NCT03480802 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018) | Biotech Hunter

Enrollment

302

Participants

Timeline

Start Date

July 6, 2018

Primary Completion Date

September 16, 2019

Study Completion Date

January 17, 2020

Conditions

Pneumococcal Infections

Interventions

BIOLOGICAL

V114

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 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) 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, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose

Trial Locations (13)

1862

Chris Hani Baragwanath Hospital ( Site 0122), Johannesburg

7626

Be Part Yoluntu Centre ( Site 0123), Paarl

10700

Siriraj Hosp (Prev&Social Med). ( Site 0183), Bangkok

15001

Via Libre ( Site 0043), Lima

15046

Investigaciones Medicas en Salud - INMENSA ( Site 0041), Lima

32806

Bliss Healthcare Services ( Site 0010), Orlando

33407

Triple O Research Institute, P.A. ( Site 0011), West Palm Beach

50200

Research Institute for Health. ( Site 0182), Chiang Mai

63000

Hopital Gabriel Montpied ( Site 0084), Clemont Ferrand

75475

Hopital Saint Louis ( Site 0094), Paris

75679

Hopital Cochin du Paris ( Site 0089), Paris

77060

Saint Hope Foundation, Inc. ( Site 0009), Houston

77098

The Crofoot Research Center, Inc. ( Site 0002), Houston

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY