Meningococcal Immunisation (Healthy Volunteers)
Conditions
Brief summary
Primary Objective: To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine: * In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate vaccine 3-6 years before the booster dose. * In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine (meningococcal \[Groups A, C, Y and W135\] Oligosaccharide Diphtheria CRM197 Conjugate vaccine) 3-6 years before the booster dose. Secondary Objective: To describe: * The vaccine seroresponse, seroprotection (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\]1:8), and antibody responses (geometric mean titers \[GMTs\]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 participants per group (Groups 1 and 2). * The vaccine seroresponse, seroprotection (hSBA titer \>=1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and 2). * The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \>=1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in participants who received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier. * The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \>=1:8) of meningococcal serogroups A, C, Y, and W in participants who received either a single dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or MET43 (participants randomized to MET59 Groups 1, 3 and 4). * To describe the vaccine seroresponse, seroprotection (hSBA titer \>=1:8), and antibody responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine (Groups 3 and 4), compared to those when it was given alone (Group 1).
Detailed description
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively. Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.
Interventions
Pharmaceutical form: Solution for injection Route of administration: IM
BIOLOGICALMeningococcal Group B vaccine (Trumenba®)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
BIOLOGICALMeningococcal group B vaccine (Bexsero®)
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
The laboratory personnel who performed the serology testing were blinded to the group assignment.
Intervention model description
Partially-randomized design: all participants primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while participants primed with Menveo vaccine were automatically allocated to Group 2 (not randomized).
Eligibility
Sex/Gender
ALL
Age
13 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged \>= 13 to less than (\<) 26 years on the day of inclusion. * Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only). * For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants had a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion. * Participants aged 13 to \< 18 years: assent form had been signed and dated by the participant and informed consent form (ICF) had been signed and dated by the parent or guardian. * Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: ICF had been signed and dated by the participants. * Participant aged 13 to \< 18 years: both the participant and parent or guardian were able to attend all scheduled visits and complied with all trial procedures. * Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile. * Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Visit 3 (Day 30) except for influenza vaccination, which might be received at least 2 weeks before study investigational vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43. * Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically. * At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. * Verbal report of thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Current alcohol abuse or drug addiction. * Chronic illness (e.g., Human immunodeficiency viruses, hepatitis B, hepatitis C) that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>= 100.4 degree Fahrenheit). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 | Day 30 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. |
| Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 | Day 30 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Day 6 (post-vaccination) in study MET59 | GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \>=1:8. |
| GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 | GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Day 0 (pre-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8. |
| GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Day 0 (pre-vaccination) in study MET59 | GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Day 6 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. |
| GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59 | GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Day 30 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. |
| Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8. |
| GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59 | GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8. |
| Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Day 6 (post-vaccination) in study MET59 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Study participants were enrolled from 03-September-2019 to 07-March-2020 at 30 active sites in the United States and Puerto Rico.
Pre-assignment details
A total of 570 participants who received meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine or Menveo (meningococcal Group B) vaccine either in Study MET50 (NCT02199691), or Study MET43 (NCT02842853), or outside of Sanofi Pasteur trials were enrolled in the present study (MET59).
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | 191 |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | 190 |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). | 95 |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). | 94 |
| Total | 570 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 3 | 0 | 1 |
| Overall Study | Withdrawal by parent/guardian | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: MenACYW Conjugate Vaccine | Total | Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) |
|---|---|---|---|---|---|
| Age, Continuous | 15.4 years STANDARD_DEVIATION 1.59 | 15.4 years STANDARD_DEVIATION 1.43 | 15.3 years STANDARD_DEVIATION 1.34 | 15.1 years STANDARD_DEVIATION 1.12 | 15.8 years STANDARD_DEVIATION 1.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 49 Participants | 7 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 19 Participants | 0 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 163 Participants | 497 Participants | 86 Participants | 83 Participants | 165 Participants |
| Sex: Female, Male Female | 99 Participants | 270 Participants | 45 Participants | 41 Participants | 85 Participants |
| Sex: Female, Male Male | 92 Participants | 300 Participants | 49 Participants | 54 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 186 | 0 / 184 | 0 / 93 | 0 / 92 |
| other Total, other adverse events | 129 / 186 | 116 / 184 | 83 / 93 | 88 / 92 |
| serious Total, serious adverse events | 2 / 186 | 2 / 184 | 2 / 93 | 0 / 92 |
Outcome results
Primary
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
Time frame: Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on Per-Protocol Analysis Set 2 (PPAS2) population that included participants who received 1 dose of study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 | Serogroup A | 94.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 | Serogroup C | 97.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 | Serogroup Y | 98.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 | Serogroup W | 97.7 percentage of participants |
Primary
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.
