Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
NCT ID: NCT03537508
Last Updated: 2024-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2627 participants
INTERVENTIONAL
2018-04-25
2023-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
MenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
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
Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine
Varicella vaccine at 12 months of age
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
MenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
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
Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine
Varicella vaccine at 12 months of age
Hepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age
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
MenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
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
Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine
Varicella vaccine at 12 months of age
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
MenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
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
Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine
Varicella vaccine at 12 months of age
Hepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age
Interventions
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MenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
MenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
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
Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age, Subcutaneous
Varicella vaccine
Varicella vaccine at 12 months of age
Hepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
42 Days
89 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Birmingham Pediatric Associates Site Number : 8400026
Birmingham, Alabama, United States
Southeastern Pediatric Associates Site Number : 8400003
Dothan, Alabama, United States
MedPharmics, LLC - Phoenix Site Number : 8400083
Phoenix, Arizona, United States
Northwest Arkansas Pediatric Clinic Site Number : 8400011
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro, PA Site Number : 8400032
Jonesboro, Arkansas, United States
Emmaus Research Center, Inc Site Number : 8400031
Anaheim, California, United States
Premier Health Research Center Site Number : 8400007
Downey, California, United States
Joint Clinical Trials Huntington Park Site Number : 8400126
Huntington Park, California, United States
United Clinical Research Site Number : 8400092
Huntington Park, California, United States
Matrix Clinical Research Site Number : 8400095
Los Angeles, California, United States
Center for Clinical Trials, LLC Site Number : 8400030
Paramount, California, United States
Center for Clinical Trials of San Gabriel Site Number : 8400076
West Covina, California, United States
Asclepes Research Centers Site Number : 8400064
Brooksville, Florida, United States
Avail Clinical Research Site Number : 8400077
DeLand, Florida, United States
Next Phase Research Alliance Site Number : 8400057
Hialeah, Florida, United States
Homestead Medical Clinic, P.A. Site Number : 8400014
Homestead, Florida, United States
Next Phase Research Alliance Site Number : 8400040
Homestead, Florida, United States
Children's Research, LLC Site Number : 8400063
Lake Mary, Florida, United States
Axcess Medical Research Site Number : 8400068
Loxahatchee Groves, Florida, United States
Acevedo Clinical Research Associates Site Number : 8400001
Miami, Florida, United States
Florida Hospital Medical Group Pediatrics Site Number : 8400108
Orlando, Florida, United States
IMIC Inc Site Number : 8400022
Palmetto Bay, Florida, United States
Jedidiah Clinical Research Site Number : 8400132
Tampa, Florida, United States
Baybol Research Institute Site Number : 8400008
Chamblee, Georgia, United States
Snake River Research, PLLC Site Number : 8400073
Idaho Falls, Idaho, United States
Qualmedica Research, LLC Site Number : 8400106
Evansville, Indiana, United States
Brownsboro Park Pediatrics Site Number : 8400010
Louisville, Kentucky, United States
All Children Pediatrics Site Number : 8400043
Louisville, Kentucky, United States
ACC Pediatric Reasearch Site Number : 8400023
Haughton, Louisiana, United States
Velocity Clinical Research Site Number : 8400025
Metairie, Louisiana, United States
LSUHSC-Shreveport Site Number : 8400120
Shreveport, Louisiana, United States
University of Maryland at The Pediatric Center of Frederick Site Number : 8400004
Frederick, Maryland, United States
Virgo-Carter Pediatrics Site Number : 8400041
Silver Spring, Maryland, United States
MedPharmics Biloxi Site Number : 8400080
Biloxi, Mississippi, United States
Craig Spiegel, MD Site Number : 8400037
Bridgeton, Missouri, United States
Creighton University Site Number : 8400039
Omaha, Nebraska, United States
Tiga Pediatrics Site Number : 8400137
New York, New York, United States
Blue Pediatric & Adolescent Medicine Group Site Number : 8400100
Boone, North Carolina, United States
Ohio Pediatric Research Site Number : 8400084
Dayton, Ohio, United States
PriMed Clinical Research Site Number : 8400002
Dayton, Ohio, United States
Cyn3rgy Research Site Number : 8400085
Gresham, Oregon, United States
Allegheny Health and Wellness Pavilion Site Number : 8400047
Erie, Pennsylvania, United States
Coastal Pediatric Research Charleston Site Number : 8400005
Charleston, South Carolina, United States
Tribe Clinical Research Site Number : 8400110
Greenville, South Carolina, United States
Parkside Pediatrics - Simpsonville Site Number : 8400113
Simpsonville, South Carolina, United States
Pediatric Clinical Trials Tullahoma Site Number : 8400033
Tullahoma, Tennessee, United States
ARC Clinical Research at Wilson Parke Site Number : 8400059
Austin, Texas, United States
Oak Cliff Research Company, LLC Site Number : 8400065
Dallas, Texas, United States
Helios Clinical research Site Number : 8400075
Fort Worth, Texas, United States
University of North Texas Site Number : 8400079
Fort Worth, Texas, United States
University of Texas Medical Board Site Number : 8400067
Galveston, Texas, United States
Helios Clinical Research Site Number : 8400109
Houston, Texas, United States
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114
Houston, Texas, United States
FMC SCIENCE Site Number : 8400053
Lampasas, Texas, United States
Tekton Research, Inc Site Number : 8400049
San Antonio, Texas, United States
Tekton Research Site Number : 8400128
San Antonio, Texas, United States
Ericksen Research and Development Site Number : 8400016
Clinton, Utah, United States
Wee Care Pediatrics Site Number : 8400035
Kaysville, Utah, United States
Tanner Clinic Site Number : 8400018
Layton, Utah, United States
Pediatric Care Site Number : 8400056
Provo, Utah, United States
Wee Care Pediatrics Roy Site Number : 8400029
Roy, Utah, United States
Copperview Medical Center Site Number : 8400038
South Jordan, Utah, United States
Wee Care Pediatrics Syracuse Site Number : 8400024
Syracuse, Utah, United States
Alliance for Multispecialty Research Syracuse Site Number : 8400036
Syracuse, Utah, United States
Marshall Health Site Number : 8400062
Huntington, West Virginia, United States
Investigational Site Number : 6300116
Caguas, , Puerto Rico
Investigational Site Number : 6300122
Guayama, , Puerto Rico
Investigational Site Number : 6300015
San Juan, , Puerto Rico
Investigational Site Number : 6300117
San Juan, , Puerto Rico
Investigational Site Number : 6300140
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1183-6361
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-001473-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MET42
Identifier Type: -
Identifier Source: org_study_id
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