Meningococcal Infections
Conditions
Keywords
Meningococcal meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Brief summary
Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b \[DTaP-IPV-HB-Hib vaccine\]) to infants and toddlers 6 weeks to 18 months old Secondary objectives: This study aimed to demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine was given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. \- This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.
Interventions
BIOLOGICALMenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular
Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular
BIOLOGICALDTaP-IPV-HB-Hib vaccine
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine
BIOLOGICALPneumococcal vaccine (13-valent)
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
BIOLOGICALPneumococcal vaccine (10-valent)
Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)
BIOLOGICALMMR vaccine
Measles, mumps, and rubella vaccine
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
Modified double blind for Groups 1 and 2 and open label for Groups 3 and 4 for meningococcal vaccines. Open-label for all concomitant routine vaccines. Modified double-blind: the participants parent / legally acceptable representative, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccines but will not be involved in safety data collection.
Eligibility
Sex/Gender
ALL
Age
42 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged ≥ 42 to ≤ 89 days on the day of the first study visit * Healthy infants as determined by medical history, physical examination and judgment of the Investigator * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * Subject and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all study procedures * Covered by health insurance according to local regulations
Exclusion criteria
* Participated at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Received any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. This exclusion criterion did not apply to subjects in Finland, Sweden or Poland who planned to receive the licensed rotavirus vaccine concomitantly with study vaccines at study vaccination visits V1 and V2. * Received or planned to receipt during the study period 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 serogroup-containing vaccine) * Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella. Previous vaccination against hepatitis B when administered to risk groups, as per local recommendation. * Received immune globulins, blood or blood-derived products since birth * Known or suspected congenital or acquired immunodeficiency; or received immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth * Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated * Individuals that had blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * Individuals that had active tuberculosis * History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease * Individuals that were at high risk for meningococcal infection during the study (specifically, but not limited to, subjects that had persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease) * Individuals that had underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus \[HIV\] infection) * History of any neurologic disorders, including seizures and progressive neurologic disorders * History of Guillain-Barré syndrome * Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin * Reported of thrombocytopenia, contraindicating intramuscular vaccination in the investigator's opinion * Bleeding disorder, or received of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion * Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that, in the opinion of the investigator, were at a stage where it could interfere with study conduct or completion * Any condition which, in the opinion of the investigator, could interfere with the evaluation of the study objectives, including planned to leave the area of the study site before the end of the study * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject could not be included in the study until the condition was resolved or the febrile event was subsided. * Received oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * Infants born preterm (by less than 37 weeks of gestation) required specific immunization schedule for routine childhood vaccines and/or specific care at the time of vaccination, as per national recommendations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | At 30 days post Dose 3 [12 to 18 months of age (MoA)] | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. |
| Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
| Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place. |
| Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place. |
| Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA) | GMCs of anti-pertussis antibodies (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]) were measured by electrochemiluminescent (ECL) assay. |
| Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA) | GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen \[HBsAg\]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate \[PRP\]) by Farr-type radioimmunoassay (RIA). |
| Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA) | GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations \>=0.01 international units (IU)/milliliter (mL), \>=0.1 IU/mL and \>=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers \>=1:8; anti-PRP antibody concentrations \>=0.15 microgram (mcg)/mL and \>=1 mcg/mL. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | At 30 days post Dose 2 (4 MoA) | Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
| Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA) | GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations \>=10 mIU/mL and \>=100 mIU/mL. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) | GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. |
| Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA) | GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. |
| Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) | GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place. |
| Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA) | GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place. |
| Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA) | GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA) | GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: \>=255 mIU/mL; mumps: \>=10 mumps antibody units/mL and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place. |
| Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA) | GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is \<4 × lower limit of quantification (LLOQ), post-primary vaccination concentration \>=4 × LLOQ, if the pre-primary vaccination concentration is \>=4 ×LLOQ, post-primary vaccination concentration \>=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is \<4 × LLOQ, post-booster vaccination concentration \>=4 × pre-booster concentration, if the pre-booster vaccination concentration is \>=4 × LLOQ, post-booster vaccination concentration \>=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place. |
Countries
Czechia, Finland, Italy, Poland, Romania, Spain, Sweden
Participant flow
Recruitment details
This study was conducted at 33 investigational sites in 7 countries between 14 December 2018 to 24 May 2023.
