 1147 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 30 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 39 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 18 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 7.19 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 104 Titers |
| 2OMV_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 12 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 3.39 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 2.94 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 3.57 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 3.28 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 23 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 4.37 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 13 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 18 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 1.71 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2.23 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 2.23 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.34 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.67 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 2.65 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 3.55 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 2.31 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.93 Titers |
| 2qOMV_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 4.2 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 2.94 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 2.87 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 36 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 4.19 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 57 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 1.54 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 4.09 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 20 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 74 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 1598 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 15 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 305 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.28 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 1.49 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 31 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.34 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 903 Titers |
| rMenB+OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 2.67 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 2.01 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 31 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 35 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 23 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 1.73 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 2.03 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.83 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 1.26 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 1.23 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 1.23 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 2.03 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.47 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.48 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 1.75 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.36 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 1.23 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2.2 Titers |
| Menveo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 2.04 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 10 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2205 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 587 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 17 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 56 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 3.11 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 11 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 303 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 68 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 132 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 21 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 1336 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 3.28 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 27 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 4.1 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.72 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 3.45 Titers |
| 2B_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 2.46 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.24 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 491 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2816 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 39 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 3.77 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 3.37 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 79 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 11 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 35 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 6.29 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 155 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 7.12 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 3.43 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 7.35 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 1261 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 66 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 11 Titers |
| 2B_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 28 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 1.34 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 28 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.96 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 2.68 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 1.85 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 1.65 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.18 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.08 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 3.26 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2.48 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 1.24 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 2.97 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 2.45 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 3.44 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 6.05 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 2.09 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 1.61 Titers |
| 1M_OMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 5.27 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 3.66 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.92 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 1.71 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 1.48 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 3.89 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 2.71 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 1.51 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.38 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 1.91 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.19 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 4.23 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 2.15 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 1.62 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 29 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 1.19 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 2.24 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 1.8 Titers |
| 1M_qOMV | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 1.24 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N=21,22,14,20,11,19,21,18,17) | 1.13 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 30, N=21,22,16,20,11,20,19,18,16) | 1.6 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 365, N=21,22,16,20,11,19,21,18,17) | 1.28 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 365,N=21,22,16,18,11,19,20,18,17) | 2.03 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=21,22,16,20,11,19,21,18,16) | 4.57 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 365, N=21,22,16,20,11,20,21,18,17) | 2.17 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=21,22,14,20,9,19,21,18,17) | 3.2 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 365, N=21,22,16,20,11,20,21,18,17) | 1.49 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=21,22,16,17,11,19,19,18,16) | 1.89 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=21,22,14,18,10,19,20,17,17) | 1.68 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N=21,22,15,20,11,20,21,18,17) | 1.19 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=21,22,16,20,11,20,20,18,16) | 3.05 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=21,22,14,20,11,20,21,18,17) | 2.55 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N=21,22,14,20,11,19,21,18,17) | 3.5 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=21,22,16,20,11,19,21,18,16) | 3.98 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N=21,22,16,20,11,19,21,18,16) | 1.73 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | M07-0241084 (Day 365,N=21,22,16,20,11,19,21,18,17) | 3.92 Titers |
| 1M_Pbo | 21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B. | 5/99 (Day 365, N=21,22,16,20,11,19,21,18,17) | 2.45 Titers |
Secondary
22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.
Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.
Time frame: Day 1, Day 30 and Day 365
Population: Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 365.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 38 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 95 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 67 Percentages of Subjects |
| 2OMV_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 52 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 95 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 23 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 57 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 32 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 62 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 68 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 82 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 65 Percentages of Subjects |
| 2qOMV_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 86 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 71 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 88 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 71 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 20 Percentages of Subjects |
| rMenB+OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 40 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 26 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 65 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 70 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 25 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 74 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 40 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 50 Percentages of Subjects |
| Menveo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 55 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 82 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 36 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 82 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 30 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 90 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 91 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 36 Percentages of Subjects |
| 2B_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 45 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 11 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 83 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 35 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 95 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 72 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 75 Percentages of Subjects |
| 2B_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 95 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 85 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 82 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 58 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 55 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 45 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 1M_OMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 100 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 94 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 89 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 50 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 89 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 44 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 100 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 88 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 61 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 100 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 12 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 100 Percentages of Subjects |
| 1M_qOMV | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 50 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 30, N= 21,22,15,19,10,20,18,16,16) | 44 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 365, N= 21,22,16,20,11,20,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 30, N= 21,21,15,20,11,18,20,17,16) | 38 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 1, N= 20,19,14,20,11,19,19,18,16) | 75 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 365, N= 21,22,16,20,10,20,20,18,17) | 35 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 1, N= 21,21,14,20,11,18,20,18,17) | 41 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 1, 20,22,12,20,11,20,17,18,16) | 56 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men A (Day 1, N= 21,22,15,20,10,20,20,17,17) | 41 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 365, N= 21,21,16,20,11,19,19,18,17) | 65 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men W (Day 30, N= 18,22,15,19,11,18,17,16,14) | 57 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men Y (Day 365, N= 21,21,16,20,11,18,20,18,17) | 47 Percentages of Subjects |
| 1M_Pbo | 22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination. | Men C (Day 30, N= 17,20,10,20,7,14,19,17,16) | 69 Percentages of Subjects |
Secondary
23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.
Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.
Time frame: From day 1 (6 hours) through day 7 after any vaccination
Population: Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 20 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 23 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 6 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 9 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 2 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 2 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 2 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 12 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 7 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 3 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 23 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 2 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 11 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 7 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| 2OMV_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 3 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 1 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 6 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 2 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 2 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 6 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 6 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 2 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 10 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 9 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 7 Participants |
| 2qOMV_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 1 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 3 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 14 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 15 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 7 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 1 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 1 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 5 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 15 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 8 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 1 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 8 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 3 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 1 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 3 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 4 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 5 Participants |
| rMenB+OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 12 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 3 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 1 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 2 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 8 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 13 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 2 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 7 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 6 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 1 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 2 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 3 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 0 Participants |
| Menveo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 11 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 1 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 1 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 6 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 9 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 1 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 6 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 11 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 3 Participants |
| 2B_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 11 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 4 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 3 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 10 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 7 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 5 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 18 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 6 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 2 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 17 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 18 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 8 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 1 Participants |
| 2B_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 4 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 2 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 1 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 1 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 1 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_OMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 19 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 20 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 15 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 4 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 19 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 11 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 6 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 12 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 8 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 1 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 8 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 4 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 11 Participants |
| 1M_qOMV | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 6 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 9 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 6 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 17 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 10 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 17 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 17 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 9 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 4 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 3 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 5 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 8 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 1 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 4 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 5 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 3 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 1 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 5 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 2 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 1 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| 1M_Pbo | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 0 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fever >38 °C (N=25,24,17,23,11,21,6,21,19,18,185) | 3 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Nausea(N=26,23,17,23,11,21,6,21,19,19,186) | 24 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any AEs (N=26,24,17,23,11,21,6,21,19,19,187) | 137 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Myalgia(N=26,23,17,23,10,21,6,21,19,19,185) | 31 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Loss ofAppetite(N=26,23,17,23,11,21,6,21,19,19,186 | 26 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Headache(N=26,23,17,23,11,21,6,21,19,19,186) | 53 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Fever (N=0,0,1,0,0,0,0,0,0,0,1) | 1 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Analgesic/Antipyr. Pain (N=0,0,1,0,0,0,0,0,0,0,1) | 1 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Chills(N=26,23,17,23,11,21,6,21,19,19,186) | 14 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Arthralgia(N=25,23,17,23,10,21,6,21,19,19,184) | 20 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Systemic (N=26,24,17,23,11,21,6,21,19,19,187) | 86 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Pain (N=26,24,17,23,11,21,6,21,19,19,187) | 116 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Induration (N=26,23,17,23,11,21,6,21,19,18,185) | 52 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Erythema (N=26,23,17,23,11,21,6,21,19,19,186) | 53 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Any Local (N=26,24,17,23,11,21,6,21,19,19,187) | 124 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Rash (N=26,23,17,23,11,21,6,21,18,19,185) | 5 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Fatigue(N=26,23,17,23,11,21,6,21,19,19,186) | 60 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Treatment (N=25,23,17,23,11,21,6,21,19,19,185) | 22 Participants |
| Total | 23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study. | Prevention (N=25,23,17,23,11,21,6,21,19,19,185) | 3 Participants |
Secondary
24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.
Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30. Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
Time frame: Day 1 through Day 30
Population: Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 6 Participants |
| 2OMV_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 3 Participants |
| 2qOMV_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 1 Participants |
| 2qOMV_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 4 Participants |
| rMenB+OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 3 Participants |
| rMenB+OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 5 Participants |
| Menveo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 0 Participants |
| Menveo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 2 Participants |
| 2B_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 3 Participants |
| 2B_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 2 Participants |
| 2B_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 7 Participants |
| 2B_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 3 Participants |
| 1M_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 0 Participants |
| 1M_OMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 1 Participants |
| 1M_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 6 Participants |
| 1M_qOMV | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 2 Participants |
| 1M_Pbo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 5 Participants |
| 1M_Pbo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 3 Participants |
| 1M_Pbo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | At least possibly related | 0 Participants |
| 1M_Pbo | 24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study. | Any AEs | 4 Participants |
Secondary
25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.
Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.
Time frame: Day 1 to Day 365
Population: Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 0 Participants |
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 0 Participants |
| 2OMV_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 12 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 0 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 3 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 10 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 2qOMV_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 2 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 1 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| rMenB+OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 12 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 9 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 1 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 0 Participants |
| Menveo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 0 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 0 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 6 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 2B_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 1 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 1 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 2B_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 9 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 0 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 0 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 1 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 1M_OMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 1 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 13 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 0 Participants |
| 1M_qOMV | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 1 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 1 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 11 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | NOCD | 1 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | AEs leading to withdrawal | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Medically attended AEs | 11 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | At Least Possibly related SAEs | 0 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Any SAEs | 1 Participants |
| 1M_Pbo | 25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study. | Deaths | 0 Participants |
Secondary
26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.
Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102\_03 (NCT01272180) up to Day 1 visit in V102\_03E1 study, is reported. (Any NOCD AEs: NOCD V102\_03 (NCT01272180) vs. NOCD- Day 1, V102\_03E1)
Time frame: From primary parent study completion up to Day 1 in this study.
Population: Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2OMV_OMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 2 Participants |
| 2qOMV_qOMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 4 Participants |
| rMenB+OMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 0 Participants |
| Menveo | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 1 Participants |
| 2B_OMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 0 Participants |
| 2B_qOMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 2 Participants |
| 1M_OMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 1 Participants |
| 1M_qOMV | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 2 Participants |
| 1M_Pbo | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 2 Participants |
| 1M_Pbo | 26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination. | 1 Participants |
Secondary
3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.
Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Time frame: Day 1 (Pre vaccination)
Population: Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men A (N=51,40,38,58) | 27 Percentages of Subjects |
| 2OMV_OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men C (N=48,38,38,58) | 67 Percentages of Subjects |
| 2OMV_OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men W (N=50,36,38,56) | 92 Percentages of Subjects |
| 2OMV_OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men Y (N=51,38,38,59) | 65 Percentages of Subjects |
| 2qOMV_qOMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men C (N=48,38,38,58) | 68 Percentages of Subjects |
| 2qOMV_qOMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men W (N=50,36,38,56) | 75 Percentages of Subjects |
| 2qOMV_qOMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men Y (N=51,38,38,59) | 50 Percentages of Subjects |
| 2qOMV_qOMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men A (N=51,40,38,58) | 28 Percentages of Subjects |
| rMenB+OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men W (N=50,36,38,56) | 76 Percentages of Subjects |
| rMenB+OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men C (N=48,38,38,58) | 45 Percentages of Subjects |
| rMenB+OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men Y (N=51,38,38,59) | 16 Percentages of Subjects |
| rMenB+OMV | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men A (N=51,40,38,58) | 29 Percentages of Subjects |
| Menveo | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men Y (N=51,38,38,59) | 46 Percentages of Subjects |
| Menveo | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men C (N=48,38,38,58) | 57 Percentages of Subjects |
| Menveo | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men A (N=51,40,38,58) | 31 Percentages of Subjects |
| Menveo | 3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y. | Men W (N=50,36,38,56) | 68 Percentages of Subjects |
Secondary
4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.
Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Time frame: Day 1 (Pre vaccination)
Population: Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 76 Percentages of Subjects |
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 22 Percentages of Subjects |
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 24 Percentages of Subjects |
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 37 Percentages of Subjects |
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 29 Percentages of Subjects |
| 2OMV_OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 24 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 8 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 29 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 87 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 16 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 18 Percentages of Subjects |
| 2qOMV_qOMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 13 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 34 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 35 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 50 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 16 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 26 Percentages of Subjects |
| rMenB+OMV | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 94 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 14 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 3 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 3 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 22 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 19 Percentages of Subjects |
| Menveo | 4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 7 Percentages of Subjects |
Secondary
5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Time frame: Day 1 (Pre-vaccination)
Population: Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men A (N=51,40,38,58) | 3.34 Titers |
| 2OMV_OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men C (N=48,38,38,58) | 18 Titers |
| 2OMV_OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men W (N=50,36,38,56) | 35 Titers |
| 2OMV_OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men Y (N=51,38,38,59) | 13 Titers |
| 2qOMV_qOMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men C (N=48,38,38,58) | 13 Titers |
| 2qOMV_qOMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men W (N=50,36,38,56) | 23 Titers |
| 2qOMV_qOMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men Y (N=51,38,38,59) | 8.85 Titers |
| 2qOMV_qOMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men A (N=51,40,38,58) | 3.3 Titers |
| rMenB+OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men W (N=50,36,38,56) | 20 Titers |
| rMenB+OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men C (N=48,38,38,58) | 6.05 Titers |
| rMenB+OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men Y (N=51,38,38,59) | 1.8 Titers |
| rMenB+OMV | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men A (N=51,40,38,58) | 2.96 Titers |
| Menveo | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men Y (N=51,38,38,59) | 6.49 Titers |
| Menveo | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men C (N=48,38,38,58) | 10 Titers |
| Menveo | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men A (N=51,40,38,58) | 4.14 Titers |
| Menveo | 5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y. | Men W (N=50,36,38,56) | 17 Titers |
Secondary
6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.
The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo. Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180).
Time frame: Day 1 (Pre-vaccination)
Population: Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 2.67 Titers |
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 2.54 Titers |
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 16 Titers |
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 2.67 Titers |
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 2.03 Titers |
| 2OMV_OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 3.76 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 1.78 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 2.1 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 1.46 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 33 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 2.42 Titers |
| 2qOMV_qOMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 1.94 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 3.22 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 4.56 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 2.82 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 4.72 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 39 Titers |
| rMenB+OMV | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 1.75 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | 5/99 (N=51,38,36,59) | 2.46 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M01-0240364 (N=50,37,37,58) | 1.37 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M07-0241084 (N=51,38,38,59) | 2.35 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | H44/76 (N=51,39,38,59) | 1.32 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | NZ98/254 (N=51,39,38,59) | 1.16 Titers |
| Menveo | 6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B. | M14459 (N=51,39,38,59) | 1.87 Titers |
Secondary
7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.
The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 34 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 23 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 3.41 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 259 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 660 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 10 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 464 Titers |
| 2OMV_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 792 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 15 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 17 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 2.92 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 34 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 4.28 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 33 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 16 Titers |
| 2qOMV_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 16 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 30 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 612 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 15 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 17 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 697 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 880 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 333 Titers |
| rMenB+OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 2.86 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 2.73 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 26 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 5.17 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 3.07 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 11 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 11 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 18 Titers |
| Menveo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 5.66 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 5.45 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 2.26 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 292 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 48 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 438 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 25 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 392 Titers |
| 2B_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 2.4 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 9.02 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 29 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 39 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 135 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 1.84 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 416 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 3.94 Titers |
| 2B_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 363 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 138 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 6.62 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 338 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 7.75 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 28 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 629 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 6.43 Titers |
| 1M_OMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 658 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 364 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 9.37 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 7.53 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 419 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 5.79 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 46 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 2.09 Titers |
| 1M_qOMV | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 304 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 30, N=25,25,16,23,11,21,21,18,18) | 6.36 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 1, N=25,25,16,22,11,21,19,16,18) | 5.02 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 1, N=20,23,10,22,7,16,21,18,17) | 17 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 30, N=20,24,16,22,11,19,19,17,16) | 16 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men C (Day 30, N=21,24,11,23,7,16,21,18,18) | 20 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men W (Day 1, N=20,24,13,21,11,19,18,17,15) | 9.42 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men Y (Day 1, N=25,25,14,22,11,21,21,18,18) | 5.32 Titers |
| 1M_Pbo | 7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y. | Men A (Day 30, N=25,25,16,22,11,21,19,17,18) | 4.91 Titers |
Secondary
8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.
