Meningococcal Immunisation (Healthy Volunteers)
Conditions
Brief summary
Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®. Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Detailed description
The duration of each participant's participation in the study was approximately 30 to 44 days.
Interventions
Pharmaceutical form: Liquid solution Route of administration: IM
BIOLOGICALMeningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Liquid solution Route of administration: IM
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 to 55 years on the day of inclusion. * Informed consent form had been signed and dated by the participants or participants' parents/legally acceptable representatives as applicable. In addition: Participants 7 to 19 years provided written assent. * Participants (and participants' parents/legally acceptable representatives for the 2 to 19 years age groups) were able to attend all scheduled visits and complied with all study procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception\* or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination). \*Effective methods of contraception included oral contraception (pill), intrauterine device, or condoms used with spermicide. * Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine). * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * 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 study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling 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 study or to a vaccine containing any of the same substances. * Laboratory confirmed / self-reported thrombocytopenia, contraindicating IM vaccination in the Investigator's judgment * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's judgement. * History of Guillain-Barre syndrome. * History of convulsions. * History of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine and a diphtheria toxoid-containing vaccine within 10 years of the proposed study vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to (\>=) 99.5 degree Fahrenheit or \>= 37.5 degree Celsius). 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 For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Day 30 (post-vaccination) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Day 0 (pre-vaccination); Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers \>=1:4 and \>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure. |
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Day 0 (pre-vaccination); Day 30 (post-vaccination) | 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 hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers \<1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported. |
| Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | From Baseline (Day 0) to Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. |
| Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Day 30 (post-vaccination) | 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. |
| Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Within 7 days post-vaccination | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia. |
| Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Up to 30 days post-vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | From Day 0 up to 30 days post-vaccination | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. |
| Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Within 30 minutes post-vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB. |
Countries
Japan
Participant flow
Recruitment details
Study participants were enrolled at 4 active centers in Japan from 22 May 2020 to 05 October 2020.
Pre-assignment details
A total of 360 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0. | 180 |
| Group 2: Menactra® Vaccine Participants received a single IM dose of Menactra® vaccine on Day 0. | 180 |
| Total | 360 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: Menactra® Vaccine | Total | Group 1: MenACYW Conjugate Vaccine |
|---|---|---|---|
| Age, Continuous | 24.1 years STANDARD_DEVIATION 10.27 | 24.6 years STANDARD_DEVIATION 10.69 | 25.1 years STANDARD_DEVIATION 11.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 180 Participants | 360 Participants | 180 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 95 Participants | 179 Participants | 84 Participants |
| Sex: Female, Male Male | 85 Participants | 181 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 179 | 0 / 180 |
| other Total, other adverse events | 98 / 179 | 83 / 180 |
| serious Total, serious adverse events | 0 / 179 | 0 / 180 |
Outcome results
Primary
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
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.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) population that included participants who received 1 dose of the study vaccine and had a valid post-vaccination blood sample result with no relevant protocol deviations. 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 Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup A | 85.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup C | 96.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup Y | 97.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup W | 87.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup W | 49.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup A | 65.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup Y | 63.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis | Serogroup C | 62.6 percentage of participants |
Comparison: Serogroup A95% CI: [11.38, 28.75]
Comparison: Serogroup C95% CI: [26.2, 41.5]
Comparison: Serogroup Y95% CI: [26.66, 41.64]
Comparison: Serogroup W95% CI: [28.93, 46.53]
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
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); Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. Here, 'number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: Day 0 | 5.79 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: Day 30 | 123 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: Day 0 | 4.47 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: Day 30 | 544 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: Day 0 | 3.95 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: Day 30 | 221 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: Day 0 | 7.39 titers |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: Day 30 | 125 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: Day 30 | 36.5 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: Day 0 | 5.96 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: Day 0 | 4.29 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: Day 30 | 41.3 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: Day 0 | 8.41 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: Day 0 | 5.27 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: Day 30 | 41.5 titers |
| Group 2: Menactra® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: Day 30 | 36.6 titers |
Secondary
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 30 minutes post-vaccination
Population: Analysis was performed on Safety Analysis Set which included participants who received at least one dose of the study vaccine and had any safety data available; analyzed according to the vaccine they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 0 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 0 Participants |
Secondary
Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Time frame: From Day 0 up to 30 days post-vaccination
Population: Analysis was performed on Safety Analysis Set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 0 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 0 Participants |
Secondary
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia.