Pre-assignment details
A total of 1660 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. | 714 |
| Group 2: Nimenrix Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. | 726 |
| Group 3: MenACYW Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. | 112 |
| Group 4: MenACYW Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines. | 108 |
| Total | 1,660 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 3 | 1 | 0 |
| Overall Study | Protocol deviation | 5 | 7 | 3 | 0 |
| Overall Study | Withdrawal by Parent/Guardian | 24 | 24 | 2 | 4 |
Baseline characteristics
| Characteristic | Total | Group 1: MenACYW | Group 2: Nimenrix | Group 3: MenACYW | Group 4: MenACYW |
|---|---|---|---|---|---|
| Age, Continuous | 71.2 Days STANDARD_DEVIATION 12.1 | 72.6 Days STANDARD_DEVIATION 12.2 | 72.4 Days STANDARD_DEVIATION 12.1 | 62.5 Days STANDARD_DEVIATION 7.12 | 63.3 Days STANDARD_DEVIATION 7.93 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Multiple origin | 11 Participants | 4 Participants | 6 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 30 Participants | 13 Participants | 16 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 1599 Participants | 693 Participants | 699 Participants | 106 Participants | 101 Participants |
| Sex: Female, Male Female | 836 Participants | 355 Participants | 378 Participants | 45 Participants | 58 Participants |
| Sex: Female, Male Male | 824 Participants | 359 Participants | 348 Participants | 67 Participants | 50 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 / 696 | 0 / 706 | 0 / 112 | 0 / 108 |
| other Total, other adverse events | 678 / 696 | 680 / 706 | 107 / 112 | 103 / 108 |
| serious Total, serious adverse events | 51 / 696 | 57 / 706 | 8 / 112 | 3 / 108 |
Outcome results
Primary
Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).
Time frame: At 30 days post Dose 3 [12 to 18 months of age (MoA)]
Population: Per-Protocol Analysis Set 2 (PPAS2) was a subset of Full Analysis Set 2 (FAS2). The FAS2 included the subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup A | 131 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup C | 565 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup W | 423 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y | 285 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y | 160 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup A | 189 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup W | 275 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | Serogroup C | 120 Titer |
Comparison: Statistical analysis for Serogroup A95% CI: [0.565, 0.842]
Comparison: Statistical analysis for Serogroup C95% CI: [4, 5.58]
Comparison: Statistical analysis for Serogroup W95% CI: [1.33, 1.78]
Comparison: Statistical analysis for Serogroup Y95% CI: [1.55, 2.04]
Secondary
Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies
GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA).
Time frame: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Population: PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 83.3 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 2780 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 56.8 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 86.1 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 2919 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 56.0 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 72.8 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 3457 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 105 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 4 | 3933 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 4 | 74.4 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 4 | 121 Titer |
Secondary
Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies
GMCs of anti-pertussis antibodies (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\]) were measured by electrochemiluminescent (ECL) assay.
Time frame: Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 0 before dose 1 | 2.97 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 0 before dose 1 | 10.8 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 0 before dose 1 | 10.1 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 0 before dose 1 | 2.61 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 0 before dose 1 | 11.0 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 0 before dose 1 | 55.6 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS2: Anti-PT: Day 0 before dose 4 | 10.7 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies | PPAS2: Anti-FHA: Day 0 before dose 4 | 30.3 Titer |
Secondary
Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines
GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen \[HBsAg\]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate \[PRP\]) by Farr-type radioimmunoassay (RIA).
Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 30 after dose 3 | 1595 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-diphtheria: Day 30 after dose 2 | 0.523 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 0 before dose 3 | 0.086 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 0 before dose 3 | 33.2 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-FHA: Day 30 after dose 2 | 92.4 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 30 after dose 3 | 1.82 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 0 before dose 3 | 14.5 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 0 before dose 3 | 53.0 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 30 after dose 3 | 2214 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 0 before dose 3 | 0.362 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 2: Day 30 after dose 2 | 139 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-tetanus: Day 30 after dose 2 | 1.10 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 30 after dose 3 | 6.71 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PT: Day 30 after dose 2 | 64.9 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-HBsAg: Day 30 after dose 2 | 369 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 30 after dose 3 | 9.42 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 0 before dose 3 | 14.8 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 30 after dose 3 | 1099 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 0 before dose 3 | 19.7 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 30 after dose 3 | 111 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 3: Day 30 after dose 2 | 133 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 30 after dose 3 | 2273 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 0 before dose 3 | 0.201 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 0 before dose 3 | 38.4 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PRP: Day 30 after dose 2 | 0.376 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 1: Day 30 after dose 2 | 47.1 Titer |
| Group 1: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 30 after dose 3 | 177 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 30 after dose 3 | 1.69 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 1: Day 30 after dose 2 | 43.5 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 0 before dose 3 | 48.8 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-diphtheria: Day 30 after dose 2 | 0.489 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 30 after dose 3 | 1533 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 0 before dose 3 | 13.6 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 30 after dose 3 | 994 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 30 after dose 3 | 2158 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 0 before dose 3 | 33.1 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 2: Day 30 after dose 2 | 143 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 30 after dose 3 | 2146 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 0 before dose 3 | 18.4 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 3: Day 30 after dose 2 | 145 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PT: Day 30 after dose 2 | 68.1 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PRP: Day 30 after dose 2 | 0.435 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 0 before dose 3 | 0.080 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 30 after dose 3 | 184 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-FHA: Day 30 after dose 2 | 96.6 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 30 after dose 3 | 11.5 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 0 before dose 3 | 0.424 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 30 after dose 3 | 8.59 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 0 before dose 3 | 14.6 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-HBsAg: Day 30 after dose 2 | 345 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 30 after dose 3 | 109 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-tetanus: Day 30 after dose 2 | 1.13 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 0 before dose 3 | 0.224 Titer |
| Group 2: Nimenrix | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 0 before dose 3 | 38.1 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 30 after dose 3 | 1538 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 30 after dose 3 | 1117 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-diphtheria: Day 30 after dose 2 | 0.563 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-tetanus: Day 30 after dose 2 | 0.931 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PT: Day 30 after dose 2 | 50.0 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-FHA: Day 30 after dose 2 | 125 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-HBsAg: Day 30 after dose 2 | 218 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 1: Day 30 after dose 2 | 362 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 2: Day 30 after dose 2 | 618 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-polio 3: Day 30 after dose 2 | 584 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS1: Anti-PRP: Day 30 after dose 2 | 0.725 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 0 before dose 3 | 0.094 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 30 after dose 3 | 2.71 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 0 before dose 3 | 0.218 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 30 after dose 3 | 6.02 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 0 before dose 3 | 10.4 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 30 after dose 3 | 79.2 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 0 before dose 3 | 30.6 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 30 after dose 3 | 168 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 0 before dose 3 | 26.0 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 0 before dose 3 | 55.2 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 0 before dose 3 | 85.3 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 30 after dose 3 | 3549 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 0 before dose 3 | 37.7 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 30 after dose 3 | 2431 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 0 before dose 3 | 0.244 Titer |
| Group 3: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 30 after dose 3 | 16.1 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-diphtheria: Day 30 after dose 4 | 3.26 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 3: Day 30 after dose 4 | 3397 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-FHA: Day 30 after dose 4 | 181 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PT: Day 30 after dose 4 | 80.9 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-PRP: Day 30 after dose 4 | 16.1 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 2: Day 30 after dose 4 | 3858 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-tetanus: Day 30 after dose 4 | 7.00 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-polio 1: Day 30 after dose 4 | 1625 Titer |
| Group 4: MenACYW | Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines | PPAS2: Anti-HBsAg: Day 30 after dose 4 | 1144 Titer |
Secondary
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine
GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum.
