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

Phase 3

Completed

Conditions: Healthy Volunteers (Meningococcal Infection)

Interventions: Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Biological: Haemophilus b Conjugate Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Hepatitis B Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Varicella Virus Vaccine Live

Registration Number: NCT03691610

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.

The secondary objectives of the study are:

* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.

* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.

* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.

* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

Detailed Description: Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 950

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Varicella Virus Vaccine Live	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Hepatitis B Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Measles, Mumps, and Rubella Virus Vaccine Live	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Haemophilus b Conjugate Vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Pneumococcal 13-valent Conjugate Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Rotavirus Vaccine, Live, Oral, Pentavalent	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Rotavirus Vaccine, Live, Oral, Pentavalent	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Measles, Mumps, and Rubella Virus Vaccine Live	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Varicella Virus Vaccine Live	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 3	Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine	MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 1	Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Pneumococcal 13-valent Conjugate Vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 1	Hepatitis B Vaccine	MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2	Haemophilus b Conjugate Vaccine	MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 4	Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine	Menactra® at 17 to 19 months of age and 20 to 23 months of age

Primary Outcome Measures

Name	Time	Method
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a post-vaccination titer \>= 4-fold increase from baseline for participant with pre-vaccination hSBA titer \>= 1:8.

Secondary Outcome Measures

Name	Time	Method
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO	At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers \>= 1:8.
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO	At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination	PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128	PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed.
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y	Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128	Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 to \>= 1:128 were analyzed.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination	At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed.
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8	Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed.
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra	At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra	Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as \>= 4-fold increase from baseline (pre-vaccination) were analyzed.

Trial Locations

Locations (47): Emmaus Research Center, Inc Site Number : 8400019
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Anaheim, California, United States
Brownsboro Park Pediatrics Site Number : 8400039
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Louisville, Kentucky, United States
Velocity Clinical Research Site Number : 8400016
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Metairie, Louisiana, United States
Oklahoma State University - Center for Health Sciences Site Number : 8400110
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Tulsa, Oklahoma, United States
Tekton Research Site Number : 8400047
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Beaumont, Texas, United States
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
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Houston, Texas, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
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Miami, Florida, United States
Biomedical Research LLC Site Number : 8400041
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Miami, Florida, United States
Tekton Research, Inc. Site Number : 8400040
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San Antonio, Texas, United States
Meridian Clinical Research, LLC Site Number : 8400035
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Baton Rouge, Louisiana, United States
Tribe Clinical Research Site Number : 8400118
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Greenville, South Carolina, United States
Snake River Research, PLLC Site Number : 8400058
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Idaho Falls, Idaho, United States
Willis-Knighton Physician Network Site Number : 8400075
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Shreveport, Louisiana, United States
Coastal Pediatric Research Charleston Site Number : 8400002
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Charleston, South Carolina, United States
Midwest Childrens Health Research Institute Site Number : 8400111
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Lincoln, Nebraska, United States
Midwest Childrens Health Research Institute Site Number : 8400117
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Lincoln, Nebraska, United States
Coastal Pediatric Research Charleston Site Number : 8400011
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Charleston, South Carolina, United States
Pediatric Clinical Trials Tullahoma Site Number : 8400106
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Tullahoma, Tennessee, United States
MedPharmics, LLC - Phoenix Site Number : 8400013
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Phoenix, Arizona, United States
Axcess Medical Research Site Number : 8400021
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Loxahatchee Groves, Florida, United States
Crystal Biomedical Research Site Number : 8400034
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Miami Lakes, Florida, United States
Alabama Clinical Therapeutics Site Number : 8400036
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Birmingham, Alabama, United States
Southeastern Pediatric Associates Site Number : 8400009
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Dothan, Alabama, United States
Coast Clinical Trials, LLC Site Number : 8400073
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Bellflower, California, United States
Madera Family Med Group Site Number : 8400065
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Madera, California, United States
Next Phase Research Alliance Site Number : 8400044
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Homestead, Florida, United States
PAS Research Site Number : 8400101
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Land O' Lakes, Florida, United States
PAS Research Site Number : 8400059
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Tampa, Florida, United States
Omega Pediatrics Site Number : 8400093
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Roswell, Georgia, United States
Victory Clinical Research Site Number : 8400026
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Baltimore, Maryland, United States
Pediatric Associates of Fall River Site Number : 8400112
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Fall River, Massachusetts, United States
Craig Spiegel, MD Site Number : 8400023
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Bridgeton, Missouri, United States
Meridian Clinical Research Site Number : 8400097
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Hastings, Nebraska, United States
Advantage Clinical Trials Site Number : 8400069
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New York, New York, United States
MedPharmics Inc Site Number : 8400006
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Albuquerque, New Mexico, United States
Wilmington Health Site Number : 8400054
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Wilmington, North Carolina, United States
Ohio Pediatric Research Site Number : 8400022
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Dayton, Ohio, United States
PriMed Clinical Research Site Number : 8400008
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Dayton, Ohio, United States
Mercury Clinical Research, Inc. Site Number : 8400088
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Dickinson, Texas, United States
Investigational Site Number : 6300102
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Guayama, Puerto Rico
Investigational Site Number : 6300014
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San Juan, Puerto Rico
Matrix Clinical Research Site Number : 8400082
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Gardena, California, United States
All Children Pediatrics Site Number : 8400024
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Louisville, Kentucky, United States
Cyn3rgy Research Site Number : 8400010
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Gresham, Oregon, United States
Kid's Way Pediatrics Site Number : 8400015
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Hermitage, Pennsylvania, United States
Allegheny Health and Wellness Pavilion Site Number : 8400025
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Erie, Pennsylvania, United States
Eagle Clinical Research Site Number : 8400094
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Chicago, Illinois, United States