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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1183-6653 | Registry Identifier | ICTRP | |
| MET58 | Other Identifier | Sanofi Identifier | |
| 2017-004731-36 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MenACYW | Experimental | Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (pneumococcal conjugate vaccine [10-valent, adsorbed] {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 measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA. |
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| Group 2: Nimenrix | Active Comparator | 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. |
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| Group 3: MenACYW | Experimental | 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 pneumococcal conjugate vaccine (13-valent, adsorbed) [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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACYW conjugate vaccine | Biological | Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | At 30 days post Dose 3 [12 to 18 months of age (MoA)] |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 30 days post Dose 2 (4 MoA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 2031006 | Chlumec nad Cidlinou | 503 51 | Czechia | |||
| Investigational Site Number : 2031013 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40665158 | Derived | Martinon-Torres F, Virta MM, Koski S, de la Cueva IS, Szymanski HT, Bosis S, Draganescu AC, Silfverdal SA, Zambrano B, Dhingra MS, B'Chir S, Syrkina O, Lyabis O, Vasquez GA, Rehm C; MET58 Study Group. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial. Infect Dis Ther. 2025 Aug;14(8):1843-1865. doi: 10.1007/s40121-025-01190-7. Epub 2025 Jul 15. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 1660 participants were enrolled in this study.
This study was conducted at 33 investigational sites in 7 countries between 14 December 2018 to 24 May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: MenACYW | Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (pneumococcal conjugate vaccine [10-valent, adsorbed] {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 measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Dec 27, 2024 |
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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.
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| Group 4: MenACYW | Experimental | 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. |
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| Meningococcal group A, C, W-135, and Y conjugate vaccine | Biological | Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular |
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| DTaP-IPV-HB-Hib vaccine | Biological | Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine |
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| Pneumococcal vaccine (13-valent) | Biological | Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
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| Pneumococcal vaccine (10-valent) | Biological | Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed) |
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| MMR vaccine | Biological | Measles, mumps, and rubella vaccine |
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| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA) |
| 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. | 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) |
| 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. | Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA) |
| 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). | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) |
| 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. | 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) |
| 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. | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) |
| 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. | 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) |
| 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). | 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) |
| 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. | 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) |
| Domažlice |
| 34401 |
| Czechia |
| Investigational Site Number : 2031010 | Jindřichův Hradec | 377 01 | Czechia |
| Investigational Site Number : 2031012 | Jindřichův Hradec | 377 01 | Czechia |
| Investigational Site Number : 2031003 | Ostrava | 702 00 | Czechia |
| Investigational Site Number : 2031008 | Ostrava-hrabuvka | 700 30 | Czechia |
| Investigational Site Number : 2031009 | Pardubice | 530 09 | Czechia |
| Investigational Site Number : 2031005 | Pardubice | 530 12 | Czechia |
| Investigational Site Number : 2031007 | Smiřice | 503 03 | Czechia |
| Investigational Site Number : 2462007 | Espoo | 02230 | Finland |
| Investigational Site Number : 2462003 | Helsinki | 00100 | Finland |
| Investigational Site Number : 2462004 | Helsinki | 00930 | Finland |
| Investigational Site Number : 2462001 | Jarvenpaa | 04400 | Finland |
| Investigational Site Number : 2462006 | Kokkola | 67100 | Finland |
| Investigational Site Number : 2462005 | Oulu | 90220 | Finland |
| Investigational Site Number : 2462002 | Pori | 28100 | Finland |
| Investigational Site Number : 2462009 | Seinäjoki | 60100 | Finland |
| Investigational Site Number : 2462010 | Tampere | 33100 | Finland |
| Investigational Site Number : 2462008 | Turku | 20520 | Finland |
| Investigational Site Number : 3803002 | Milan | 20122 | Italy |
| Investigational Site Number : 6167002 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-090 | Poland |
| Investigational Site Number : 6167004 | Trzebnica | Lower Silesian Voivodeship | 55-100 | Poland |
| Investigational Site Number : 6167003 | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| Investigational Site Number : 6167006 | Torun | 87-100 | Poland |
| Investigational Site Number : 6424003 | Brasov | 500063 | Romania |
| Investigational Site Number : 6424001 | Bucaresti | 21105 | Romania |
| Investigational Site Number : 6424002 | Calarasi | 910160 | Romania |
| Investigational Site Number : 6424006 | Caracal | 235200 | Romania |
| Investigational Site Number : 7245003 | Madrid | Madrid, Comunidad de | 28007 | Spain |
| Investigational Site Number : 7245002 | Madrid | 28046 | Spain |
| Investigational Site Number : 7245001 | Santiago de Compostela | 15706 | Spain |
| Investigational Site Number : 7245006 | Seville | 41014 | Spain |
| Investigational Site Number : 7526001 | Umeå | 901 87 | Sweden |
| FG001 | 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. |
| FG002 | 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 pneumococcal conjugate vaccine (13-valent, adsorbed) [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. |
| FG003 | 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. |
| Safety Analysis Set (SafAS) |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants included study participants for whom an injection group had been allocated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 30 days post Dose 3 [12 to 18 months of age (MoA)] |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 30 days post Dose 2 (4 MoA) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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) |
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Adverse events (AEs), serious adverse events (SAEs) and all-cause mortality (deaths) were collected from the study vaccine administration (Day 0) until 30 days after the last vaccination (Visit 5 [13 to 19 MoA] for Groups 1, 2, and 3 and Visit 6 [13 to 19 MoA] for Group 4), up to 14 to 20 MoA.
