NCT03480763 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Healthy Adults 50 Years of Age or Older (V114-016/PNEU-PATH) | Biotech Hunter

Enrollment

652

Participants

Timeline

Start Date

June 22, 2018

Primary Completion Date

December 23, 2019

Study Completion Date

December 23, 2019

Conditions

Pneumococcal Infections

Interventions

BIOLOGICAL

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose

BIOLOGICAL

Prevnar 13™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose

BIOLOGICAL

PNEUMOVAX™23

23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Trial Locations (22)

100

National Taiwan University Hospital ( Site 0500), Taipei

21075

Centennial Medical Group ( Site 0109), Elkridge

23606

Health Research of Hampton Roads, Inc. ( Site 0106), Newport News

33134

Clinical Research of South Florida ( Site 0126), Coral Gables

33143

QPS Miami Research Associates ( Site 0116), South Miami

44122

Rapid Medical Research, Inc. ( Site 0119), Cleveland

46015

Fundacion Oftalmologica del Mediterraneo ( Site 0300), Valencia

67207

Heartland Research Associates, Llc ( Site 0115), Wichita

70403

National Cheng Kung University Hospital ( Site 0502), Dawan

77081

Texas Center For Drug Development ( Site 0107), Houston

78229

Diagnostics Research Group ( Site 0100), San Antonio

84095

J Lewis Research Inc/Jordan River Family Medicine ( Site 0114), South Jordan

84109

J Lewis Research Inc / Foothill Family Clinic ( Site 0123), Salt Lake City

85020

Central Phoenix Medical Clinic, LLC ( Site 0125), Phoenix

85224

East Valley Family Physicians ( Site 0104), Chandler

91978

Encompass Clinical Research ( Site 0118), Spring Valley

94598

Diablo Clinical Research, Inc ( Site 0132), Walnut Creek

77555-1115

University of Texas Medical Branch at Galveston ( Site 0127), Galveston

03080

Seoul National University Hospital ( Site 0400), Seoul

08308

Korea University Guro Hospital ( Site 0401), Seoul

08540

CAP Centelles ( Site 0303), Centelles

03004

Instituto de Ciencias Medicas.ICM ( Site 0301), Alicante

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY