A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

PHASE3CompletedINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

October 18, 2018

Primary Completion Date

December 14, 2020

Study Completion Date

December 14, 2020

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

Prevnar 13™

Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.

BIOLOGICAL

V114

V114 contains the 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 given via IM injection.

BIOLOGICAL

RotaTeq™

RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.

BIOLOGICAL

Pentacel™

Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

BIOLOGICAL

RECOMBIVAX HB™

RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

BIOLOGICAL

HIBERIX™

HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.

BIOLOGICAL

M-M-R™ II

M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.

BIOLOGICAL

VARIVAX™

VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.

Trial Locations (34)

10330

Chulalongkorn University ( Site 0092), Bangkok

10700

Siriaj Hospital ( Site 0091), Bangkok

13088

Summerwood Pediatrics ( Site 0009), Liverpool

13202

SUNY Upstate Medical University ( Site 0008), Syracuse

14642

University of Rochester Medical Center ( Site 0029), Rochester

26480

Eskisehir Osmangazi University Faculty of Medicine ( Site 0071), Eskişehir

28625

Piedmont Healthcare, PA ( Site 0025), Statesville

29414

Coastal Pediatric Research ( Site 0006), Charleston

29607

Parkside Pediatric ( Site 0007), Greenville

33184

Suncoast Research Associates, LLC ( Site 0035), Miami

35040

Ege University Medical Faculty Hospital ( Site 0072), Izmir

35205

Alabama Clinical Therapeutics ( Site 0015), Birmingham

36305

Southeastern Pediatric Associates, P.A. ( Site 0002), Dothan

37660

Holston Medical Group ( Site 0018), Kingsport

40002

Srinagarind Hospital. Khon Kaen University ( Site 0093), Muang

40004

Kentucky Pediatric/Adult Research Inc ( Site 0011), Bardstown

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 0090), Chiang Mai

68504

Midwest Children's Health Research Institute, LLC ( Site 0024), Lincoln

68505

Midwest Children's Health Research Institute, LLC ( Site 0003), Lincoln

68516

Midwest Children's Health Research Institute, LLC ( Site 0004), Lincoln

68522

Midwest Children's Health Research Institute, LLC ( Site 0001), Lincoln

72401

Children's Clinic of Jonesboro, PA ( Site 0022), Jonesboro

76104

Ventavia Research Group LLC ( Site 0017), Fort Worth

77555

University of Texas Medical Branch ( Site 0023), Galveston

80922

Davita Medical Group ( Site 0012), Colorado Springs

84107

Wasatch Pediatrics-Cottonwood Office ( Site 0014), Murray

99202

Multicare ( Site 0019), Spokane

02721

Pediatric Associates of Fall River ( Site 0021), Fall River

00961

Cooperativa de Facultad Medica Sanacoop ( Site 0057), Bayamón

00784

Clinical Research of Puerto Rico ( Site 0050), Guayama

00716

CAIMED Center - Ponce School of Medicine ( Site 0053), Ponce

00935

San Juan Hospital ( Site 0056), San Juan

University of Puerto Rico ( Site 0051), San Juan

06230

Hacettepe University Faculty of Medicine ( Site 0070), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03620162 - A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) | Biotech Hunter | Biotech Hunter