Time frame: Within 7 days post-vaccination
Population: Analysis was performed on Safety Analysis Set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site pain | 72 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site erythema | 16 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site swelling | 14 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site induration | 6 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Fever | 3 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Headache | 34 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Malaise | 22 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Myalgia | 38 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Myalgia | 30 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site pain | 66 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Fever | 1 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site erythema | 8 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Malaise | 9 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site swelling | 6 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Headache | 17 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Injection site induration | 5 Participants |
Secondary
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time frame: Up to 30 days post-vaccination
Population: Analysis was performed on Safety Analysis Set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 15 Participants |
| Group 2: Menactra® Vaccine | Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | 11 Participants |
Secondary
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: From Baseline (Day 0) to Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. 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 >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A | 85.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C | 96.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y | 97.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W | 87.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W | 49.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A | 65.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y | 63.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C | 62.6 percentage of participants |
Secondary
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers \>=1:4 and \>=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Time frame: Day 0 (pre-vaccination); Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. 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 hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:4: Day 0 | 82.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:8: Day 0 | 42.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:4: Day 30 | 98.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:8: Day 30 | 96.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:4: Day 0 | 55.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:8: Day 0 | 31.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:4: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:8: Day 30 | 98.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:4: Day 0 | 39.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:8: Day 0 | 27.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:4: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:8: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:4: Day 0 | 73.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:8: Day 0 | 51.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:4: Day 30 | 100 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:8: Day 30 | 99.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:8: Day 30 | 91.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:4: Day 0 | 82.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:4: Day 0 | 44.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:8: Day 0 | 46.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:4: Day 0 | 76.0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:4: Day 30 | 98.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:8: Day 0 | 29.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: >= 1:8: Day 30 | 92.7 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:4: Day 30 | 96.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:4: Day 0 | 65.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:4: Day 30 | 97.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:8: Day 0 | 38.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W: >= 1:8: Day 0 | 58.7 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:4: Day 30 | 90.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: >= 1:8: Day 30 | 89.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: >= 1:8: Day 30 | 81.0 percentage of participants |
Secondary
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers \<1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:256 | 20.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:16 | 2.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:512 | 14.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:2048 | 8.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:1024 | 12.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C:<1:4 | 0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:2048 | 4.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:4096 | 7.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:4096 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:32 | 3.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:8192 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:8192 | 1.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:<1:4 | 0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:1024 | 7.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:4 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:16384 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:8 | 1.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:64 | 4.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:16 | 5.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:32768 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:32 | 13.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:4 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:64 | 16.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:<1:4 | 0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:128 | 25.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:128 | 7.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:256 | 19.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:1:4 | 0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:512 | 10.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:4096 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:1024 | 6.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:1:8 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:2048 | 1.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:256 | 12.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:4096 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:16 | 1.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A:<1:4 | 1.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:8 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:4 | 1.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:32 | 6.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:8 | 2.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:512 | 22.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:16 | 4.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:64 | 16.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:32 | 11.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:2048 | 0.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:64 | 13.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:128 | 20.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:128 | 24.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:1024 | 25.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:256 | 16.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:512 | 15.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:256 | 8.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:512 | 2.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:1024 | 3.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:2048 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:4096 | 0.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C:<1:4 | 9.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:4 | 9.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:8 | 8.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:16 | 10.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:32 | 15.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:64 | 14.0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:128 | 14.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:256 | 8.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:512 | 5.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:1024 | 3.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:2048 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:4096 | 0.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:8192 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:16384 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C: 1:32768 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:<1:4 | 2.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:1:4 | 7.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y:1:8 | 11.7 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:16 | 15.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:32 | 16.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:64 | 19.0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:128 | 7.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:256 | 6.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:512 | 8.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:1024 | 2.8 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:2048 | 1.7 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:4096 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y: 1:8192 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:<1:4 | 3.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:4 | 5.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:8 | 10.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:16 | 19.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:32 | 24.6 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:64 | 14.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:128 | 9.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:256 | 3.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:512 | 2.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:1024 | 7.3 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:2048 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W:1:4096 | 0 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A:<1:4 | 1.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:4 | 6.1 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:8 | 12.3 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:16 | 18.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:32 | 17.9 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:64 | 14.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A: 1:128 | 13.4 percentage of participants |
Secondary
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
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)
Population: Analysis was performed on PPAS population. 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 Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A | 85.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C | 96.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y | 97.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W | 87.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup W | 49.2 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup A | 65.4 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup Y | 63.5 percentage of participants |
| Group 2: Menactra® Vaccine | Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine | Serogroup C | 62.6 percentage of participants |