Healthy Volunteers (Meningococcal Infection)
Conditions
Brief summary
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age. The secondary objectives of the study are: * To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®. * To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Detailed description
Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.
Interventions
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALMeningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALMeningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALDiphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALHaemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
BIOLOGICALPneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
BIOLOGICALHepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
BIOLOGICALVaricella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias.
Eligibility
Sex/Gender
ALL
Age
6 Months to 19 Months
Healthy volunteers
Yes
Inclusion criteria
: * Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit * Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations * Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures * For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines * For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment
Exclusion criteria
* Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine) * For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine) * For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age * 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 * Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated * Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * Individuals with active tuberculosis * History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease * At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) * History of intussusception * History of any neurologic disorders, including any seizures and progressive neurologic disorders * History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine * History of Guillain-Barré syndrome * Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast * Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C \[≥ 100.4 F\]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided * 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 |
|---|---|---|
| Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was 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 from baseline for participant with pre-vaccination hSBA titer \>= 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3. |
| Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed. |
| Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. |
| Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed. |
| Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers \>= 1:8. |
| Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed. |
| Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. |
| Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed. |
| Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was conducted at 47 centers in the United States and Puerto Rico between 04 October 2018 and 23 October 2023.
Pre-assignment details
A total of 950 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Infants: Group 1 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age. | 380 |
| Infants: Group 2 Participants received 2 doses of MENVEO® 0.5 mL IM injection at 6 to 7 MoA and 12 to 13 MoA, co-administered with pediatric vaccines recommended at this age. | 370 |
| Toddlers: Group 3 Participants received 2 doses of meningococcal polysaccharide (serogroups A, C, Y and W \[MenACYW conjugate vaccine\]) 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA. | 96 |
| Toddlers: Group 4 Participants received 2 doses of Menactra® 0.5 mL IM injection at 17 to 19 MoA and 20 to 23 MoA. | 104 |
| Total | 950 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 20 | 11 | 5 | 2 |
| Overall Study | Protocol Deviation | 15 | 8 | 1 | 2 |
| Overall Study | Withdrawal by Parent/Guardian | 47 | 60 | 7 | 6 |
Baseline characteristics
| Characteristic | Infants: Group 2 | Total | Toddlers: Group 4 | Toddlers: Group 3 | Infants: Group 1 |
|---|---|---|---|---|---|
| Age, Continuous | 6.02 Units: months STANDARD_DEVIATION 0.396 | 8.51 Units: months STANDARD_DEVIATION 4.87 | 17.9 Units: months STANDARD_DEVIATION 0.673 | 17.9 Units: months STANDARD_DEVIATION 0.632 | 6.01 Units: months STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 15 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 68 Participants | 160 Participants | 11 Participants | 11 Participants | 70 Participants |
| Race/Ethnicity, Customized Mixed origin | 20 Participants | 43 Participants | 5 Participants | 4 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 4 Participants | 14 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Unknown | 7 Participants | 10 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 264 Participants | 707 Participants | 87 Participants | 79 Participants | 277 Participants |
| Sex: Female, Male Female | 172 Participants | 452 Participants | 52 Participants | 48 Participants | 180 Participants |
| Sex: Female, Male Male | 198 Participants | 498 Participants | 52 Participants | 48 Participants | 200 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 370 | 0 / 361 | 0 / 96 | 0 / 103 |
| other Total, other adverse events | 288 / 370 | 257 / 361 | 68 / 96 | 74 / 103 |
| serious Total, serious adverse events | 6 / 370 | 12 / 361 | 1 / 96 | 4 / 103 |
Outcome results
Primary
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was 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 from baseline for participant with pre-vaccination hSBA titer \>= 1:8.
Time frame: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Population: Per-protocol analysis set 2 (PPAS2) was a subset of the full analysis set 2 (FAS2). The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 89.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 99.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 98.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 99.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 92.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 82.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 97.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 97.6 percentage of participants |
Secondary
Infants Groups 1 and 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 results were expressed as geometric mean titers.
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. PPAS3 was a subset of FAS3. FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy and had a valid pre-vaccination serology result at visit 3. Only participants with data collected for each serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup A: Day 30 | 184 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup C: Day 0 | 2.57 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup C: Day 30 | 1473 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A | 8.26 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C | 167 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y | 8.36 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W | 5.51 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup A: Day 0 | 4.73 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup Y: Day 0 | 2.54 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup Y: Day 30 | 423 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup W: Day 0 | 2.23 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup W: Day 30 | 442 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup A | 20.1 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup C | 150 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup Y | 46.2 titer |
| Infants: Group 1 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup W | 46.8 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup W | 6.16 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup A: Day 30 | 119 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup Y: Day 0 | 2.37 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup A | 14.9 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup Y: Day 30 | 133 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A | 5.45 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup Y | 6.74 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C | 41.3 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup W: Day 0 | 2.31 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y | 3.79 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS3: Serogroup C | 12.7 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W | 3.82 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup W: Day 30 | 106 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup A: Day 0 | 4.64 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup C: Day 0 | 2.48 titer |
| Infants: Group 2 | Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | PPAS2, Serogroup C: Day 30 | 319 titer |
Secondary
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers \>= 1:8.
