Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT ID: NCT03691610
Last Updated: 2024-06-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
950 participants
INTERVENTIONAL
2018-10-04
2023-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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®.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
NCT03673462
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT03537508
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
NCT03630705
Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
NCT03077438
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
NCT02199691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Group 2
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Group 3
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Group 4
Menactra® at 17 to 19 months of age and 20 to 23 months of age
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Haemophilus b Conjugate Vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pneumococcal 13-valent Conjugate Vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Rotavirus Vaccine, Live, Oral, Pentavalent
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Hepatitis B Vaccine
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Measles, Mumps, and Rubella Virus Vaccine Live
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Varicella Virus Vaccine Live
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
* 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 that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Any condition which, in the opinion of the investigator, might interfere 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 subject should not be included in the study until the condition has resolved or the febrile event has subsided
* Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
6 Months
19 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama Clinical Therapeutics Site Number : 8400036
Birmingham, Alabama, United States
Southeastern Pediatric Associates Site Number : 8400009
Dothan, Alabama, United States
MedPharmics, LLC - Phoenix Site Number : 8400013
Phoenix, Arizona, United States
Emmaus Research Center, Inc Site Number : 8400019
Anaheim, California, United States
Coast Clinical Trials, LLC Site Number : 8400073
Bellflower, California, United States
Matrix Clinical Research Site Number : 8400082
Gardena, California, United States
Madera Family Med Group Site Number : 8400065
Madera, California, United States
Next Phase Research Alliance Site Number : 8400044
Homestead, Florida, United States
PAS Research Site Number : 8400101
Land O' Lakes, Florida, United States
Axcess Medical Research Site Number : 8400021
Loxahatchee Groves, Florida, United States
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
Miami, Florida, United States
Biomedical Research LLC Site Number : 8400041
Miami, Florida, United States
Crystal Biomedical Research Site Number : 8400034
Miami Lakes, Florida, United States
PAS Research Site Number : 8400059
Tampa, Florida, United States
Omega Pediatrics Site Number : 8400093
Roswell, Georgia, United States
Snake River Research, PLLC Site Number : 8400058
Idaho Falls, Idaho, United States
Eagle Clinical Research Site Number : 8400094
Chicago, Illinois, United States
Brownsboro Park Pediatrics Site Number : 8400039
Louisville, Kentucky, United States
All Children Pediatrics Site Number : 8400024
Louisville, Kentucky, United States
Meridian Clinical Research, LLC Site Number : 8400035
Baton Rouge, Louisiana, United States
Velocity Clinical Research Site Number : 8400016
Metairie, Louisiana, United States
Willis-Knighton Physician Network Site Number : 8400075
Shreveport, Louisiana, United States
Victory Clinical Research Site Number : 8400026
Baltimore, Maryland, United States
Pediatric Associates of Fall River Site Number : 8400112
Fall River, Massachusetts, United States
Craig Spiegel, MD Site Number : 8400023
Bridgeton, Missouri, United States
Meridian Clinical Research Site Number : 8400097
Hastings, Nebraska, United States
Midwest Childrens Health Research Institute Site Number : 8400111
Lincoln, Nebraska, United States
Midwest Childrens Health Research Institute Site Number : 8400117
Lincoln, Nebraska, United States
MedPharmics Inc Site Number : 8400006
Albuquerque, New Mexico, United States
Advantage Clinical Trials Site Number : 8400069
New York, New York, United States
Wilmington Health Site Number : 8400054
Wilmington, North Carolina, United States
Ohio Pediatric Research Site Number : 8400022
Dayton, Ohio, United States
PriMed Clinical Research Site Number : 8400008
Dayton, Ohio, United States
Oklahoma State University - Center for Health Sciences Site Number : 8400110
Tulsa, Oklahoma, United States
Cyn3rgy Research Site Number : 8400010
Gresham, Oregon, United States
Allegheny Health and Wellness Pavilion Site Number : 8400025
Erie, Pennsylvania, United States
Kid's Way Pediatrics Site Number : 8400015
Hermitage, Pennsylvania, United States
Coastal Pediatric Research Charleston Site Number : 8400002
Charleston, South Carolina, United States
Coastal Pediatric Research Charleston Site Number : 8400011
Charleston, South Carolina, United States
Tribe Clinical Research Site Number : 8400118
Greenville, South Carolina, United States
Pediatric Clinical Trials Tullahoma Site Number : 8400106
Tullahoma, Tennessee, United States
Tekton Research Site Number : 8400047
Beaumont, Texas, United States
Mercury Clinical Research, Inc. Site Number : 8400088
Dickinson, Texas, United States
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
Houston, Texas, United States
Tekton Research, Inc. Site Number : 8400040
San Antonio, Texas, United States
Investigational Site Number : 6300102
Guayama, , Puerto Rico
Investigational Site Number : 6300014
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1205-2836
Identifier Type: REGISTRY
Identifier Source: secondary_id
MET61
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004460-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MET61
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.