The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 31 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 3.53 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 29 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 2.28 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 50 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 97 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 2.57 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 2.92 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 1131 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 685 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.65 Titers |
| 2OMV_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 17 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 3.11 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 2.11 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 16 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 2.18 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 2.36 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 20 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 3.54 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 2.58 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 3.66 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 2.03 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 3.21 Titers |
| 2qOMV_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 2.03 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 29 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 1.6 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 2.16 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.32 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 856 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 12 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 1598 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 20 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 2.67 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 56 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 35 Titers |
| rMenB+OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 1.46 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 2.52 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 2.33 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 2.48 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 30 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 34 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 1.92 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 2.54 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 1.36 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 1.87 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 1.94 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 2.27 Titers |
| Menveo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.58 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 2.46 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.72 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 27 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 56 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 68 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 3.45 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 1336 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 2205 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 17 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 132 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 4.10 Titers |
| 2B_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 3.11 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 43 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 28 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 79 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 3.24 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 3.18 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 2.07 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 69 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 1275 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 6.81 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 6.08 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 35 Titers |
| 2B_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 2576 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 2.08 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 2.97 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 3.26 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 3.44 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 2.48 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 1.09 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 28 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 1.34 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 5.27 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 3.5 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.18 Titers |
| 1M_OMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 1.91 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 1.45 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 1.47 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 2.06 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 2.15 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 30 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 3.85 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 1.23 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 3.42 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 1.74 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 2.57 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.18 Titers |
| 1M_qOMV | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 1.58 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 30, N=25,25,17,22,11,21,20,19,18) | 1.76 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M01-0240364 (Day 1, N=24,25,15,20,10,21,20,18,18) | 1.63 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 30, 25,25,17,23,11,21,19,19,18) | 1.63 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 30, N= 25,25,17,23,11,21,21,19,18) | 1.71 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | NZ98/254 (Day 1, N= 25,25,15,23,11,21,21,19,18) | 1.12 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 30, N=25,25,17,23,11,21,21,19,18) | 3.41 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 30, N=25,25,17,23,11,21,21,19,18) | 3.86 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M07-0241084 (Day 1, N= 25,25,15,22,11,21,21,19,18) | 3.01 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | H44/76 (Day 1, N= 25,25,16,22,11,21,19,19,18) | 1.18 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | 5/99 (Day 1, N=25,25,15,22,9,21,21,19,18) | 2.81 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 30, N=25,25,17,23,11,21,20,19,18) | 2.93 Titers |
| 1M_Pbo | 8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B. | M14459 (Day 1, N=25,25,15,23,11,21,20,19,18) | 2.37 Titers |
Secondary
9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.
Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo. Four-fold rise is defined as follows: for subjects with a pre-vaccination titer \< 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase.
Time frame: Day 1 and Day 30
Population: Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102\_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 84 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 54 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 50 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 78 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 25 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 72 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 100 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 100 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 76 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 96 Percentages of Subjects |
| 2OMV_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 76 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 4 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 4 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 100 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 46 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 48 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 17 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 4 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 74 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 0 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 96 Percentages of Subjects |
| 2qOMV_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 0 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 63 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 67 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 100 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 63 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 93 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 87 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 93 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 50 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 94 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 87 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 94 Percentages of Subjects |
| rMenB+OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 31 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 0 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 75 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 96 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 4 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 0 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 0 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 19 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 59 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 59 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 5 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 100 Percentages of Subjects |
| Menveo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 0 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 100 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 82 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 82 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 91 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 55 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 82 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 45 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 91 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 100 Percentages of Subjects |
| 2B_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 91 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 67 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 76 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 95 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 85 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 76 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 60 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 90 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 90 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 95 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 70 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 55 Percentages of Subjects |
| 2B_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 62 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 19 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 15 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 20 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 57 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 37 Percentages of Subjects |
| 1M_OMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 14 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 79 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 5 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 5 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 22 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 26 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_qOMV | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day30,N=24,25,15,20,10,21,20,18,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 30,N=25,25,15,22,11,21,21,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 1, N=24,25,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 30, N=25,25,16,22,11,21,19,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M07-0241084 (Day 1, N=24,23,16,21,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M14459 (Day 30, N=25,25,15,23,11,21,5,20,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 30, N=25,25,15,23,11,21,21,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | NZ98/254 (Day 1, N=24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | M01-0240364 (Day 1, N=23,23,16,20,11,20,6,5,4) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 30, N=25,25,15,22,9,21,21,19,18) | 6 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | H44/76 (Day 1, N=24,25,16,23,11,20,6,5,5) | 0 Percentages of Subjects |
| 1M_Pbo | 9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains. | 5/99 (Day 1, N= 24,24,16,22,11,20,6,5,5) | 0 Percentages of Subjects |