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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1183-6361 | Registry Identifier | ICTRP | |
| 2018-001473-24 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a | Experimental | MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age |
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| Group 1b | Experimental | MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age |
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| Group 2a | Active Comparator | MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age |
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| Group 2b |
| 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 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. | Day 30 post 12-month vaccination (Month 13) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Associates Site Number : 8400026 | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates Site Number : 8400003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41337697 | Derived | Campbell JD, Gupta S, Dhingra MS, Zambrano B, Gan L, B'Chir S, Chaix J, Syrkina O, Masson J, Liabis O, Rehm C. A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico. Hum Vaccin Immunother. 2025 Dec;21(1):2588874. doi: 10.1080/21645515.2025.2588874. Epub 2025 Dec 3. |
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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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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: MenACYW Conjugate Vaccine | Participants received MenACYW conjugate vaccine 0.5 milliliter (mL) as an intramuscular (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. |
| 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 | Jan 26, 2022 | Aug 23, 2024 |
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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.
MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age |
|
| MenACYW-135 conjugate vaccine | Biological | Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular |
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| DTaP-IPV//Hib vaccine | Biological | 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 |
|
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| Pneumococcal 13-valent conjugate vaccine | Biological | Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular |
|
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| Pentavalent rotavirus vaccine | Biological | Rotavirus vaccine at 2, 4, and 6 months of age, oral solution |
|
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| Hepatitis B vaccine | Biological | Hepatitis B vaccine at 2 and 6 months of age, Intramuscular |
|
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| Measles, mumps, rubella (MMR) vaccine | Biological | MMR vaccine at 12 months of age, Subcutaneous |
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| Varicella vaccine | Biological | Varicella vaccine at 12 months of age |
|
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| Hepatitis A vaccine | Biological | Hepatitis A vaccine at 15 to 18 months of age |
|
|
| Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 6-month vaccination (Month 7) |
| 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. | Day 30 post 12-month vaccination (Month 13) |
| 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. | Day 30 post 12-month vaccination (Month 13) |
| 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. | Day 30 post 12-month vaccination (Month 13) |
| 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. | Day 30 post 15-month vaccination (Month 16) |
| 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. | Day 30 post 15-month vaccination (Month 16) |
| 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. | Day 30 post 15-month vaccination (Month 16) |
| 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. | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) |
| 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. | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) |
| Dothan |
| Alabama |
| 36305 |
| United States |
| MedPharmics, LLC - Phoenix Site Number : 8400083 | Phoenix | Arizona | 85015 | United States |
| Northwest Arkansas Pediatric Clinic Site Number : 8400011 | Fayetteville | Arkansas | 72703 | United States |
| The Children's Clinic of Jonesboro, PA Site Number : 8400032 | Jonesboro | Arkansas | 72401 | United States |
| Emmaus Research Center, Inc Site Number : 8400031 | Anaheim | California | 92804 | United States |
| Premier Health Research Center Site Number : 8400007 | Downey | California | 90241 | United States |
| Joint Clinical Trials Huntington Park Site Number : 8400126 | Huntington Park | California | 90255 | United States |
| United Clinical Research Site Number : 8400092 | Huntington Park | California | 90255 | United States |
| Matrix Clinical Research Site Number : 8400095 | Los Angeles | California | 90057 | United States |
| Center for Clinical Trials, LLC Site Number : 8400030 | Paramount | California | 90723 | United States |
| Center for Clinical Trials of San Gabriel Site Number : 8400076 | West Covina | California | 91790 | United States |
| Asclepes Research Centers Site Number : 8400064 | Brooksville | Florida | 34613 | United States |
| Avail Clinical Research Site Number : 8400077 | DeLand | Florida | 32720 | United States |
| Next Phase Research Alliance Site Number : 8400057 | Hialeah | Florida | 33013 | United States |
| Homestead Medical Clinic, P.A. Site Number : 8400014 | Homestead | Florida | 33030 | United States |
| Next Phase Research Alliance Site Number : 8400040 | Homestead | Florida | 33030 | United States |
| Children's Research, LLC Site Number : 8400063 | Lake Mary | Florida | 32746 | United States |
| Axcess Medical Research Site Number : 8400068 | Loxahatchee Groves | Florida | 33470 | United States |
