Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,720

Participants

Timeline

Start Date

June 19, 2019

Primary Completion Date

May 24, 2021

Study Completion Date

May 24, 2021

Conditions
Pneumococcal InfectionsPneumococcal Vaccines
Interventions
BIOLOGICAL

V114

V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.

BIOLOGICAL

Prevnar 13™

Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.

BIOLOGICAL

RotaTeq™

A total of 3 RotaTeq™ 2 mL oral dosings at \~2, \~4, and \~6 months of age.

BIOLOGICAL

Pentacel™

A total of 3 Pentacel™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.

BIOLOGICAL

RECOMBIVAX HB™

A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \~2, \~4, and \~6 months of age.

BIOLOGICAL

VAQTA™

One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.

BIOLOGICAL

MMR II™

One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.

BIOLOGICAL

VARIVAX™

One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.

BIOLOGICAL

HIBERIX™

One HIBERIX™ 0.5 mL IM dosing at Visit 5.

Trial Locations (81)

10400

Phramongkutklao Hospital ( Site 0033), Bangkok

10468

Advantage Clinical Trials ( Site 0274), The Bronx

10700

Siriraj Hospital ( Site 0032), Bangkok

13057

Child Health Care Associates ( Site 0242), East Syracuse

13090

Child Health Care Associates ( Site 0267), Liverpool

16148

CCP- Kid's Way ( Site 0130), Hermitage

16506

Allegheny Health & Wellness Pavilion West ( Site 0210), Erie

19034

Lockman & Lubell Pediatrics ( Site 0166), Fort Washington

19401

Pediatric Medical Associates ( Site 0239), East Norriton

20910

Virgo-Carter Pediatrics ( Site 0275), Silver Spring

27609

Capitol Pediatrics & Adolescent Center ( Site 0223), Raleigh

28721

Haywood Pediatric and Adolescent Medicine Group ( Site 0248), Clyde

29520

Cheraw Pediatrics ( Site 0280), Cheraw

29607

Parkside Pediatric ( Site 0125), Greenville

33160

Suncoast Research Associates, LLC ( Site 0249), North Miami Beach

33184

Suncoast Research Associates, LLC ( Site 0250), Miami

33617

Children's Health Center ( Site 0272), Tampa

35040

Ege University Medical Faculty Hospital ( Site 0050), Izmir

35205

Alabama Clinical Therapeutics ( Site 0159), Birmingham

35340

Dokuz Eylul University Faculty of Medicine ( Site 0054), Izmir

36305

Southeastern Pediatric Associates, P.A. ( Site 0107), Dothan

36467

South Alabama Pediatrics ( Site 0263), Opp

37660

Holston Medical Group ( Site 0165), Kingsport

38039

Erciyes Universitesi Tip Fakultesi ( Site 0057), Kayseri

39465

MediSync Clinical Research Hattiesburg Clinic ( Site 0259), Petal

40002

Khon Kaen University ( Site 0031), Muang

40004

Kentucky Pediatric/Adult Research Inc ( Site 0136), Bardstown

40356

Michael W Simon, MD., Pediatric & Adolescent Medicine ( Site 0276), Nicholasville

44121

Senders Pediatrics ( Site 0190), Cleveland

45406

Dayton Clinical Research ( Site 0188), Dayton

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 0030), Chiang Mai

64111

Children's Mercy Clinics on Broadway ( Site 0171), Kansas City

68198

Children's Physicians, UNMC ( Site 0252), Omaha

68505

Midwest Children's Health Research Institute, LLC ( Site 0109), Lincoln

68522

Midwest Children's Health Research Institute, LLC ( Site 0106), Lincoln

70006

Medpharmics, LLC ( Site 0157), Metairie

71037

ACC Pediatric Research ( Site 0147), Haughton

72401

Children's Clinic of Jonesboro, PA ( Site 0184), Jonesboro

72703

Northwest Arkansas Pediatric Clinic ( Site 0172), Fayetteville

75234

DFW Clinical Research ( Site 0111), Dallas

75605

DCOL Center for Clinical Research ( Site 0247), Longview

76248

Ventavia Research Group LLC ( Site 0139), Keller

76550

FMC Science ( Site 0115), Lampasas

77008

Ventavia Research Group LLC ( Site 0142), Houston

77087

Pediatric Associates ( Site 0209), Houston

77090

Houston Clinical Research Network ( Site 0266), Houston

77555

University of Texas Medical Branch ( Site 0185), Galveston

77573

University of Texas Medical Branch ( Site 0170), League City

80922

Davita Medical Group ( Site 0141), Colorado Springs

83686

Saltzer Medical Group ( Site 0215), Nampa

84041

Wee Care Pediatrics ( Site 0154), Layton

84067

Wee Care Pediatrics-Roy ( Site 0174), Roy

84075

Wee Care Pediatrics ( Site 0193), Syracuse

84107

Cottonwood Pediatrics ( Site 0153), Murray

84113

University of Utah ( Site 0214), Salt Lake City

84604

Pediatric Care ( Site 0138), Provo

84790

Dixie Pediatrics ( Site 0260), St. George

87501

Southwest CARE Center ( Site 0161), Santa Fe

90240

Premier Health Research Center, LLC ( Site 0121), Downey

90706

Altissima Clinical Research LLC ( Site 0213), Bellflower

Southland Clinical Research Center ( Site 0187), Bellflower

92220

Advanced Clinical Research - Rancho Paseo ( Site 0163), Banning

94612

Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282), Oakland

95051

Kaiser Permanente - Santa Clara ( Site 0244), Santa Clara

95119

Kaiser Permanente - San Jose ( Site 0258), San Jose

95815

Kaiser Permanente - Sacramento ( Site 0257), Sacramento

95823

Kaiser Permanente Vaccine Study Center - South Sacramento ( Site 0256), Sacramento

97030

Cyn3rgy Research ( Site 0246), Gresham

99004

MultiCare Rockwood Cheney Clinic ( Site 0195), Cheney

99202

Multicare / Rockwood Clinic ( Site 0167), Spokane

02111

Tufts Medical Center-Floating Hospital for Children ( Site 0129), Boston

02721

Pediatric Associates of Fall River ( Site 0183), Fall River

29406-9170

Palmetto Pediatrics, PA ( Site 0164), Charleston

00961

Cooperativa de Facultad Medica Sanacoop ( Site 0077), Bayamón

00784

Clinical Research of Puerto Rico ( Site 0075), Guayama

00716

CAIMED Center - Ponce School of Medicine ( Site 0076), Ponce

00935

San Juan Hospital ( Site 0079), San Juan

University of Puerto Rico - Medical Science Campus ( Site 0078), San Juan

00976

Elba Antoniette Perez Vargas MD-Private Practice ( Site 0081), Trujillo Alto

01330

Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0060), Adana

06590

Ankara Universitesi Tip Fakultesi ( Site 0053), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03893448 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) | Biotech Hunter | Biotech Hunter