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

PHASE3CompletedINTERVENTIONAL
Enrollment

950

Participants

Timeline

Start Date

October 4, 2018

Primary Completion Date

October 20, 2023

Study Completion Date

October 20, 2023

Conditions
Healthy Volunteers (Meningococcal Infection)
Interventions
BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

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

BIOLOGICAL

Haemophilus b Conjugate Vaccine

Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Rotavirus Vaccine, Live, Oral, Pentavalent

Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine Live

Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL

BIOLOGICAL

Varicella Virus Vaccine Live

Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL

Trial Locations (47)

10468

Advantage Clinical Trials Site Number : 8400069, New York

16148

Kid's Way Pediatrics Site Number : 8400015, Hermitage

16505

Allegheny Health and Wellness Pavilion Site Number : 8400025, Erie

21209

Victory Clinical Research Site Number : 8400026, Baltimore

28405

Wilmington Health Site Number : 8400054, Wilmington

29414

Coastal Pediatric Research Charleston Site Number : 8400002, Charleston

Coastal Pediatric Research Charleston Site Number : 8400011, Charleston

29607

Tribe Clinical Research Site Number : 8400118, Greenville

30076

Omega Pediatrics Site Number : 8400093, Roswell

33014

Crystal Biomedical Research Site Number : 8400034, Miami Lakes

33030

Next Phase Research Alliance Site Number : 8400044, Homestead

33144

Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046, Miami

33186

Biomedical Research LLC Site Number : 8400041, Miami

33470

Axcess Medical Research Site Number : 8400021, Loxahatchee Groves

33613

PAS Research Site Number : 8400059, Tampa

34639

PAS Research Site Number : 8400101, Land O' Lakes

35205

Alabama Clinical Therapeutics Site Number : 8400036, Birmingham

36305

Southeastern Pediatric Associates Site Number : 8400009, Dothan

37388

Pediatric Clinical Trials Tullahoma Site Number : 8400106, Tullahoma

40207

Brownsboro Park Pediatrics Site Number : 8400039, Louisville

40243

All Children Pediatrics Site Number : 8400024, Louisville

45414

Ohio Pediatric Research Site Number : 8400022, Dayton

45419

PriMed Clinical Research Site Number : 8400008, Dayton

60621

Eagle Clinical Research Site Number : 8400094, Chicago

63044

Craig Spiegel, MD Site Number : 8400023, Bridgeton

68504

Midwest Childrens Health Research Institute Site Number : 8400111, Lincoln

68505

Midwest Childrens Health Research Institute Site Number : 8400117, Lincoln

68901

Meridian Clinical Research Site Number : 8400097, Hastings

70006

Velocity Clinical Research Site Number : 8400016, Metairie

70806

Meridian Clinical Research, LLC Site Number : 8400035, Baton Rouge

71105

Willis-Knighton Physician Network Site Number : 8400075, Shreveport

74127

Oklahoma State University - Center for Health Sciences Site Number : 8400110, Tulsa

77539

Mercury Clinical Research, Inc. Site Number : 8400088, Dickinson

77706

Tekton Research Site Number : 8400047, Beaumont

78240

Tekton Research, Inc. Site Number : 8400040, San Antonio

83404

Snake River Research, PLLC Site Number : 8400058, Idaho Falls

85015

MedPharmics, LLC - Phoenix Site Number : 8400013, Phoenix

87102

MedPharmics Inc Site Number : 8400006, Albuquerque

90247

Matrix Clinical Research Site Number : 8400082, Gardena

90706

Coast Clinical Trials, LLC Site Number : 8400073, Bellflower

92804

Emmaus Research Center, Inc Site Number : 8400019, Anaheim

93637

Madera Family Med Group Site Number : 8400065, Madera

97030

Cyn3rgy Research Site Number : 8400010, Gresham

02721

Pediatric Associates of Fall River Site Number : 8400112, Fall River

77074-2085

Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037, Houston

007874

Investigational Site Number : 6300102, Guayama

00918

Investigational Site Number : 6300014, San Juan

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03691610 - Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers | Biotech Hunter | Biotech Hunter