A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

December 6, 2019

Primary Completion Date

July 12, 2021

Study Completion Date

July 12, 2021

Conditions
Pneumonia, Pneumococcal
Interventions
BIOLOGICAL

V116

Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

BIOLOGICAL

Pneumovax™23

Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Trial Locations (20)

13760

Meridian Clinical Research, LLC ( Site 0025), Endwell

14609

Rochester Clinical Research, Inc. ( Site 0002), Rochester

33012

Indago Research & Health Center, Inc ( Site 0011), Hialeah

33024

Research Centers of America, LLC ( Site 0001), Hollywood

33134

Clinical Research of South Florida ( Site 0008), Coral Gables

33143

QPS Miami Research Associates ( Site 0016), Miami

33144

L&C Professional Medical Research Institute ( Site 0009), Miami

33174

Advanced Medical Research Institute ( Site 0010), Miami

35211

Simon Williamson Clinic ( Site 0004), Birmingham

43537

Advanced Medical Research ( Site 0017), Maumee

45419

PriMED Clinical Research ( Site 0021), Dayton

48098

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018), Troy

61614

Optimal Research ( Site 0006), Peoria

68701

Meridian Clinical Research, LLC ( Site 0024), Norfolk

70006

Benchmark Research ( Site 0012), Metairie

78229

Diagnostics Research Group ( Site 0013), San Antonio

84088

Advanced Clinical Research ( Site 0022), West Jordan

85206

Central Arizona Medical Associates ( Site 0003), Mesa

89104

Wake Research Clinical Research Center of Nevada, LLC ( Site 0014), Las Vegas

97227

Kaiser Permanente Center for Health Research ( Site 0015), Portland

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04168190 - A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001) | Biotech Hunter | Biotech Hunter