Analysis was performed on the safety analysis set (SafAS)which included those participants who had received at least 1 dose of the study vaccine(s) and had any safety data available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 696 | 51 | 696 | 678 | 696 |
| EG001 | 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 | 0 | 706 | 57 | 706 | 680 | 706 |
| EG002 | 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 | 0 | 112 | 8 | 112 | 107 | 112 |
| EG003 | 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. | 0 | 108 | 3 | 108 | 103 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune Thrombocytopenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Congenital Hydronephrosis | Congenital, familial and genetic disorders | MedDra 26.0 | Systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDra 26.0 | Systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDra 26.0 | Systematic Assessment |
| |
| Lymphatic Malformation | Congenital, familial and genetic disorders | MedDra 26.0 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDra 26.0 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDra 26.0 | Systematic Assessment |
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| Anal Stenosis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Food Protein-Induced Enterocolitis Syndrome | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Pain | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Systemic Inflammatory Response Syndrome | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Bronchitis Viral | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Exanthema Subitum | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastroenteritis Adenovirus | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastroenteritis Norovirus | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastroenteritis Rotavirus | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Candidiasis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastrointestinal Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pneumonia Respiratory Syncytial Viral | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Bronchiolitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Syncytial Virus Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Rhinovirus Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Burns Second Degree | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Burns Third Degree | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Exposure To Toxic Agent | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
| |
| Weight Gain Poor | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Testicular Yolk Sac Tumour Stage Iii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 26.0 | Systematic Assessment |
| |
| Clinically Isolated Syndrome | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Petit Mal Epilepsy | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Tubulointerstitial Nephritis | Renal and urinary disorders | MedDra 26.0 | Systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDra 26.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Respiration Abnormal | Respiratory, thoracic and mediastinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDra 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDra 26.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Bruising | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Haematoma | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Induration | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Mass | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Respiratory Tract Infection Viral | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDra 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDra 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Dermatitis Diaper | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDra 26.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 ext: 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2024 | Dec 27, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C538863 | 10-valent pneumococcal vaccine |
| C547294 | PHiD-CV vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D008458 | Measles Vaccine |
| D014765 | Viral Vaccines |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Not Reported |
|
| Unknown |
|
| Multiple origin |
|
| Serogroup C |
|
|
| Serogroup W |
|
|
| Serogroup Y |
|
|
|
Statistical analysis for Serogroup C |
| GMT ratio |
| 4.73 |
| 2-Sided |
| 95 |
| 4.00 |
| 5.58 |
95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers. |
| Non-Inferiority |
The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. |
| Statistical analysis for Serogroup W | Slope | 1.54 | 2-Sided | 95 | 1.33 | 1.78 | 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers. | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. |
| Statistical analysis for Serogroup Y | GMT ratio | 1.78 | 2-Sided | 95 | 1.55 | 2.04 | 95% CI of the GMT ratio was calculated using a normal approximation of log-transformed titers. | Non-Inferiority | The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >1/1.5 for all 4 serogroups. |
|
|
|
| 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. |
|
|
| 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 5MoA] 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG001 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
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.
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| OG001 |
| 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. |
|
|
| OG001 | 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. |
|
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
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