Healthy Volunteers (Meningococcal Infection)
Conditions
Keywords
Meningococcal meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Brief summary
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
Detailed description
The duration of each subject's participation in the trial was approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which included a safety follow up contact at 6 months after the last vaccinations.
Interventions
BIOLOGICALMenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
BIOLOGICALMenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
BIOLOGICALDTaP-IPV//Hib vaccine
DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular
BIOLOGICALPneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
BIOLOGICALPentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
BIOLOGICALHepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
BIOLOGICALMeasles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
BIOLOGICALVaricella vaccine
Varicella vaccine at 12 months of age
BIOLOGICALHepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study was conducted modified double blind for the infant part of the study, with everyone involved in the study (participants/parents, investigators, safety outcome assessor, Sponsor) blinded to the meningococcal vaccine received, except the personnel administering the vaccine.
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 guardian, and an independent witness, if required by local regulations * Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures. * Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit
Exclusion criteria
* Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine). * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease * Receipt of more than 1 previous dose of hepatitis B vaccine * Receipt of immune globulins, blood, or blood-derived products since birth * Known or suspected congenital or acquired immunodeficiency; or receipt of 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, until the immune competence of the potential vaccine recipient is demonstrated * Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems * Individuals with active tuberculosis * History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease * At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) * History of intussusception * History of any neurologic disorders, including any seizures and progressive neurologic disorders * History of Guillain-Barré syndrome * Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast * Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Chronic illness (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, was at a stage where it might have interfered with trial conduct or completion * Any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]). A prospective participant was not included in the study until the condition has been resolved or the febrile event has been subsided * Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study * The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 were assessed. |
| Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations \>=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA. |
| Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-pertussis antibodies (pertussis toxoid \[PT\], filamentous hemagglutinin adhesin \[FHA\], pertactin \[PRN\] and fimbriae types 2 and 3 \[FIM\]) were measured by electrochemiluminescent (ECL) assay. |
| Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is 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 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Vaccine response against anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay and anti-mumps antibodies were assessed by ELISA. Percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion are reported: measles: \>=255 mIU/mL; mumps: \>=10 antibody units per milliliter and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer \>=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place. |
| Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which is 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 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Anti-PRP concentrations were measured using a farr-type RIA. The percentage of participants with an PRP antibody titers \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place. |
| Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 are assessed. |
| Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Vaccine response was defined as: if the pre-booster (4th) vaccination concentration was \<lower limit of quantification (LLOQ), then the post-booster (4th) vaccination concentration should be \>=4 times LLOQ. The LLOQ was equal to 2.00 EU/mL. Percentages are rounded off to the tenth decimal place. |
| Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) | GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. PPAS2 included participants of FAS2 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[at Visit 1 to 3, \< 12 months of age\] and had a valid pre-vaccination serology result at Visit 5 before the 12-month vaccinations for Subgroups 1a and 2a or at Visit 6 before the 15-month vaccinations for Subgroups 1b and 2b) with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. |
| Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) | Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. PPAS2 included participants of FAS2 with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. Percentages are rounded off to the tenth decimal place. |
| Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Vaccine response against anti-varicella antibodies were measured by glycoprotein (gp) ELISA. Percentage of participants with anti-varicella antibody concentration \>=5 antibody (Ab) gpELISA units/mL are reported. Percentages are rounded off to the tenth decimal place. |
| Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer \>=0.15 mcg/mL and \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was conducted at 69 investigational sites in Puerto Rico and the United States. Healthy infants aged \>=42 to \<=89 days were randomized in 2:1 ratio to either Group 1: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine) and routine pediatric vaccines or Group 2: Meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria cross reacting material (CRM) 197 conjugate vaccine (MENVEO®) and routine pediatric vaccines.
Pre-assignment details
Each group was further divided into 2 subgroups based on the time of analyses conducted in the 2nd year of life (30 days after the 12-month vaccinations \[Groups 1a and 2a\] or 30 days after the 15-month vaccinations \[Groups 1b and 2b\], respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. A total of 2627 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Participants received MenACYW conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 to 15/15 to 18 months of age along with Pentacel (diphtheria-tetanus-acellular pertussis \[DTaP-IPV/Hib\] vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (pneumococcal 13-valent conjugate vaccine \[PCV13\] at 2, 4, 6, and 12 to 15 months of age; RotaTeq (pentavalent rotavirus vaccine \[RV5\]) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 to 15 months of age. Additionally, participants received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age as a part of the study.