Time frame: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 1 | 1.68 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 4 | 1.97 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 5 | 1.08 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 6B | 0.600 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 7F | 2.03 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 9V | 1.67 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 14 | 5.92 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 18C | 0.680 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 19F | 1.59 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 23F | 0.830 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 1 | 4.71 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 4 | 3.61 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 5 | 2.21 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 6B | 4.21 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 7F | 2.91 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 9V | 4.08 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 14 | 9.07 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 18C | 2.12 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 19F | 9.03 Titer |
| Group 1: MenACYW | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 23F | 2.24 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 7F | 2.89 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 1 | 1.71 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 1 | 4.54 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 4 | 2.06 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 19F | 8.41 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 5 | 1.10 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 4 | 3.19 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 6B | 0.660 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 9V | 4.17 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 7F | 2.20 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 5 | 2.05 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 9V | 1.81 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 23F | 2.04 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 14 | 5.97 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 6B | 4.36 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 18C | 0.796 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 18C | 2.17 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 19F | 1.45 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS2: Serogroup 14 | 7.89 Titer |
| Group 2: Nimenrix | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine | PPAS1: Serogroup 23F | 0.869 Titer |
Secondary
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: At 30 days post Dose 2 (4 MoA)
Population: PPAS1 was a subset of FAS1. The FAS1 included the subset of randomized participants who received at least 1 dose of the study vaccine in the primary series and had a valid post-primary series vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup A | 63.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup C | 98.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup W | 96.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y | 96.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup Y | 93.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup A | 75.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup W | 94.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y | Serogroup C | 91.9 Percentage of participants |
Comparison: Statistical analysis for Serogroup A95% CI: [-17.74, -6.56]
Comparison: Statistical analysis for Serogroup C95% CI: [4.44, 9.62]
Comparison: Statistical analysis for Serogroup W95% CI: [-0.49, 4.7]
Comparison: Statistical analysis for Serogroup Y95% CI: [0.34, 5.77]
Secondary
Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine
GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.
Time frame: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 1 | 92.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 4 | 96.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 5 | 88.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 6B | 67.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 7F | 98.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 9V | 94.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 14 | 97.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 18C | 72.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 19F | 82.2 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 23F | 77.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 1 | 99.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 4 | 99.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 5 | 98.2 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 6B | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 7F | 99.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 9V | 99.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 14 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 18C | 99.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 19F | 99.3 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 23F | 98.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 18C | 98.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 1 | 93.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 1 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 4 | 96.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 9V | 99.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 5 | 90.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 4 | 99.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 6B | 69.9 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 23F | 97.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 7F | 98.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 5 | 97.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 9V | 95.1 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 14 | 99.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 14 | 98.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 6B | 99.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 18C | 77.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 19F | 99.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 19F | 79.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS2: Serogroup 7F | 99.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine | PPAS1: Serogroup 23F | 80.3 Percentage of participants |
Secondary
Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 0 before dose 1 | 11.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 0 before dose 1 | 5.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 30 post dose 2 | 77.2 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 30 post dose 2 | 63.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 0 before dose 1 | 14.3 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 0 before dose 1 | 5.2 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 30 post dose 2 | 99.0 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 30 post dose 2 | 98.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 0 before dose 1 | 31.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 0 before dose 1 | 3.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 30 post dose 2 | 98.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 30 post dose 2 | 96.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1 | 10.0 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1 | 6.4 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 30 post dose 2 | 98.3 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 30 post dose 2 | 96.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 0 before dose 3 | 69.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 0 before dose 3 | 33.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 30 post dose 3 | 98.2 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 30 post dose 3 | 94.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 0 before dose 3 | 92.5 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 0 before dose 3 | 88.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 30 post dose 3 | 99.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 30 post dose 3 | 99.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 0 before dose 3 | 96.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 0 before dose 3 | 89.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 30 post dose 3 | 99.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 0 before dose 3 | 95.8 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 0 before dose 3 | 87.9 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 0 before dose 1 | 28.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 0 before dose 3 | 73.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 0 before dose 1 | 6.4 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 0 before dose 3 | 91.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 30 post dose 2 | 88.0 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 0 before dose 3 | 46.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 30 post dose 2 | 75.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 0 before dose 3 | 85.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 0 before dose 1 | 14.9 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 30 post dose 3 | 98.1 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 0 before dose 1 | 5.2 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 0 before dose 3 | 77.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 30 post dose 2 | 96.4 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 30 post dose 3 | 96.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 30 post dose 2 | 91.9 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 0 before dose 1 | 11.0 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 0 before dose 3 | 62.1 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 0 before dose 1 | 3.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 30 post dose 2 | 98.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 0 before dose 3 | 41.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 30 post dose 2 | 94.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 0 before dose 3 | 69.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1 | 9.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 30 post dose 3 | 98.1 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1 | 5.6 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 30 post dose 3 | 99.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 30 post dose 2 | 97.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 30 post dose 3 | 95.5 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 30 post dose 2 | 93.5 Percentage of participants |
Secondary
Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup A: Day 30 post dose 2 | 46.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup C: Day 30 post dose 2 | 97.4 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup W: Day 30 post dose 2 | 92.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup Y: Day 30 post dose 2 | 87.1 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup A: Day 30 post dose 3 | 90.6 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup C: Day 30 post dose 3 | 98.7 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup W: Day 30 post dose 3 | 99.4 Percentage of participants |
| Group 1: MenACYW | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup Y: Day 30 post dose 3 | 98.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup Y: Day 30 post dose 3 | 96.9 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup A: Day 30 post dose 2 | 60.9 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup A: Day 30 post dose 3 | 91.7 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup C: Day 30 post dose 2 | 86.8 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup W: Day 30 post dose 3 | 98.4 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup W: Day 30 post dose 2 | 88.4 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup C: Day 30 post dose 3 | 91.3 Percentage of participants |
| Group 2: Nimenrix | Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup Y: Day 30 post dose 2 | 81.4 Percentage of participants |
Secondary
Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine
GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum.
