Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
3 other identifiers
interventional
950
2 countries
47
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2018
Longer than P75 for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedStudy Start
First participant enrolled
October 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedResults Posted
Study results publicly available
June 25, 2024
CompletedJune 25, 2024
June 1, 2024
5 years
September 28, 2018
May 14, 2024
June 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
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.
Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Secondary Outcomes (11)
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
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
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
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
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
- +6 more secondary outcomes
Study Arms (4)
Group 1
EXPERIMENTALMenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 2
ACTIVE COMPARATORMENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Group 3
EXPERIMENTALMenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Group 4
ACTIVE COMPARATORMenactra® at 17 to 19 months of age and 20 to 23 months of age
Interventions
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Eligibility Criteria
You may qualify if:
- Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
- Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
- For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment
You may not qualify if:
- 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 may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes 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, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Alabama Clinical Therapeutics Site Number : 8400036
Birmingham, Alabama, 35205, United States
Southeastern Pediatric Associates Site Number : 8400009
Dothan, Alabama, 36305, United States
MedPharmics, LLC - Phoenix Site Number : 8400013
Phoenix, Arizona, 85015, United States
Emmaus Research Center, Inc Site Number : 8400019
Anaheim, California, 92804, United States
Coast Clinical Trials, LLC Site Number : 8400073
Bellflower, California, 90706, United States
Matrix Clinical Research Site Number : 8400082
Gardena, California, 90247, United States
Madera Family Med Group Site Number : 8400065
Madera, California, 93637, United States
Next Phase Research Alliance Site Number : 8400044
Homestead, Florida, 33030, United States
PAS Research Site Number : 8400101
Land O' Lakes, Florida, 34639, United States
Axcess Medical Research Site Number : 8400021
Loxahatchee Groves, Florida, 33470, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
Miami, Florida, 33144, United States
Biomedical Research LLC Site Number : 8400041
Miami, Florida, 33186, United States
Crystal Biomedical Research Site Number : 8400034
Miami Lakes, Florida, 33014, United States
PAS Research Site Number : 8400059
Tampa, Florida, 33613, United States
Omega Pediatrics Site Number : 8400093
Roswell, Georgia, 30076, United States
Snake River Research, PLLC Site Number : 8400058
Idaho Falls, Idaho, 83404, United States
Eagle Clinical Research Site Number : 8400094
Chicago, Illinois, 60621, United States
Brownsboro Park Pediatrics Site Number : 8400039
Louisville, Kentucky, 40207, United States
All Children Pediatrics Site Number : 8400024
Louisville, Kentucky, 40243, United States
Meridian Clinical Research, LLC Site Number : 8400035
Baton Rouge, Louisiana, 70806, United States
Velocity Clinical Research Site Number : 8400016
Metairie, Louisiana, 70006, United States
Willis-Knighton Physician Network Site Number : 8400075
Shreveport, Louisiana, 71105, United States
Victory Clinical Research Site Number : 8400026
Baltimore, Maryland, 21209, United States
Pediatric Associates of Fall River Site Number : 8400112
Fall River, Massachusetts, 02721, United States
Craig Spiegel, MD Site Number : 8400023
Bridgeton, Missouri, 63044, United States
Meridian Clinical Research Site Number : 8400097
Hastings, Nebraska, 68901, United States
Midwest Childrens Health Research Institute Site Number : 8400111
Lincoln, Nebraska, 68504, United States
Midwest Childrens Health Research Institute Site Number : 8400117
Lincoln, Nebraska, 68505, United States
MedPharmics Inc Site Number : 8400006
Albuquerque, New Mexico, 87102, United States
Advantage Clinical Trials Site Number : 8400069
New York, New York, 10468, United States
Wilmington Health Site Number : 8400054
Wilmington, North Carolina, 28405, United States
Ohio Pediatric Research Site Number : 8400022
Dayton, Ohio, 45414, United States
PriMed Clinical Research Site Number : 8400008
Dayton, Ohio, 45419, United States
Oklahoma State University - Center for Health Sciences Site Number : 8400110
Tulsa, Oklahoma, 74127, United States
Cyn3rgy Research Site Number : 8400010
Gresham, Oregon, 97030, United States
Allegheny Health and Wellness Pavilion Site Number : 8400025
Erie, Pennsylvania, 16505, United States
Kid's Way Pediatrics Site Number : 8400015
Hermitage, Pennsylvania, 16148, United States
Coastal Pediatric Research Charleston Site Number : 8400002
Charleston, South Carolina, 29414, United States
Coastal Pediatric Research Charleston Site Number : 8400011
Charleston, South Carolina, 29414, United States
Tribe Clinical Research Site Number : 8400118
Greenville, South Carolina, 29607, United States
Pediatric Clinical Trials Tullahoma Site Number : 8400106
Tullahoma, Tennessee, 37388, United States
Tekton Research Site Number : 8400047
Beaumont, Texas, 77706, United States
Mercury Clinical Research, Inc. Site Number : 8400088
Dickinson, Texas, 77539, United States
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
Houston, Texas, 77074-2085, United States
Tekton Research, Inc. Site Number : 8400040
San Antonio, Texas, 78240, United States
Investigational Site Number : 6300102
Guayama, 007874, Puerto Rico
Investigational Site Number : 6300014
San Juan, 00918, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi Pasteur
Study Officials
- STUDY DIRECTOR
Clinical Sciences & Operations
Sanofi Pasteur, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 2, 2018
Study Start
October 4, 2018
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
June 25, 2024
Results First Posted
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
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