Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers (Meningococcal Infection)
• Intervention / Treatment: Biological: MenACYW conjugate vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Varicella vaccine; Biological: Hepatitis A vaccine; Biological: MenACYW-135 conjugate vaccine; Biological: DTaP-IPV//Hib vaccine

Detailed Description

The duration of each subject's participation in the trial was approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which included a safety follow up contact at 6 months after the last vaccinations.

• Study Type: Interventional
• Enrollment (Actual): 2627
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00726
    • Investigational Site Number : 6300116
  • Guayama, Puerto Rico, 000784
    • Investigational Site Number : 6300122
  • San Juan, Puerto Rico, 00918
    • Investigational Site Number : 6300015
  • San Juan, Puerto Rico, 00918
    • Investigational Site Number : 6300117
  • San Juan, Puerto Rico, 00935
    • Investigational Site Number : 6300140
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates Site Number : 8400026
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates Site Number : 8400003
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • MedPharmics, LLC - Phoenix Site Number : 8400083
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatric Clinic Site Number : 8400011
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, PA Site Number : 8400032
  • California
    • Anaheim, California, United States, 92804
      • Emmaus Research Center, Inc Site Number : 8400031
    • Downey, California, United States, 90241
      • Premier Health Research Center Site Number : 8400007
    • Huntington Park, California, United States, 90255
      • Joint Clinical Trials Huntington Park Site Number : 8400126
    • Huntington Park, California, United States, 90255
      • United Clinical Research Site Number : 8400092
    • Los Angeles, California, United States, 90057
      • Matrix Clinical Research Site Number : 8400095
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC Site Number : 8400030
    • West Covina, California, United States, 91790
      • Center for Clinical Trials of San Gabriel Site Number : 8400076
  • Florida
    • Brooksville, Florida, United States, 34613
      • Asclepes Research Centers Site Number : 8400064
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research Site Number : 8400077
    • Hialeah, Florida, United States, 33013
      • Next Phase Research Alliance Site Number : 8400057
    • Homestead, Florida, United States, 33030
      • Homestead Medical Clinic, P.A. Site Number : 8400014
    • Homestead, Florida, United States, 33030
      • Next Phase Research Alliance Site Number : 8400040
    • Lake Mary, Florida, United States, 32746
      • Children's Research, LLC Site Number : 8400063
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research Site Number : 8400068
    • Miami, Florida, United States, 33186
      • Acevedo Clinical Research Associates Site Number : 8400001
    • Orlando, Florida, United States, 32803
      • Florida Hospital Medical Group Pediatrics Site Number : 8400108
    • Palmetto Bay, Florida, United States, 33157
      • IMIC Inc Site Number : 8400022
    • Tampa, Florida, United States, 33617
      • Jedidiah Clinical Research Site Number : 8400132
  • Georgia
    • Chamblee, Georgia, United States, 30341
      • Baybol Research Institute Site Number : 8400008
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Snake River Research, PLLC Site Number : 8400073
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC Site Number : 8400106
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Brownsboro Park Pediatrics Site Number : 8400010
    • Louisville, Kentucky, United States, 40243
      • All Children Pediatrics Site Number : 8400043
  • Louisiana
    • Haughton, Louisiana, United States, 71037
      • ACC Pediatric Reasearch Site Number : 8400023
    • Metairie, Louisiana, United States, 70006
      • Velocity Clinical Research Site Number : 8400025
    • Shreveport, Louisiana, United States, 71103
      • LSUHSC-Shreveport Site Number : 8400120
  • Maryland
    • Frederick, Maryland, United States, 21702
      • University of Maryland at The Pediatric Center of Frederick Site Number : 8400004
    • Silver Spring, Maryland, United States, 20910
      • Virgo-Carter Pediatrics Site Number : 8400041
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • MedPharmics Biloxi Site Number : 8400080
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Craig Spiegel, MD Site Number : 8400037
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Site Number : 8400039
  • New York
    • New York, New York, United States, 10467
      • Tiga Pediatrics Site Number : 8400137
  • North Carolina
    • Boone, North Carolina, United States, 28607
      • Blue Pediatric & Adolescent Medicine Group Site Number : 8400100
  • Ohio
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Site Number : 8400084
    • Dayton, Ohio, United States, 454429
      • PriMed Clinical Research Site Number : 8400002
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research Site Number : 8400085
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16505
      • Allegheny Health and Wellness Pavilion Site Number : 8400047
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research Charleston Site Number : 8400005
    • Greenville, South Carolina, United States, 29607
      • Tribe Clinical Research Site Number : 8400110
    • Simpsonville, South Carolina, United States, 29681
      • Parkside Pediatrics - Simpsonville Site Number : 8400113
  • Tennessee
    • Tullahoma, Tennessee, United States, 37388
      • Pediatric Clinical Trials Tullahoma Site Number : 8400033
  • Texas
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Wilson Parke Site Number : 8400059
    • Dallas, Texas, United States, 75218
      • Oak Cliff Research Company, LLC Site Number : 8400065
    • Fort Worth, Texas, United States, 76104
      • Helios Clinical research Site Number : 8400075
    • Fort Worth, Texas, United States, 76107-2699
      • University of North Texas Site Number : 8400079
    • Galveston, Texas, United States, 77555-0163
      • University of Texas Medical Board Site Number : 8400067
    • Houston, Texas, United States, 77008
      • Helios Clinical Research Site Number : 8400109
    • Houston, Texas, United States, 77074-2085
      • Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114
    • Lampasas, Texas, United States, 76550
      • FMC SCIENCE Site Number : 8400053
    • San Antonio, Texas, United States, 78229
      • Tekton Research, Inc Site Number : 8400049
    • San Antonio, Texas, United States, 78244
      • Tekton Research Site Number : 8400128
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development Site Number : 8400016
    • Kaysville, Utah, United States, 84037
      • Wee Care Pediatrics Site Number : 8400035
    • Layton, Utah, United States, 84041
      • Tanner Clinic Site Number : 8400018
    • Provo, Utah, United States, 84064
      • Pediatric Care Site Number : 8400056
    • Roy, Utah, United States, 84067
      • Wee Care Pediatrics Roy Site Number : 8400029
    • South Jordan, Utah, United States, 84095
      • Copperview Medical Center Site Number : 8400038
    • Syracuse, Utah, United States, 84075-9645
      • Alliance for Multispecialty Research Syracuse Site Number : 8400036
    • Syracuse, Utah, United States, 84075-9143
      • Wee Care Pediatrics Syracuse Site Number : 8400024
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Health Site Number : 8400062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 months (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
• Healthy infants as determined by medical history, physical examination, and judgment of the investigator
• Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations
• Participant and parent/guardian were able to attend all scheduled visits and to comply with all trial procedures.
• Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit

Exclusion Criteria:

• Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
• Receipt of more than 1 previous dose of hepatitis B vaccine
• Receipt of immune globulins, blood, or blood-derived products since birth
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
• Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
• Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
• Individuals with active tuberculosis
• History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
• History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
• At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
• History of intussusception
• History of any neurologic disorders, including any seizures and progressive neurologic disorders
• History of Guillain-Barré syndrome
• Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
• Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that in the opinion of the investigator, was at a stage where it might have interfered with trial conduct or completion
• Any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant was not included in the study until the condition has been resolved or the febrile event has been subsided
• Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
• The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1a; MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age	Biological: MenACYW conjugate vaccine; Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular; Biological: Pneumococcal 13-valent conjugate vaccine; Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular; Other Names: PREVNAR 13®; Biological: Pentavalent rotavirus vaccine; Rotavirus vaccine at 2, 4, and 6 months of age, oral solution; Other Names: RotaTeq®; Biological: Hepatitis B vaccine; Hepatitis B vaccine at 2 and 6 months of age, Intramuscular; Other Names: ENGERIX-B®; Biological: Measles, mumps, rubella (MMR) vaccine; MMR vaccine at 12 months of age, Subcutaneous; Other Names: M-M-R® II; Biological: Varicella vaccine; Varicella vaccine at 12 months of age; Other Names: VARIVAX®; Biological: DTaP-IPV//Hib vaccine; DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular; Other Names: Pentacel®
Experimental: Group 1b; 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	Biological: MenACYW conjugate vaccine; Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular; Biological: Pneumococcal 13-valent conjugate vaccine; Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular; Other Names: PREVNAR 13®; Biological: Pentavalent rotavirus vaccine; Rotavirus vaccine at 2, 4, and 6 months of age, oral solution; Other Names: RotaTeq®; Biological: Hepatitis B vaccine; Hepatitis B vaccine at 2 and 6 months of age, Intramuscular; Other Names: ENGERIX-B®; Biological: Measles, mumps, rubella (MMR) vaccine; MMR vaccine at 12 months of age, Subcutaneous; Other Names: M-M-R® II; Biological: Varicella vaccine; Varicella vaccine at 12 months of age; Other Names: VARIVAX®; Biological: Hepatitis A vaccine; Hepatitis A vaccine at 15 to 18 months of age; Other Names: HAVRIX®; Biological: DTaP-IPV//Hib vaccine; DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular; Other Names: Pentacel®
Active Comparator: Group 2a; 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	Biological: Pneumococcal 13-valent conjugate vaccine; Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular; Other Names: PREVNAR 13®; Biological: Pentavalent rotavirus vaccine; Rotavirus vaccine at 2, 4, and 6 months of age, oral solution; Other Names: RotaTeq®; Biological: Hepatitis B vaccine; Hepatitis B vaccine at 2 and 6 months of age, Intramuscular; Other Names: ENGERIX-B®; Biological: Measles, mumps, rubella (MMR) vaccine; MMR vaccine at 12 months of age, Subcutaneous; Other Names: M-M-R® II; Biological: Varicella vaccine; Varicella vaccine at 12 months of age; Other Names: VARIVAX®; Biological: MenACYW-135 conjugate vaccine; Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular; Other Names: MENVEO®; Biological: DTaP-IPV//Hib vaccine; DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular; Other Names: Pentacel®
Active Comparator: Group 2b; 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	Biological: Pneumococcal 13-valent conjugate vaccine; Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular; Other Names: PREVNAR 13®; Biological: Pentavalent rotavirus vaccine; Rotavirus vaccine at 2, 4, and 6 months of age, oral solution; Other Names: RotaTeq®; Biological: Hepatitis B vaccine; Hepatitis B vaccine at 2 and 6 months of age, Intramuscular; Other Names: ENGERIX-B®; Biological: Measles, mumps, rubella (MMR) vaccine; MMR vaccine at 12 months of age, Subcutaneous; Other Names: M-M-R® II; Biological: Varicella vaccine; Varicella vaccine at 12 months of age; Other Names: VARIVAX®; Biological: Hepatitis A vaccine; Hepatitis A vaccine at 15 to 18 months of age; Other Names: HAVRIX®; Biological: MenACYW-135 conjugate vaccine; Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular; Other Names: MENVEO®; Biological: DTaP-IPV//Hib vaccine; DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular; Other Names: Pentacel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company
• Investigators: Study Director: Medical Director, Sanofi Pasteur, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Meningococcal meningitis; MenACYW conjugate vaccine; Quadrivalent meningococcal vaccine
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MET42; U1111-1183-6361 (Registry Identifier: ICTRP); 2018-001473-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No