Time frame: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 4: 30 days post dose 2 | 1.73 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 1: 30 days post dose 2 | 1.47 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 3: 30 days post dose 2 | 0.658 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 5: 30 days post dose 2 | 0.803 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 6A: 30 days post dose 2 | 1.65 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 6B: 30 days post dose 2 | 0.275 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 7F: 30 days post dose 2 | 3.04 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 9V: 30 days post dose 2 | 1.25 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 14: 30 days post dose 2 | 5.88 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 18C: 30 days post dose 2 | 1.65 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 19A: 30 days post dose 2 | 2.17 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 19F: 30 days post dose 2 | 5.73 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS1: Serogroup 23F: 30 days post dose 2 | 0.722 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 1: 30 days post dose 3 | 5.32 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 3: 30 days post dose 3 | 1.13 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 4: 30 days post dose 3 | 3.99 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 5: 30 days post dose 3 | 3.33 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 6A: 30 days post dose 3 | 12.9 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 6B: 30 days post dose 3 | 7.01 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 7F: 30 days post dose 3 | 5.36 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 9V: 30 days post dose 3 | 5.12 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 14: 30 days post dose 3 | 14.8 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 18C: 30 days post dose 3 | 3.18 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 19A: 30 days post dose 3 | 8.82 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 19F: 30 days post dose 3 | 12.1 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 23F: 30 days post dose 3 | 3.70 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 7F: 30 days post dose 4 | 4.92 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 1: 30 days post dose 4 | 5.47 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 19F: 30 days post dose 4 | 12.2 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 3: 30 days post dose 4 | 1.21 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 9V: 30 days post dose 4 | 5.40 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 4: 30 days post dose 4 | 3.97 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 19A: 30 days post dose 4 | 10.9 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 5: 30 days post dose 4 | 3.95 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 14: 30 days post dose 4 | 14.7 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 6A: 30 days post dose 4 | 14.3 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 23F: 30 days post dose 4 | 4.06 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 6B: 30 days post dose 4 | 9.41 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine | PPAS2: Serogroup 18C: 30 days post dose 4 | 3.48 Titer |
Secondary
Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA.
Time frame: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A: Day 0 before dose 1 | 3.00 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A: Day 30 post dose 2 | 14.8 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C: Day 0 before dose 1 | 3.91 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C: Day 30 post dose 2 | 309 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W: Day 0 before dose 1 | 2.67 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W: Day 30 post dose 2 | 102 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y: Day 0 before dose 1 | 2.85 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y: Day 30 post dose 2 | 73.4 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup A: Day 0 before dose 3 | 5.18 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup A: Day 30 post dose 3 | 104 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup C: Day 0 before dose 3 | 26.2 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup C: Day 30 post dose 3 | 819 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup W: Day 0 before dose 3 | 39.1 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup W: Day 30 post dose 3 | 1049 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup Y: Day 0 before dose 3 | 33.0 Titer |
| Group 1: MenACYW | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup Y: Day 30 post dose 3 | 589 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup Y: Day 0 before dose 4 | 85.8 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A: Day 0 before dose 1 | 2.86 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup Y: Day 30 post dose 4 | 632 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup A: Day 30 post dose 3 | 23.0 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup A: Day 0 before dose 4 | 8.13 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C: Day 0 before dose 1 | 3.88 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup A: Day 30 post dose 4 | 62.0 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup C: Day 30 post dose 3 | 481 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup W: Day 0 before dose 4 | 92.6 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W: Day 0 before dose 1 | 3.08 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup W: Day 30 post dose 4 | 1024 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup W: Day 30 post dose 3 | 196 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup C: Day 0 before dose 4 | 56.9 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y: Day 0 before dose 1 | 2.76 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS2: Serogroup C: Day 30 post dose 4 | 791 Titer |
| Group 2: Nimenrix | Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y | PPAS1: Serogroup Y: Day 30 post dose 3 | 150 Titer |
Secondary
Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine
GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.
Time frame: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 1: 30 days post dose 2 | 89.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 3: 30 days post dose 2 | 82.0 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 4: 30 days post dose 2 | 96.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 5: 30 days post dose 2 | 76.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 6A: 30 days post dose 2 | 88.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 6B: 30 days post dose 2 | 40.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 7F: 30 days post dose 2 | 97.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 9V: 30 days post dose 2 | 88.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 14: 30 days post dose 2 | 96.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 18C: 30 days post dose 2 | 91.0 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 19A:30 days post dose 2 | 93.3 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 19F: 30 days post dose 2 | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS1: Serogroup 23F: 30 days post dose 2 | 71.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 1: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 3: 30 days post dose 3 | 97.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 4: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 5: 30 days post dose 3 | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 6A: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 6B: 30 days post dose 3 | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 7F: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 9V: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 14: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 18C: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 19A: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 19F: 30 days post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 23F: 30 days post dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 7F: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 1: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 19F: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 3: 30 days post dose 4 | 92.1 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 9V: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 4: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 19A: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 5: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 14: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 6A: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 23F: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 6B: 30 days post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine | PPAS2: Serogroup 18C: 30 days post dose 4 | 100 Percentage of participants |
Secondary
Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 0 before dose 3 | 65.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 0 before dose 3 | 37.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 30 post dose 3 | 92.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 30 post dose 3 | 89.1 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 0 before dose 1 | 28.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 0 before dose 1 | 43.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 0 before dose 1 | 10.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 30 post dose 2 | 79.1 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 0 before dose 3 | 87.2 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 0 before dose 3 | 79.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 30 post dose 2 | 96.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 0 before dose 1 | 26.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 30 post dose 2 | 63.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1 | 26.6 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 0 before dose 3 | 96.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 0 before dose 3 | 92.5 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 30 post dose 2 | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1 | 12.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 30 post dose 2 | 98.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 30 post dose 2 | 99.0 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 0 before dose 3 | 94.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 0 before dose 3 | 89.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 30 post dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 30 post dose 2 | 95.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 0 before dose 1 | 14.9 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 0 before dose 1 | 33.0 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 30 post dose 2 | 99.0 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 30 post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 0 before dose 1 | 32.6 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 0 before dose 1 | 11.2 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:4: Day 30 post dose 3 | 92.0 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup A: >=1:8: Day 30 post dose 3 | 81.8 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 0 before dose 1 | 48.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 0 before dose 1 | 32.2 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:4: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup C: >=1:8: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 0 before dose 1 | 35.6 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 0 before dose 1 | 16.7 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:4: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup W: >=1:8: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 0 before dose 1 | 22.2 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 0 before dose 1 | 12.2 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:4: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS1: Serogroup Y: >=1:8: Day 30 post dose 3 | 98.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 0 before dose 4 | 80.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 0 before dose 4 | 52.8 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:4: Day 30 post dose 4 | 82.0 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup A: >=1:8: Day 30 post dose 4 | 82.0 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 0 before dose 4 | 97.8 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 0 before dose 4 | 92.1 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:4: Day 30 post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup C: >=1:8: Day 30 post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 0 before dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 0 before dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:4: Day 30 post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup W: >=1:8: Day 30 post dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 0 before dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:8: Day 0 before dose 4 | 100 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8 | PPAS2: Serogroup Y: >=1:4: Day 30 post dose 4 | 100 Percentage of participants |
Secondary
Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer \<1:8, the post-vaccination titer must be \>=1:16 and for a participant with a pre vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.
