A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)

PHASE2CompletedINTERVENTIONAL
Enrollment

1,051

Participants

Timeline

Start Date

March 21, 2017

Primary Completion Date

October 4, 2018

Study Completion Date

October 4, 2018

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114 Lot 1

Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

BIOLOGICAL

V114 Lot 2

Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose

BIOLOGICAL

Prevnar 13™

Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose

Trial Locations (49)

13057

Child Health Care Associates ( Site 0064), East Syracuse

13210

State University of New York Upstate Medical University ( Site 0065), Syracuse

16148

Kid's Way Pediatrics ( Site 0036), Hermitage

19107

Thomas Jefferson University ( Site 0067), Philadelphia

19401

Pediatric Medical Associates ( Site 0059), East Norriton

22902

Pediatric Research of Charlottesville, LLC ( Site 0066), Charlottesville

23113

Huguenot Pediatrics ( Site 0057), Midlothian

29414

Coastal Pediatric Research ( Site 0070), Charleston

35205

Birmingham Pediatric Research ( Site 0043), Birmingham

36305

Southeastern Pediatric Associates, P.A. ( Site 0079), Dothan

37660

Holston Medical Group [Kingsport, TN] ( Site 0048), Kingsport

40004

Kentucky Pediatric/Adult Research Inc ( Site 0037), Bardstown

40202

University of Louisville: Pediatric Clinical Trials Unit ( Site 0049), Louisville

44121

Senders Pediatrics ( Site 0058), Cleveland

45245

Pediatric Associates of Mt. Carmel, Inc. ( Site 0052), Cincinnati

45414

Ohio Pediatric Research Association ( Site 0060), Dayton

68132

Dundee Clinic ( Site 0063), Omaha

71037

ACC Pediatric Research ( Site 0039), Haughton

72401

Children's Clinic of Jonesboro, PA ( Site 0054), Jonesboro

77555

University of Texas Medical Branch at Galveston ( Site 0056), Galveston

77573

University of Texas Medical Branch at Galveston ( Site 0068), League City

84041

Wee Care Pediatrics ( Site 0042), Layton

84095

Copperview Medical Center ( Site 0062), South Jordan

84107

Cottonwood Pediatrics ( Site 0041), Murray

90241

Premier Health Research Center, LLC ( Site 0035), Downey

93550

Sherif Khamis MD, Inc. ( Site 0044), Palmdale

95661

Kaiser Permanente - Roseville ( Site 0045), Roseville

95815

Kaiser Permanente Clinical Trial - Sacramento ( Site 0076), Sacramento

98926

Family Health Care of Ellensburg ( Site 0077), Ellensburg

01801

Woburn Pediatric Associates ( Site 0046), Woburn

H9H 4M7

CHU Ste-Justine ( Site 0084), Montreal

McGill University Health Centre - Vaccine Study Centre ( Site 0030), Pierrefonds

CHU de Quebec Universite de Laval ( Site 0031), Québec

Unknown

Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025), Aarhus N

OUH Klinisk Forsk center Gyn Obs D. ( Site 0024), Odense

Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007), Espoo

Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005), Helsinki

Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006), Helsinki

Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003), Järvenpää

Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004), Oulu

Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008), Pori

Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001), Tampere

Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002), Turku

Soroka University Medical Center ( Site 0019), Beersheba

Soroka University Medical Center - Rahat Family health center ( Site 0020), Beersheba

Soroka University Medical Center - Ramot Family health center ( Site 0021), Beersheba

Soroka University Medical Center - Vav Family health center ( Site 0022), Beersheba

Hospital Clinico Universitario de Santiago ( Site 0016), Santiago de Compostela

Unidad de Estudios e Investigacion IHP ( Site 0017), Seville

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02987972 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008) | Biotech Hunter | Biotech Hunter