| Acevedo Clinical Research Associates Site Number : 8400001 | Miami | Florida | 33186 | United States |
| Florida Hospital Medical Group Pediatrics Site Number : 8400108 | Orlando | Florida | 32803 | United States |
| IMIC Inc Site Number : 8400022 | Palmetto Bay | Florida | 33157 | United States |
| Jedidiah Clinical Research Site Number : 8400132 | Tampa | Florida | 33617 | United States |
| Baybol Research Institute Site Number : 8400008 | Chamblee | Georgia | 30341 | United States |
| Snake River Research, PLLC Site Number : 8400073 | Idaho Falls | Idaho | 83404 | United States |
| Qualmedica Research, LLC Site Number : 8400106 | Evansville | Indiana | 47715 | United States |
| Brownsboro Park Pediatrics Site Number : 8400010 | Louisville | Kentucky | 40207 | United States |
| All Children Pediatrics Site Number : 8400043 | Louisville | Kentucky | 40243 | United States |
| ACC Pediatric Reasearch Site Number : 8400023 | Haughton | Louisiana | 71037 | United States |
| Velocity Clinical Research Site Number : 8400025 | Metairie | Louisiana | 70006 | United States |
| LSUHSC-Shreveport Site Number : 8400120 | Shreveport | Louisiana | 71103 | United States |
| University of Maryland at The Pediatric Center of Frederick Site Number : 8400004 | Frederick | Maryland | 21702 | United States |
| Virgo-Carter Pediatrics Site Number : 8400041 | Silver Spring | Maryland | 20910 | United States |
| MedPharmics Biloxi Site Number : 8400080 | Biloxi | Mississippi | 39531 | United States |
| Craig Spiegel, MD Site Number : 8400037 | Bridgeton | Missouri | 63044 | United States |
| Creighton University Site Number : 8400039 | Omaha | Nebraska | 68131 | United States |
| Tiga Pediatrics Site Number : 8400137 | New York | New York | 10467 | United States |
| Blue Pediatric & Adolescent Medicine Group Site Number : 8400100 | Boone | North Carolina | 28607 | United States |
| Ohio Pediatric Research Site Number : 8400084 | Dayton | Ohio | 45414 | United States |
| PriMed Clinical Research Site Number : 8400002 | Dayton | Ohio | 454429 | United States |
| Cyn3rgy Research Site Number : 8400085 | Gresham | Oregon | 97030 | United States |
| Allegheny Health and Wellness Pavilion Site Number : 8400047 | Erie | Pennsylvania | 16505 | United States |
| Coastal Pediatric Research Charleston Site Number : 8400005 | Charleston | South Carolina | 29414 | United States |
| Tribe Clinical Research Site Number : 8400110 | Greenville | South Carolina | 29607 | United States |
| Parkside Pediatrics - Simpsonville Site Number : 8400113 | Simpsonville | South Carolina | 29681 | United States |
| Pediatric Clinical Trials Tullahoma Site Number : 8400033 | Tullahoma | Tennessee | 37388 | United States |
| ARC Clinical Research at Wilson Parke Site Number : 8400059 | Austin | Texas | 78726 | United States |
| Oak Cliff Research Company, LLC Site Number : 8400065 | Dallas | Texas | 75218 | United States |
| Helios Clinical research Site Number : 8400075 | Fort Worth | Texas | 76104 | United States |
| University of North Texas Site Number : 8400079 | Fort Worth | Texas | 76107-2699 | United States |
| University of Texas Medical Board Site Number : 8400067 | Galveston | Texas | 77555-0163 | United States |
| Helios Clinical Research Site Number : 8400109 | Houston | Texas | 77008 | United States |
| Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114 | Houston | Texas | 77074-2085 | United States |
| FMC SCIENCE Site Number : 8400053 | Lampasas | Texas | 76550 | United States |
| Tekton Research, Inc Site Number : 8400049 | San Antonio | Texas | 78229 | United States |
| Tekton Research Site Number : 8400128 | San Antonio | Texas | 78244 | United States |
| Ericksen Research and Development Site Number : 8400016 | Clinton | Utah | 84015 | United States |
| Wee Care Pediatrics Site Number : 8400035 | Kaysville | Utah | 84037 | United States |
| Tanner Clinic Site Number : 8400018 | Layton | Utah | 84041 | United States |
| Pediatric Care Site Number : 8400056 | Provo | Utah | 84064 | United States |
| Wee Care Pediatrics Roy Site Number : 8400029 | Roy | Utah | 84067 | United States |
| Copperview Medical Center Site Number : 8400038 | South Jordan | Utah | 84095 | United States |
| Wee Care Pediatrics Syracuse Site Number : 8400024 | Syracuse | Utah | 84075-9143 | United States |
| Alliance for Multispecialty Research Syracuse Site Number : 8400036 | Syracuse | Utah | 84075-9645 | United States |
| Marshall Health Site Number : 8400062 | Huntington | West Virginia | 25701 | United States |
| Investigational Site Number : 6300116 | Caguas | 00726 | Puerto Rico |
| Investigational Site Number : 6300122 | Guayama | 000784 | Puerto Rico |
| Investigational Site Number : 6300015 | San Juan | 00918 | Puerto Rico |
| Investigational Site Number : 6300117 | San Juan | 00918 | Puerto Rico |
| Investigational Site Number : 6300140 | San Juan | 00935 | Puerto Rico |
| FG001 | 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. |
| Safety Analysis Set (SafAS) |
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| Vaccinated at 2 Months |
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| Vaccinated at 4 Months |
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| Vaccinated at 6 Months |
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| Vaccinated at 12 Months |
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| Vaccinated at 15 Months |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were assessed for all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| 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 (NIH/OMB) | 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 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 12-month vaccination (Month 13) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Units/mL | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | ELISA units/mL | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Day 30 post 6-month vaccination (Month 7) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 12-month vaccination (Month 13) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 12-month vaccination (Month 13) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Day 30 post 12-month vaccination (Month 13) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 15-month vaccination (Month 16) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 15-month vaccination (Month 16) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 15-month vaccination (Month 16) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) |