Time frame: Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1 included subset of randomized participants who received at least 1 dose of study vaccine in primary series and had a valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup A: Day 30 post dose 2 | 51.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup C: Day 30 post dose 2 | 92.5 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup W: Day 30 post dose 2 | 94.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup Y: Day 30 post dose 2 | 89.4 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup A: Day 30 post dose 3 | 77.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup C: Day 30 post dose 3 | 97.8 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup W: Day 30 post dose 3 | 97.7 Percentage of participants |
| Group 1: MenACYW | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup Y: Day 30 post dose 3 | 91.5 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup Y: Day 30 post dose 4 | 80.9 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup A: Day 30 post dose 3 | 65.5 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup A: Day 30 post dose 4 | 63.6 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup C: Day 30 post dose 3 | 96.7 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup W: Day 30 post dose 4 | 89.5 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup W: Day 30 post dose 3 | 95.6 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS2: Serogroup C: Day 30 post dose 4 | 95.3 Percentage of participants |
| Group 2: Nimenrix | Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse | PPAS1: Serogroup Y: Day 30 post dose 3 | 94.4 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL
GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations \>=10 mIU/mL and \>=100 mIU/mL. Percentages are rounded off to the tenth decimal place.
Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=10 mIU/mL: Day 30 post dose 2 | 96.4 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 3 | 93.4 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 3 | 38.7 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 3 | 81.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=100 mIU/mL: Day 30 post dose 2 | 85.7 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 3 | 98.0 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 3 | 93.5 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 3 | 79.5 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 3 | 98.6 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 3 | 35.4 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=100 mIU/mL: Day 30 post dose 2 | 81.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=10 mIU/mL: Day 30 post dose 2 | 97.8 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 3 | 94.4 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=10 mIU/mL: Day 30 post dose 2 | 92.4 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS1: Anti-HBsAg: >=100 mIU/mL: Day 30 post dose 2 | 72.8 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 3 | 65.9 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 3 | 26.4 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 3 | 80.0 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 0 before dose 4 | 64.4 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 30 after dose 4 | 83.7 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=100 mIU/mL: Day 0 before dose 4 | 27.8 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL | PPAS2: Anti-HBsAg: >=10 mIU/mL: Day 30 after dose 4 | 91.9 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies
GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: \>=255 mIU/mL; mumps: \>=10 mumps antibody units/mL and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place.
Time frame: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)
Population: PPAS2 was a subset of FAS2. FAS2 included subset of randomized participants who received at least 1 dose of the study vaccine at booster vaccination and had a valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 98.3 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 98.7 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 98.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 99.1 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 97.3 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 98.7 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 3 | 98.9 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-measles: 30 days post dose 4 | 97.8 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-rubella: 30 days post dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies | Anti-mumps: 30 days post dose 4 | 100 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies
GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is \<4 × lower limit of quantification (LLOQ), post-primary vaccination concentration \>=4 × LLOQ, if the pre-primary vaccination concentration is \>=4 ×LLOQ, post-primary vaccination concentration \>=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is \<4 × LLOQ, post-booster vaccination concentration \>=4 × pre-booster concentration, if the pre-booster vaccination concentration is \>=4 × LLOQ, post-booster vaccination concentration \>=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place.
Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-FHA: Day 30 post dose 3 | 89.1 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 30 post dose 2 | 94.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-PT: Day 30 post dose 3 | 97.0 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 30 post dose 2 | 89.6 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-PT: Day 30 post dose 3 | 97.0 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 30 post dose 2 | 97.9 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 30 post dose 2 | 91.5 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-FHA: Day 30 post dose 3 | 90.1 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-PT: Day 30 post dose 3 | 93.3 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-PT: Day 30 post dose 2 | 82.6 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-FHA: Day 30 post dose 3 | 92.2 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS1: Anti-FHA: Day 30 post dose 2 | 62.0 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-PT: Day 30 post dose 4 | 88.8 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies | PPAS2: Anti-FHA: Day 30 post dose 4 | 91.0 Percentage of participants |
Secondary
Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)
GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations \>=0.01 international units (IU)/milliliter (mL), \>=0.1 IU/mL and \>=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers \>=1:8; anti-PRP antibody concentrations \>=0.15 microgram (mcg)/mL and \>=1 mcg/mL. Percentages are rounded off to the tenth decimal place.