Group 1 was divided as Groups 1a and 1b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. | 1,746 |
| Group 2: MENVEO Participants received MENVEO conjugate vaccine 0.5 mL as an IM injection at 2, 4, 6, and 12 months of age along with Pentacel (DTaP-IPV/Hib vaccine) at 2, 4, 6 and 15 to 18 months of age; PREVNAR 13 (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B (hepatitis B vaccine) at 2 and 6 months of age; M-M-R II (measles, mumps, and rubella vaccine) and VARIVAX (varicella vaccine) at 12 months of age. In addition, they also received first dose of HAVRIX (hepatitis A vaccine) at 15 to 18 months of age.
Group 2 was further divided as Groups 2a and 2b based on the time of analyses, i.e. 30 days after 12 months and 30 days after 15 months respectively. The division of the subgroups did not determine when participants received their vaccinations in the 2nd year of life. | 881 |
| Total | 2,627 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 86 | 60 |
| Overall Study | Protocol Violation | 65 | 48 |
| Overall Study | Withdrawal by parent/guardian | 263 | 149 |
Baseline characteristics
| Characteristic | Group 2: MENVEO | Total | Group 1: MenACYW Conjugate Vaccine |
|---|---|---|---|
| Age, Continuous | 65.3 days STANDARD_DEVIATION 7.81 | 65.3 days STANDARD_DEVIATION 7.95 | 65.3 days STANDARD_DEVIATION 8.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 14 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 25 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 99 Participants | 303 Participants | 204 Participants |
| Race (NIH/OMB) More than one race | 30 Participants | 74 Participants | 44 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 48 Participants | 37 Participants |
| Race (NIH/OMB) White | 722 Participants | 2150 Participants | 1428 Participants |
| Sex: Female, Male Female | 415 Participants | 1243 Participants | 828 Participants |
| Sex: Female, Male Male | 466 Participants | 1384 Participants | 918 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,727 | 0 / 867 |
| other Total, other adverse events | 1,471 / 1,727 | 746 / 867 |
| serious Total, serious adverse events | 99 / 1,727 | 38 / 867 |
Outcome results
Primary
Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 12-month vaccination (Month 13)
Population: Per-Protocol Analysis Set 3 (PPAS3) (for 2nd year of life vaccination). PPAS3 included participants of Full Analysis set 3 (FAS3: a subset of all randomized participants who received \>=1 dose of the study vaccine in the 2nd year of life \[\>=12 months of age\] and had a valid post-vaccination serology result in the 2nd year of life) with no relevant protocol deviations. Only those participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup A | 79.4 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup Y | 96.4 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup C | 97.0 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup W | 97.6 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup W | 96.4 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup A | 77.6 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup C | 88.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Serogroup Y | 92.3 percentage of participants |
Comparison: Statistical analysis for Serogroup A95% CI: [-4.38, 8.64]
Comparison: Statistical analysis for Serogroup C95% CI: [4.8, 13.6]
Comparison: Statistical analysis for Serogroup Y95% CI: [0.68, 8.44]
Comparison: Statistical analysis for Serogroup W95% CI: [-1.18, 4.45]
Primary
Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: PPAS1 (for infant vaccination). PPAS1 included participants of FAS1 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[\<12 months of age\] and had a valid post-vaccination serology result in infancy) with no relevant protocol deviations during infancy. Only those participants with data collected for each specific serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup A | 77.9 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup C | 99.0 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup Y | 98.3 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup W | 98.6 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup W | 92.9 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup A | 67.7 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup Y | 91.7 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Serogroup C | 91.2 percentage of participants |
Comparison: Statistical analysis for Serogroup A95% CI: [4.98, 15.59]
Comparison: Statistical analysis for Serogroup C95% CI: [5.31, 10.96]
Comparison: Statistical analysis for Serogroup Y95% CI: [4.01, 9.62]
Comparison: Statistical analysis for Serogroup W95% CI: [3.44, 8.57]
Secondary
Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination
GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. PPAS2 included participants of FAS2 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[at Visit 1 to 3, \< 12 months of age\] and had a valid pre-vaccination serology result at Visit 5 before the 12-month vaccinations for Subgroups 1a and 2a or at Visit 6 before the 15-month vaccinations for Subgroups 1b and 2b) with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn.
