Healthy Volunteers, Meningococcal Immunisation
Conditions
Brief summary
The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose.
Detailed description
The duration of each participant's participation will be approximately 5.5 years
Interventions
Liquid solution for injection Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
* Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2) * Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures * Covered by health insurance, if required by local regulations
Exclusion criteria
* 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 traveling to countries with high endemic or epidemic disease) * Personal history of Guillain-Barré syndrome (GBS) * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine * 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 * Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Participation at the time of study enrollment (or 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 Chronic illness that, in the opinion of the Investigator, is 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 ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as vaccine seroprotection. Seroprotection rate is defined as percentage of participants with hSBA titer and rSBA titer \>=1.8 who received MenACYW conjugate vaccine 5 years earlier. Antibody persistence of meningococcal serogroups A, C, W, and Y in children at 5 years (Groups 1 and 2). |
| Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers. |
| Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers. |
| Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8. |
| Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8. |
| Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8. |
| Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8. |
| Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8. |
| Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8. |
| Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8. |
| Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate. |
| Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate. |
| Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose | Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate. |
| Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate. |
| Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Within 30 minutes after vaccination | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination). |
| Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | 7 days after vaccination | All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection/administration site reaction is an AR at and around the injection/administration site. Injection/administration site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site. |
| Group 1: Number of Participants With Unsolicited AEs | Within 30 days after vaccination | An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination). Unsolicited AEs included both serious and non-serious unsolicited AEs. |
| Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8. |
| Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) | From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks | A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event. An AESI (serious or non-serious) is defined as one of scientific and medical concern specific to the Sponsor's study vaccination or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. |
Countries
Finland, Germany, Hungary, Spain
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Participant flow
Recruitment details
The study was conducted at 26 centers in 4 countries from 23 August 2022 to 06 February 2023.
Pre-assignment details
A total of 209 participants were enrolled in this study. Results has been reported as per the primary completion date of 09 March 2023. Final analysis results will be reported at a later date.
Participants by arm
| Arm | Count |
|---|---|
| MenACYW: Group 1 Participants had a blood sample before receiving a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51). | 93 |
| MenACYW: Group 2 Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51). | 116 |
| Total | 209 |
Baseline characteristics
| Characteristic | MenACYW: Group 2 | Total | MenACYW: Group 1 |
|---|---|---|---|
| Age, Continuous | 6.26 year STANDARD_DEVIATION 0.44 | 6.27 year STANDARD_DEVIATION 0.505 | 6.28 year STANDARD_DEVIATION 0.578 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 113 Participants | 206 Participants | 93 Participants |
| Sex: Female, Male Female | 60 Participants | 95 Participants | 35 Participants |
| Sex: Female, Male Male | 56 Participants | 114 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 0 |
| other Total, other adverse events | 72 / 93 | 0 / 0 |
| serious Total, serious adverse events | 3 / 93 | 0 / 0 |
Outcome results
Primary
Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.
Time frame: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
Population: The Per-Protocol Analysis Sets 1 (PPAS1) is a subset of the Full analysis set (FAS). The FAS consisted of participants who had received the study vaccine and had a valid post-vaccination serology result 5-years after priming vaccination at visit 1. Participants data whose titers meet the hSBA vaccine seroresponse criteria have been reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | Serogroup A | 93.2 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | Serogroup C | 97.7 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | Serogroup Y | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | Serogroup W | 98.9 percentage of participants |
Secondary
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as vaccine seroprotection. Seroprotection rate is defined as percentage of participants with hSBA titer and rSBA titer \>=1.8 who received MenACYW conjugate vaccine 5 years earlier. Antibody persistence of meningococcal serogroups A, C, W, and Y in children at 5 years (Groups 1 and 2).