Time frame: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)
Population: PPAS1 was a subset of FAS1. FAS1: subset of randomized participants who received at least 1 dose of study vaccine in primary series and had valid post-primary series vaccination blood sample result. PPAS2 was a subset of FAS2. FAS2: subset of randomized participants who received at least 1 dose of study vaccine at booster vaccination and had valid post-booster vaccination blood sample result. Only participants with data collected for each specific serogroup at specified timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 0 before dose 3 | 48.2 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=1.0 IU/mL: Day 30 post dose 2 | 32.7 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 0 before dose 3 | 79.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.01 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.1 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 0 before dose 3 | 98.2 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 0 before dose 3 | 10.7 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=1 mcg/mL: Day 30 post dose 2 | 24.2 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=1.0 IU/mL: Day 30 post dose 2 | 53.3 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 0 before dose 3 | 56.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=0.15 mcg/mL: Day 30 post dose 2 | 71.8 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 1: >=1:8: Day 30 post dose 2 | 87.0 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 3 | 99.8 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 3:>=1:8: Day 30 post dose 2 | 95.9 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 2:>=1:8: Day 30 post dose 2 | 97.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 3 | 98.2 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 0 before dose 3 | 64.4 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti- tetanus: >=0.1 IU/mL: Day 0 before dose 3 | 94.1 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 0 before dose 3 | 13.9 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 0 before dose 3 | 68.6 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 0 before dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 3 | 91.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 3 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 3 | 75.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 0 before dose 3 | 1.1 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.01 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 3 | 99.6 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 3 | 99.6 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.1 IU/mL: Day 30 post dose 2 | 90.5 Percentage of participants |
| Group 1: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 3 | 99.2 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 0 before dose 3 | 14.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 0 before dose 3 | 80.9 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 0 before dose 3 | 65.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 3 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 0 before dose 3 | 60.4 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 3 | 98.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 0 before dose 3 | 14.9 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 3 | 94.9 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.01 IU/mL: Day 30 post dose 2 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.1 IU/mL: Day 30 post dose 2 | 89.6 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=1.0 IU/mL: Day 30 post dose 2 | 32.5 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.01 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.1 IU/mL: Day 30 post dose 2 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=1.0 IU/mL: Day 30 post dose 2 | 56.3 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 1: >=1:8: Day 30 post dose 2 | 83.2 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 2:>=1:8: Day 30 post dose 2 | 98.6 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 3:>=1:8: Day 30 post dose 2 | 96.1 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=0.15 mcg/mL: Day 30 post dose 2 | 74.9 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=1 mcg/mL: Day 30 post dose 2 | 27.3 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 0 before dose 3 | 98.6 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 0 before dose 3 | 41.3 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 3 | 99.8 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 0 before dose 3 | 0.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 3 | 72.4 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 0 before dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti- tetanus: >=0.1 IU/mL: Day 0 before dose 3 | 97.4 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 3 | 99.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 0 before dose 3 | 63.7 Percentage of participants |
| Group 2: Nimenrix | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 3 | 98.9 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.1 IU/mL: Day 30 post dose 2 | 94.6 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 0 before dose 3 | 47.3 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=0.01 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 3 | 96.7 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 3:>=1:8: Day 30 post dose 2 | 98.8 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=1.0 IU/mL: Day 30 post dose 2 | 44.1 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=0.15 mcg/mL: Day 30 post dose 2 | 78.1 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.1 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-PRP: >=1 mcg/mL: Day 30 post dose 2 | 39.6 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-tetanus: >=0.01 IU/mL: Day 30 post dose 2 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 0 before dose 3 | 6.5 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 0 before dose 3 | 97.8 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-diphtheria: >=1.0 IU/mL: Day 30 post dose 2 | 33.3 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 0 before dose 3 | 84.3 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 0 before dose 3 | 0 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 3 | 97.8 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 3 | 92.4 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 0 before dose 3 | 15.1 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 0 before dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 0 before dose 3 | 93.3 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti- tetanus: >=0.1 IU/mL: Day 0 before dose 3 | 83.7 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 0 before dose 3 | 60.2 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 0 before dose 3 | 95.5 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 3 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 2:>=1:8: Day 30 post dose 2 | 100 Percentage of participants |
| Group 3: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS1: Anti-polio 1: >=1:8: Day 30 post dose 2 | 98.8 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.1 IU/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=1 mcg/mL: Day 30 after dose 4 | 96.7 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=1.0 IU/mL: Day 30 after dose 4 | 98.9 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-PRP: >=0.15 mcg/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=0.01 IU/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 2: >=1:8: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.1 IU/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-diphtheria: >=1.0 IU/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-tetanus: >=0.01 IU/mL: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 1: >=1:8: Day 30 after dose 4 | 100 Percentage of participants |
| Group 4: MenACYW | Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP) | PPAS2: Anti-polio 3: >=1:8: Day 30 after dose 4 | 100 Percentage of participants |