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

PHASE3CompletedINTERVENTIONAL
Enrollment

2,797

Participants

Timeline

Start Date

September 17, 2018

Primary Completion Date

March 16, 2023

Study Completion Date

March 16, 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: Liquid solution. Route of administration: Intramuscular

BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)

Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

BIOLOGICAL

Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine

Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

BIOLOGICAL

Pneumococcal 13-valent Conjugate Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Rotavirus Vaccine

Pharmaceutical form: Oral solution Route of administration: Oral

BIOLOGICAL

Hepatitis B Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

BIOLOGICAL

Measles, Mumps, and Rubella Virus Vaccine

Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

BIOLOGICAL

Varicella Virus Vaccine

Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

Trial Locations (69)

14618

Legacy Pediatrics-Site Number:8400004, Rochester

22902

Pediatric Medical Research of Charlottesville-Site Number:8400077, Charlottesville

27103

Ford, Simpson, Lively & Rice Pediatrics-Site Number:8400021, Winston-Salem

27360

Medication Management-Site Number:8400072, Greensboro

29406

Palmetto Pediatrics, PA-Site Number:8400089, North Charleston

29414

Coastal Pediatric Research Charleston-Site Number:8400037, Charleston

29464

PMG Research of Charleston, LLC-Site Number:8400102, Mt. Pleasant

29812

Rainbow Pediatrics-Site Number:8400074, Barnwell

31210

Meridian Clinical Research-Site Number:8400114, Macon

32607

Sarkis Clinical Trials-Site Number:8400003, Gainesville

33014

Crystal Biomedical Research-Site Number:8400018, Miami Lakes

33174

De Armas Research Center,-Site Number:8400088, Miami

33175

Healthy Life Research-Site Number:8400075, Miami

33186

Acevedo Clinical Research Associates-Site Number:8400032, Miami

33907

Advanced Research for Health Improvement-Site Number:8400096, Fort Myers

35205

Birmingham Pediatric Associates-Site Number:8400049, Birmingham

36305

Southeastern Pediatric Associates-Site Number:8400034, Dothan

37388

Pediatric Clinical Trials Tullahoma-Site Number:8400062, Tullahoma

37620

PMG Research-Bristol-Site Number:8400009, Bristol

37660

Holston Medical Group, Pediatrics at Stone Plaza-Site Number:8400015, Kingsport

39531

MedPharmics Biloxi-Site Number:8400052, Biloxi

40004

Kentucky Pediatics / Adult Research-Site Number:8400044, Bardstown

40202

University of Louisville-Site Number:8400082, Louisville

40207

Brownsboro Park Pediatrics-Site Number:8400040, Louisville

40243

All Children Pediatrics-Site Number:8400069, Louisville

44121

Senders Pediatrics-Site Number:8400061, South Euclid

45414

Ohio Pediatric Research-Site Number:8400064, Dayton

45419

PriMed Clinical Research-Site Number:8400033, Dayton

46544

MOC Research-Site Number:8400095, Mishawaka

63044

Craig Spiegel, MD-Site Number:8400067, Bridgeton

64114

Center for Pharmaceutical Research-Site Number:8400080, Kansas City

68504

Midwest Childrens Health Research Institute-Site Number:8400060, Lincoln

70006

MedPharmics-Site Number:8400048, Metairie

71913

HealthStar Research, LLC-Site Number:8400100, Hot Springs

72401

The Children's Clinic of Jonesboro, PA-Site Number:8400059, Jonesboro

72703

Northwest Arkansas Pediatric Clinic-Site Number:8400042, Fayetteville

73008

The Children's Center Rehabilitation Hospital-Site Number:8400104, Bethany

74127

Oklahoma State University - Center for Health Sciences-Site Number:8400008, Tulsa

76904

Benchmark Research - San Angelo-Site Number:8400011, San Angelo

78229

Southwest Children's Research Associates, P.A.-Site Number:8400002, San Antonio

78413

Crossroads Clinical Research-Site Number:8400058, Corpus Christi

78610

Benchmark Research - Buda-Site Number:8400016, Buda

78726

ARC Clinical Research at Wilson Parke-Site Number:8400071, Austin

80233

IMMUNOe Research Centers - Thornton-Site Number:8400022, Thornton

80922

Optum Clinical Research-Site Number:8400076, Colorado Springs

84015

Tanner Clinic-Site Number:8400079, Clinton

84037

Wee Care Pediatrics-Site Number:8400065, Kaysville

84057

Utah Valley Pediatrics - Timpanogos-Site Number:8400038, Orem

84064

Pediatric Care-Site Number:8400045, Provo

84095

Copperview Medical Center-Site Number:8400068, South Jordan

J Lewis Research Inc-Site Number:8400050, South Jordan

84107

Murray Pediatrics-Site Number:8400019, Murray

84109

J. Lewis Research-Site Number:8400053, Salt Lake City

84121

Foothill Family Research-South-Site Number:8400036, Salt Lake City

85015

MedPharmics, LLC - Phoenix-Site Number:8400043, Phoenix

90240

Premier Health Research Center, LLC-Site Number:8400039, Downey

90723

Center for Clinical Trials, LLC-Site Number:8400056, Paramount

91790

Center for Clinical Trials of San Gabriel-Site Number:8400051, West Covina

Center for Clinical Trials of San Gabriel-Site Number:8400099, West Covina

92220

Advanced Clinical Research - Rancho Paseo-Site Number:8400087, Banning

92804

Emmaus Research Center, Inc-Site Number:8400057, Anaheim

97030

Cyn3rgy Research-Site Number:8400035, Gresham

8400011

Advanced Research for Health Improvement-Site Number:8400005, Naples

32720-0834

Avail Clinical Research, LLC-Site Number:8400055, DeLand

02721

Pediatric Associates of Fall River-Site Number:8400103, Fall River

84075-9645

Alliance for Multispecialty Research Syracuse-Site Number:8400066, Syracuse

54449-5777

Marshfield Clinic-Site Number:8400054, Marshfield

00918

Investigational Site Number :6300014, San Juan

Investigational Site Number :6300108, San Juan

All Listed Sponsors
lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY

NCT03673462 - Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers | Biotech Hunter | Biotech Hunter