|
From first administration of study treatment (Day 0) up to 6-months post last administration of study treatment, approximately 24 months for Group 1 and 18 months for Group 2.
Analysis was performed on safety analysis set which was defined as those participants who received at least 1 dose of the study vaccines and had any safety data available. All participants had safety analyzed according to the vaccine received post first dose.
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 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 | 1,727 | 99 | 1,727 | 1,471 | 1,727 |
| EG001 | 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. | 0 | 867 | 38 | 867 | 746 | 867 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post Vaccination Fever | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skull Fractured Base | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Congenital Absence Of Bile Ducts | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyloric Stenosis | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urachal Abnormality | Congenital, familial and genetic disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Febrile Convulsion | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Infantile Spasms | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Seizure Like Phenomena | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Subarachnoid Haemorrhage | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sandifer's Syndrome | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Type 1 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abscess Neck | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacterial Pyelonephritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bordetella Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Croup Infectious | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema Coxsackium | 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 Norovirus | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrointestinal Viral Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Otitis Media Acute | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Parainfluenzae Virus Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Perirectal Abscess | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia Viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | 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 |
| |
| Roseola | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin Bacterial Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Staphylococcal Scalded Skin Syndrome | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Systemic Viral Infection | 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 Infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | 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 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 |
| |
| Irritability | Psychiatric 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 aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 22, 2024 | Aug 23, 2024 | SAP_001.pdf |
Not provided
| 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 |
|---|---|
| D022401 | Meningococcal Vaccines |
| C512971 | pentacel |
| C538862 | 13-valent pneumococcal vaccine |
| C492535 | RotaTeq |
| D017325 | Hepatitis B Vaccines |
| C075654 | Engerix-B |
| D022542 | Measles-Mumps-Rubella Vaccine |
| D019433 | Chickenpox Vaccine |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| D012411 | Rubella Vaccine |
| D022283 | Herpesvirus Vaccines |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Serogroup C |
|
|
| Serogroup Y |
|
|
| Serogroup W |
|
|
Statistical analysis for Serogroup C |
| Difference in Percentage of Participants |
| 8.75 |
| 2-Sided |
| 95 |
| 4.80 |
| 13.60 |
| Non-Inferiority |
The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction. |
| Statistical analysis for Serogroup Y | Difference in Percentage of Participants | 4.09 | 2-Sided | 95 | 0.68 | 8.44 | Non-Inferiority | The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction. |
| Statistical analysis for Serogroup W | Difference in Percentage of Participants | 1.19 | 2-Sided | 95 | -1.18 | 4.45 | Non-Inferiority | The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all 4 serogroups. 95% CI of the difference was calculated from the Wilson Score method without continuity correction. |
| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| OG001 | 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. |
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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. |
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| OG001 | 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. |
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| OG001 | 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. |
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| Group 2a: MENVEO (Post 12- Month Vaccination) |
Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination. |
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Participants received MENVEO at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age. The time of analyses as well as the collection of blood samples conducted in the 2nd year of life for this subgroup was 30 days after the 12-month vaccination.
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