Time frame: At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)
Population: The FAS3 consisted of participants who had a valid baseline serology results (hSBA or rSBA accordingly). Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup C | 83.7 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup C | 59.8 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup Y | 71.7 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup W | 57.6 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup Y | 62.9 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup W | 84.8 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup A | 71.7 percentage of participants |
| MenACYW: Group 1 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup A | 78.3 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup W | 58.0 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup C | 86.2 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup W | 84.5 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup Y | 66.4 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup A | 61.7 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup C | 58.6 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | rSBA titer >=1.8, Serogroup Y | 60.6 percentage of participants |
| MenACYW: Group 2 | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | hSBA titer >=1.8, Serogroup A | 74.1 percentage of participants |
Secondary
Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | Day 1 | 2.41 IU/mL |
| MenACYW: Group 1 | Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | Day 31 | 13.7 IU/mL |
Secondary
Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and hSBA and rSBA PPAS1 individually consisted of participants for Group 1 visit 1. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: hSBA, Serogroup A | 17.2 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: hSBA, Serogroup A | 1143 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: hSBA, Serogroup W | 29.3 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: hSBA, Serogroup W | 8656 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: rSBA, Serogroup Y | 64.5 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: rSBA, Serogroup Y | 7814 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: rSBA, Serogroup W | 49.7 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: rSBA, Serogroup W | 23354 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: hSBA, Serogroup C | 36.9 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: hSBA, Serogroup C | 8933 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: hSBA, Serogroup Y | 14.6 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: hSBA, Serogroup Y | 3727 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: rSBA, Serogroup A | 150 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: rSBA, Serogroup A | 8454 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 1: rSBA, Serogroup C | 31.5 titer |
| MenACYW: Group 1 | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Day 31: rSBA, Serogroup C | 20427 titer |
Secondary
Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination).
Time frame: Within 30 minutes after vaccination
Population: The Safety analysis set 1 (SafAS 1) consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenACYW: Group 1 | Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
Secondary
Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)
A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event. An AESI (serious or non-serious) is defined as one of scientific and medical concern specific to the Sponsor's study vaccination or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate.
Time frame: From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks
Population: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) | AESI | 0 Participants |
| MenACYW: Group 1 | Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) | SAE | 3 Participants |
Secondary
Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection/administration site reaction is an AR at and around the injection/administration site. Injection/administration site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.
Time frame: 7 days after vaccination
Population: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reactions | 67 Participants |
| MenACYW: Group 1 | Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reactions | 45 Participants |
Secondary
Group 1: Number of Participants With Unsolicited AEs
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination). Unsolicited AEs included both serious and non-serious unsolicited AEs.
Time frame: Within 30 days after vaccination
Population: The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenACYW: Group 1 | Group 1: Number of Participants With Unsolicited AEs | 28 Participants |
Secondary
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | Day 1: >= 0.01 IU/mL | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | Day 31: >= 0.01 IU/mL | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | Day 1: >= 0.1 IU/mL | 95.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | Day 31: >= 0.1 IU/mL | 100 percentage of participants |
Secondary
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:4 titer, Serogroup A | 93.2 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:4 titer, Serogroup C | 97.7 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:8 titer, Serogroup C | 84.1 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:8 titer, Serogroup C | 97.7 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:8 titer, Serogroup Y | 73.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:8 titer, Serogroup Y | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:4 titer, Serogroup W | 95.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:4 titer, Serogroup W | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:8 titer, Serogroup W | 85.2 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:8 titer, Serogroup W | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:4 titer, Serogroup A | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:8 titer, Serogroup A | 78.4 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:8 titer, Serogroup A | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:4 titer, Serogroup C | 86.4 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 1: hSBA >=1:4 titer, Serogroup Y | 78.4 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | Day 31: hSBA >=1:4 titer, Serogroup Y | 100 percentage of participants |
Secondary
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup A | 93.2 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup C | 97.7 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup Y | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup W | 98.9 percentage of participants |
Secondary
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:8 titer, Serogroup A | 72.7 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:8 titer, Serogroup A | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:128 titer, Serogroup A | 64.8 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:128 titer, Serogroup A | 100 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:8 titer, Serogroup C | 62.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:8 titer, Serogroup C | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:128 titer, Serogroup C | 37.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:128 titer, Serogroup C | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:8 titer, Serogroup Y | 63.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:8 titer, Serogroup W | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:128 titer, Serogroup W | 50.0 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:128 titer, Serogroup W | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:8 titer, Serogroup Y | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:128 titer, Serogroup Y | 56.5 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 31: rSBA >=1:128 titer, Serogroup Y | 98.9 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | Day 1: rSBA >=1:8 titer, Serogroup W | 58.0 percentage of participants |
Secondary
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Time frame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
Population: The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup A | 89.8 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup C | 96.6 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup Y | 91.8 percentage of participants |
| MenACYW: Group 1 | Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup W | 97.7 percentage of participants |
Secondary
Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer \>= 1:8.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
Secondary
Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer \>= 1:32 for participants with pre-vaccination rSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer \>= 1:8.
Time frame: From Baseline (Day 1) until end of the study (approximately 5.5 years)