Time frame: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)
Population: Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination and 4th dose is 12-month vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: Day 30 post 3rd dose | 24.9 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: Day 30 post 3rd dose | 83.0 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: Day 30 post 3rd dose | 365 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: Day 0 before 4th dose | 42.9 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: Day 0 before 4th dose | 9.33 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: Day 30 post 3rd dose | 92.8 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: Day 0 before 4th dose | 57.8 titer |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: Day 0 before 4th dose | 57.8 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: Day 0 before 4th dose | 4.82 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: Day 0 before 4th dose | 9.27 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: Day 0 before 4th dose | 6.43 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: Day 30 post 3rd dose | 51.4 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: Day 30 post 3rd dose | 16.3 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: Day 30 post 3rd dose | 42.9 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: Day 0 before 4th dose | 10.4 titer |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: Day 30 post 3rd dose | 51.4 titer |
Secondary
Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination
GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which is 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: Day 30 post 12-month vaccination (Month 13)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified serotype are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 7F | 5.40 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 4 | 2.08 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 9V | 3.53 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 14 | 7.80 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 5 | 2.70 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 18C | 2.60 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 6A | 9.65 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 19A | 6.19 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 3 | 0.771 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 19F | 6.49 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 6B | 7.41 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 23F | 3.88 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 1 | 3.81 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 23F | 3.41 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 1 | 3.44 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 3 | 0.751 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 4 | 2.00 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 6A | 9.51 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 6B | 6.37 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 7F | 6.04 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 9V | 3.62 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 14 | 9.20 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 18C | 2.92 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 19A | 5.86 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 19F | 6.01 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Serotype 5 | 2.46 mcg/mL |
Secondary
Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. PPAS2 included participants of FAS2 with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)
Population: Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination, 4th dose is 12-month vaccination. D0 is Day 0 and D30 is Day 30.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: D30 post 3rd dose:>=1:4 | 87.0 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: D30 post 3rd dose:>=1:8 | 77.3 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A:D0 before 4th dose:>=1:4 | 82.5 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A:D0 before 4th dose:>=1:8 | 59.0 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: D30 post 3rd dose:>=1:4 (n=) | 99.3 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: D30 post 3rd dose:>=1:8 | 99.1 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C:D0 before 4th dose:>=1:4 | 95.4 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C:D0 before 4th dose:>=1:8 | 92.9 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: D30 post 3rd dose:>=1:4 | 99.1 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: D30 post 3rd dose:>=1:8 | 98.6 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y:D0 before 4th dose:>=1:4 | 99.2 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y:D0 before 4th dose:>=1:8 | 96.8 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: D30 post 3rd dose:>=1:4 | 99.8 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: D30 post 3rd dose:>=1:8 | 98.8 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W:D0 before 4th dose:>=1:4 | 98.9 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W:D0 before 4th dose:>=1:8 | 97.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W:D0 before 4th dose:>=1:8 | 62.0 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: D30 post 3rd dose:>=1:4 | 84.9 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: D30 post 3rd dose:>=1:4 | 96.3 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A: D30 post 3rd dose:>=1:8 | 70.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: D30 post 3rd dose:>=1:4 | 97.5 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A:D0 before 4th dose:>=1:4 | 66.4 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y: D30 post 3rd dose:>=1:8 | 92.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup A:D0 before 4th dose:>=1:8 | 47.0 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W:D0 before 4th dose:>=1:4 | 82.7 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: D30 post 3rd dose:>=1:4 (n=) | 93.7 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y:D0 before 4th dose:>=1:4 | 83.5 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C: D30 post 3rd dose:>=1:8 | 91.0 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup W: D30 post 3rd dose:>=1:8 | 94.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C:D0 before 4th dose:>=1:4 | 49.1 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup Y:D0 before 4th dose:>=1:8 | 69.1 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Serogroup C:D0 before 4th dose:>=1:8 | 34.0 percentage of participants |
Secondary
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination
Vaccine response against anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay and anti-mumps antibodies were assessed by ELISA. Percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion are reported: measles: \>=255 mIU/mL; mumps: \>=10 antibody units per milliliter and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 12-month vaccination (Month 13)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-measles | 97.6 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-mumps | 95.5 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-rubella | 97.9 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-measles | 97.3 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-mumps | 97.7 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Anti-rubella | 98.0 percentage of participants |
Secondary
Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination
Vaccine response against anti-varicella antibodies were measured by glycoprotein (gp) ELISA. Percentage of participants with anti-varicella antibody concentration \>=5 antibody (Ab) gpELISA units/mL are reported. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 12-month vaccination (Month 13)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination | 96.4 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination | 94.7 percentage of participants |