Time frame: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 95.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 100 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 95.6 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 93.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 97.5 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 98.1 percentage of participants |
Secondary
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody 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. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. PPAS3 was a subset of FAS3. FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy and had a valid pre-vaccination serology result at visit 3. Only participants with data collected for each serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 0: >=1:4 | 15.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup W: >=1:8 | 38.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 0: >=1:8 | 8.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup C: >=1:8 | 96.9 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 0: >=1:4 | 56.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup A: >=1:8 | 54.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 0: >=1:4 | 6.8 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 0: >=1:8 | 29.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 0: >=1:8 | 4.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup Y: >=1:4 | 70.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 30: >=1:4 | 97.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 30: >=1:8 | 95.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup A: >=1:4 | 87.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup A: >=1:4 | 64.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup A: >=1:8 | 77.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup C: >=1:4 | 99.0 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup Y: >=1:8 | 60.8 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup C: >=1:8 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 0: >=1:8 | 6.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup Y: >=1:4 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup C: >=1:4 | 96.9 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup Y: >=1:8 | 96.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup W: >=1:4 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup W: >=1:4 | 49.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup W: >=1:8 | 96.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup W: >=1:8 | 50.5 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup A: >=1:4 | 55.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup A: >=1:8 | 37.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup C: >=1:4 | 93.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup C: >=1:8 | 90.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup Y: >=1:4 | 43.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup Y: >=1:8 | 26.6 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup W: >=1:4 | 37.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS1, Serogroup W: >=1:8 | 28.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 0: >=1:4 | 51.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 0: >=1:8 | 24.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 30: >=1:8 | 93.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 0: >=1:4 | 12.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 0: >=1:8 | 7.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 30: >=1:4 | 99.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup C, Day 30: >=1:8 | 98.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 0: >=1:4 | 12.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 0: >=1:8 | 6.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 30: >=1:4 | 98.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup Y, Day 30: >=1:8 | 97.5 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 0: >=1:4 | 10.8 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 0: >=1:8 | 6.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 30: >=1:4 | 96.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup W, Day 30: >=1:8 | 95.6 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup A: >=1:4 | 85.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup A: >=1:8 | 73.6 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup C: >=1:4 | 77.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup C: >=1:8 | 69.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup Y: >=1:4 | 69.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup Y: >=1:8 | 54.8 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS3, Serogroup W: >=1:4 | 61.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | PPAS2, Serogroup A, Day 30: >=1:4 | 94.9 percentage of participants |
Secondary
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed.
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 analysis set. PPAS3 was a subset of FAS3. FAS3 included all randomized participants who received at least 1 dose of study vaccine in infancy and had a valid pre-vaccination serology result at visit 3. Only participants with data collected for each serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup W: >=1:128 | 4.5 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 30: >=1:128 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup A: >=1:4 | 64.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 0: >=1:4 | 15.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 0: >=1:4 | 56.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 0: >=1:128 | 0.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup Y: >=1:4 | 70.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 30: >=1:128 | 90.0 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 0: >=1:128 | 4.9 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 0: >=1:4 | 6.8 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 0: >=1:128 | 0.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup C: >=1:4 | 96.9 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 30: >=1:4 | 97.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 30: >=1:128 | 90.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup Y: >=1:128 | 5.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup A: >=1:4 | 87.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 30: >=1:128 | 68.8 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup A: >=1:128 | 18.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup A: >=1:128 | 3.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup C: >=1:4 | 99.0 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup C: >=1:128 | 69.2 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup W: >=1:4 | 49.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup Y: >=1:4 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 0: >=1:128 | 2.0 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup Y: >=1:128 | 27.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup C: >=1:128 | 67.7 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup W: >=1:4 | 98.1 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup W: >=1:128 | 33.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 30: >=1:4 | 99.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 0: >=1:4 | 10.8 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup W: >=1:128 | 3.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup A: >=1:4 | 55.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup A: >=1:128 | 3.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup C: >=1:4 | 93.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup C: >=1:128 | 32.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup Y: >=1:4 | 43.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup Y: >=1:128 | 0.8 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup W: >=1:4 | 37.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS1, Serogroup W: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 0: >=1:4 | 51.2 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 0: >=1:128 | 3.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 30: >=1:4 | 94.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup A, Day 30: >=1:128 | 62.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 0: >=1:4 | 12.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup C, Day 30: >=1:128 | 88.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 0: >=1:4 | 12.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 30: >=1:4 | 98.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup Y, Day 30: >=1:128 | 58.8 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 30: >=1:4 | 96.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS2, Serogroup W, Day 30: >=1:128 | 56.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup A: >=1:4 | 85.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup A: >=1:128 | 12.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup C: >=1:4 | 77.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup C: >=1:128 | 6.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup Y: >=1:4 | 69.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup Y: >=1:128 | 1.1 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128 | PPAS3, Serogroup W: >=1:4 | 61.3 percentage of participants |
Secondary
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody 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. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Population: PPAS1 was a subset of FAS1. FAS1 included all randomized participants who received at least 1 dose of study vaccine in infancy (\<12 MOA) and had a valid post vaccination serology result in infancy. PPAS2 was a subset of FAS2. FAS2 included all randomized participants who received at least 1 dose of study vaccine in second year of life (\>=12 MOA) and had a valid post vaccination serology result in second year of life. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup A | 30.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup C | 92.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup Y | 30.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup W | 18.5 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup A | 89.4 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup C | 99.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup Y | 98.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup W | 99.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup W | 92.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup A | 15.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup A | 82.9 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup C | 81.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup Y | 97.7 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup Y | 7.5 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS2: Serogroup C | 97.6 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | PPAS1: Serogroup W | 8.0 percentage of participants |
Secondary
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Time frame: At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Population: The PPAS1 was a subset of the FAS1. The FAS1 included all randomized participants who received at least 1 dose of the study vaccine in infancy (\< 12 MOA) and had a valid post vaccination serology result in infancy. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 18.5 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 92.3 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 30.6 percentage of participants |
| Infants: Group 1 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 30.4 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup A | 15.3 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup W | 8.0 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup Y | 7.5 percentage of participants |
| Infants: Group 2 | Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO | Serogroup C | 81.3 percentage of participants |
Secondary
Toddlers Groups 3 and 4: 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 results were expressed as geometric mean titers.
Time frame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup A: Day 0 | 4.29 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup A: Day 30 | 45.0 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup C: Day 0 | 2.10 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y: Day 0 | 2.44 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y: Day 30 | 284 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup W: Day 0 | 2.02 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup W: Day 30 | 202 titer |
| Infants: Group 1 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup C: Day 30 | 1727 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup C: Day 30 | 59.4 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup A: Day 0 | 3.43 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y: Day 30 | 45.5 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup A: Day 30 | 13.2 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup W: Day 30 | 25.0 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup C: Day 0 | 2.41 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup W: Day 0 | 2.12 titer |
| Infants: Group 2 | Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y: Day 0 | 2.44 titer |
Secondary
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody 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. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed.
Time frame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 0: >=1:8 | 28.8 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 30: >=1:4 | 93.4 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 30: >=1:8 | 88.5 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 0: >=1:4 | 3.4 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 0: >=1:8 | 1.7 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 0: >=1:4 | 11.9 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 0: >=1:8 | 8.5 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 30: >=1:8 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 0: >=1:4 | 1.7 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 0: >=1:8 | 0 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 0: >=1:4 | 54.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 30: >=1:8 | 84.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 0: >=1:4 | 33.9 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 0: >=1:8 | 18.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 0: >=1:4 | 3.4 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 30: >=1:4 | 76.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 0: >=1:8 | 8.5 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup A, Day 30: >=1:8 | 62.5 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 0: >=1:8 | 1.7 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 30: >=1:4 | 93.8 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 0: >=1:8 | 5.1 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup W, Day 30: >=1:4 | 86.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 30: >=1:4 | 98.5 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup Y, Day 30: >=1:8 | 92.3 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8 | Serogroup C, Day 30: >=1:8 | 98.5 percentage of participants |
Secondary
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed.
Time frame: Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 0: >=1:4 | 1.7 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 30: >=1:128 | 32.8 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 0: >=1:4 | 54.2 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 30: >=1:128 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 30: >=1:4 | 93.4 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 0: >=1:4 | 11.9 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 0: >=1:4 | 3.4 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 30: >=1:4 | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 30: >=1:128 | 85.2 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 30: >=1:128 | 78.7 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 30: >=1:128 | 13.8 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 30: >=1:4 | 76.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 30: >=1:128 | 14.1 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 0: >=1:128 | 1.7 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 30: >=1:4 | 98.5 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup C, Day 30: >=1:128 | 32.3 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 0: >=1:4 | 10.2 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 30: >=1:128 | 24.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 0: >=1:4 | 3.4 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 0: >=1:4 | 33.9 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup A, Day 0: >=1:128 | 3.4 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup Y, Day 30: >=1:4 | 93.8 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 0: >=1:128 | 0 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128 | Serogroup W, Day 30: >=1:4 | 86.2 percentage of participants |
Secondary
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody 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. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Time frame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup A | 72.9 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup C | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup Y | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup W | 100 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup W | 76.3 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup A | 46.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup Y | 88.1 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination | Serogroup C | 93.2 percentage of participants |
Secondary
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Time frame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Population: The PPAS2 was a subset of the FAS2. The FAS2 included all randomized participants who received at least 1 dose of the study vaccine in the second year of life (\>= 12 MOA) and had a valid post vaccination serology result in the second year of life. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup A | 72.9 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup C | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup Y | 100 percentage of participants |
| Infants: Group 1 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup W | 100 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup W | 76.3 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup A | 46.6 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup Y | 88.1 percentage of participants |
| Infants: Group 2 | Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra | Serogroup C | 93.2 percentage of participants |