Time frame: Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 | Serogroup A | 93.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 | Serogroup C | 98.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 | Serogroup Y | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 | Serogroup W | 98.9 percentage of participants |
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 6 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 289 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 3799 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 1658 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 1928 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 708 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 161 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 800 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 919 titers |
Secondary
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination) in study MET59
Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 12.3 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 34.5 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 19.8 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 27.4 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 11.9 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 9.19 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 15.1 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 12.2 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 26.0 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 38.4 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 28.1 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 12.8 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 32.7 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 43.3 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 12.7 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 22.0 titers |
Secondary
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59
Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 0 of MET50 or MET43 | 7.28 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 30 of MET50 or MET43 | 45.2 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 0 of MET59 | 12.5 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 0 of MET50 or MET43 | 3.48 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 30 of MET50 or MET43 | 417 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 0 of MET59 | 37.5 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 0 of MET50 or MET43 | 2.36 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 30 of MET50 or MET43 | 91.0 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 0 of MET59 | 21.8 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 0 of MET50 or MET43 | 5.34 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 30 of MET50 or MET43 | 82.7 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 0 of MET59 | 28.8 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 30 of MET50 or MET43 | 45.1 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 0 of MET50 or MET43 | 5.72 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 0 of MET50 or MET43 | 2.30 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 30 of MET50 or MET43 | 32.8 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 0 of MET50 or MET43 | 5.54 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup A: Day 0 of MET59 | 11.6 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 30 of MET50 or MET43 | 36.1 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 0 of MET50 or MET43 | 2.98 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup W: Day 0 of MET59 | 14.9 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 30 of MET50 or MET43 | 49.7 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup Y: Day 0 of MET59 | 8.49 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 | Serogroup C: Day 0 of MET59 | 11.0 titers |
Secondary
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 0 | 11.7 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 30 | 502 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 0 | 36.6 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 30 | 3708 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 0 | 20.5 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 30 | 2308 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 0 | 27.0 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 30 | 2290 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 30 | 2574 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 0 | 11.5 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 0 | 8.35 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 30 | 399 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 0 | 14.8 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 0 | 10.2 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 30 | 3036 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 30 | 2533 titers |
Secondary
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 11.7 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 502 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 36.6 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 3708 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 20.5 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 2308 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 27.0 titers |
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 2290 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 2600 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 25.5 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 593 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 2702 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 28.3 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 4741 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 37.6 titers |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 12.5 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 30.0 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 42.4 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 3472 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 21.0 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 2469 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 2064 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 12.3 titers |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 667 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 39.9 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 4064 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 629 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 12.4 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 23.2 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 2363 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 29.1 titers |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 2534 titers |
Secondary
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Time frame: Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43
Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup A: Day 0 of MET50 or MET43 | 54.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup A: Day 30 of MET50 or MET43 | 94.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup C: Day 0 of MET50 or MET43 | 18.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup C: Day 30 of MET50 or MET43 | 98.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup Y: Day 0 of MET50 or MET43 | 4.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup Y: Day 30 of MET50 or MET43 | 97.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup W: Day 0 of MET50 or MET43 | 39.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup W: Day 30 of MET50 or MET43 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup W: Day 30 of MET50 or MET43 | 93.2 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup A: Day 0 of MET50 or MET43 | 35.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup Y: Day 0 of MET50 or MET43 | 3.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup A: Day 30 of MET50 or MET43 | 81.2 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup W: Day 0 of MET50 or MET43 | 40.3 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup C: Day 0 of MET50 or MET43 | 12.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup Y: Day 30 of MET50 or MET43 | 88.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 | Serogroup C: Day 30 of MET50 or MET43 | 74.2 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Time frame: Day 0 (pre-vaccination) in study MET59
Population: Analysis was performed on full analysis set which included all participants who had a valid pre-vaccination serology result. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 72.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 86.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 79.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 86.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 52.6 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 55.3 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 77.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 71.1 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 88.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 86.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 90.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 73.7 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup W | 91.4 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup C | 85.1 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup A | 73.1 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | Serogroup Y | 80.9 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer \>=1:8.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 0 | 71.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 30 | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 0 | 87.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 0 | 79.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 0 | 86.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 0 | 71.0 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 0 | 52.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A: Day 30 | 99.4 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W: Day 0 | 77.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 0 | 50.6 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C: Day 30 | 100 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. Here, 'number analyzed'=participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 71.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 99.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 87.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 79.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 86.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 89.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 98.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 91.1 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 86.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 73.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 90.9 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 86.5 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 100 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 80.9 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 100 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 71.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 100 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 0 | 86.6 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C: Day 30 | 100 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 30 | 99.4 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A: Day 0 | 72.5 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 0 | 85.4 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 30 | 100 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W: Day 0 | 91.0 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y: Day 30 | 100 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer \>=1:8.
Time frame: Day 6 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS1 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 91.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 97.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 95.6 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 97.8 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.
Time frame: Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. Here, 'number analyzed' = participants with available data for each specified category. For this outcome measure, data were planned to be collected and analyzed for individual groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, and not for group 2 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A | 94.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C | 97.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y | 98.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W | 97.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C | 97.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y | 98.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W | 98.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A | 93.3 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y | 97.8 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C | 96.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W | 96.6 percentage of participants |
| Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A | 95.5 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup W | 97.8 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup C | 97.2 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup A | 94.4 percentage of participants |
| Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 | Serogroup Y | 98.3 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.
Time frame: Day 6 (post-vaccination) in study MET59
Population: Analysis was performed on Per-Protocol Analysis Set 1 (PPAS1) population that included participants who received 1 dose of study vaccine in MET59 and had valid serology result with no relevant protocol deviations; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Groups 1 and 2. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 82.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 89.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 95.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 97.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 88.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 77.8 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 91.1 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 93.3 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8.
Time frame: Day 30 (post-vaccination) in study MET59
Population: Analysis was performed on PPAS2 population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, and 4 as pre-specified in the protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 94.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 97.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 98.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 97.7 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup W | 98.9 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup A | 93.2 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup Y | 100 percentage of participants |
| Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed) | Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 | Serogroup C | 98.9 percentage of participants |
Comparison: Serogroup A95% CI: [-3.58, 6.95]
Comparison: Serogroup C95% CI: [-5.5, 1.6]
Comparison: Serogroup Y95% CI: [-4.09, 1.14]
Comparison: Serogroup W95% CI: [-4.72, 2.07]