Secondary
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination
GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | 272 Units/mL | 95% Confidence Interval 244 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | 308 Units/mL | 95% Confidence Interval 264 |
Secondary
Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination
GMCs of anti-pertussis antibodies (pertussis toxoid \[PT\], filamentous hemagglutinin adhesin \[FHA\], pertactin \[PRN\] and fimbriae types 2 and 3 \[FIM\]) were measured by electrochemiluminescent (ECL) assay.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-PT | 75.8 ELISA units/mL | 95% Confidence Interval 72.2 |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-PRN | 39.4 ELISA units/mL | 95% Confidence Interval 36.8 |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-FHA | 95.7 ELISA units/mL | 95% Confidence Interval 90.9 |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-FIM | 309 ELISA units/mL | 95% Confidence Interval 291 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-FHA | 98.6 ELISA units/mL | 95% Confidence Interval 91.7 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-PT | 78.6 ELISA units/mL | 95% Confidence Interval 72.8 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-FIM | 311 ELISA units/mL | 95% Confidence Interval 284 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Anti-PRN | 42.1 ELISA units/mL | 95% Confidence Interval 37.9 |
Secondary
Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination
GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is 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: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified serotype are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 4 | 1.46 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 9V | 1.88 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 6A | 4.01 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 14 | 6.95 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 3 | 0.607 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 18C | 1.95 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 6B | 2.47 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 19A | 2.21 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 5 | 1.54 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 19F | 3.36 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 7F | 3.48 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 23F | 1.59 mcg/mL |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 1 | 2.26 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 23F | 1.30 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 1 | 1.93 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 3 | 0.544 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 4 | 1.33 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 5 | 1.26 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 6A | 3.34 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 6B | 1.97 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 7F | 3.40 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 9V | 1.61 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 14 | 7.17 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 18C | 1.82 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 19A | 2.00 mcg/mL |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Serotype 19F | 2.98 mcg/mL |
Secondary
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination
Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer \>=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | 98.6 percentage of participants | 95% Confidence Interval 97.4 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | 98.0 percentage of participants | 95% Confidence Interval 95.9 |
Secondary
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination
Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 were assessed.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 2 | 100 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 1 | 100 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 3 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 1 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 2 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Anti-polio 3 | 100 percentage of participants |
Secondary
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination
Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer \>=0.15 mcg/mL and \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | >=0.15 mcg/mL | 99.0 percentage of participants | 95% Confidence Interval 98.1 |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | >=1.0 mcg/mL | 91.3 percentage of participants | 95% Confidence Interval 89.2 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | >=0.15 mcg/mL | 96.4 percentage of participants | 95% Confidence Interval 94.2 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | >=1.0 mcg/mL | 85.7 percentage of participants | 95% Confidence Interval 82 |
Secondary
Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination
Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations \>=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 6-month vaccination (Month 7)
Population: Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | 91.0 percentage of participants | 95% Confidence Interval 88.5 |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | 92.8 percentage of participants | 95% Confidence Interval 89.4 |
Secondary
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination
Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 are assessed.
Time frame: Day 30 post 15-month vaccination (Month 16)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 1 | 100 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 2 | 100 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 3 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 1 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 2 | 100 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Anti-polio 3 | 100 percentage of participants |
Secondary
Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination
Anti-PRP concentrations were measured using a farr-type RIA. The percentage of participants with an PRP antibody titers \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 15-month vaccination (Month 16)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination | 98.3 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination | 98.4 percentage of participants |
Secondary
Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination
Vaccine response was defined as: if the pre-booster (4th) vaccination concentration was \<lower limit of quantification (LLOQ), then the post-booster (4th) vaccination concentration should be \>=4 times LLOQ. The LLOQ was equal to 2.00 EU/mL. Percentages are rounded off to the tenth decimal place.
Time frame: Day 30 post 15-month vaccination (Month 16)
Population: Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-PT | 98.5 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-FHA | 96.7 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-PRN | 96.3 percentage of participants |
| Group 1a:MenACYW Conjugate Vaccine (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-FIM | 98.2 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-FIM | 97.5 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-PT | 98.3 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-PRN | 97.5 percentage of participants |
| Group 2a: MENVEO (Post 12-month Vaccination) | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Anti-FHA | 96.7 percentage of participants |