A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

PHASE3CompletedINTERVENTIONAL
Enrollment

717

Participants

Timeline

Start Date

July 12, 2022

Primary Completion Date

May 16, 2023

Study Completion Date

May 16, 2023

Conditions
Pneumonia, Pneumococcal
Interventions
BIOLOGICAL

V116

Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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

PCV15

Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension

BIOLOGICAL

PPSV23

Pneumococcal 23-valent vaccine with 25 μg of each of the 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 (51)

100

National Taiwan University Hospital ( Site 0800), Taipei

704

National Cheng Kung University Hospital ( Site 0801), Tainan City

15355

Korea University Ansan Hospital ( Site 0751), Ansan-si

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400), Milan

20132

Ospedale San Raffaele ( Site 0403), Milan

21075

Centennial Medical Group ( Site 0002), Elkridge

21565

Gachon University Gil Medical Center ( Site 0755), Namdong-gu

23606

Health Research of Hampton Roads, Inc. ( Site 0003), Newport News

28006

Hospital La Princesa ( Site 0515), Madrid

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508), Pozuelo de Alarcón

29609

CHRU de Brest ( Site 0200), Brest

29630

Hospital Internacional Xanit ( Site 0520), Benalmádena

33012

Indago Research & Health Center, Inc ( Site 0005), Hialeah

33134

Alliance for Multispecialty Research, LLC ( Site 0020), Coral Gables

33174

Advanced Medical Research Institute ( Site 0018), Miami

33600

CHU Bordeaux Haut-Leveque ( Site 0202), Pessac

35205

Central Research Associates ( Site 0024), Birmingham

43537

Advanced Medical Research ( Site 0001), Maumee

48098

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016), Troy

68701

Meridian Clinical Research, LLC ( Site 0009), Norfolk

69310

centre hospitalier lyon sud ( Site 0204), Pierre-Bénite

71100

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405), Foggia

71713

Maccabi Healthcare Services ( Site 0306), Jerusalem

75679

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203), Paris

77555

University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si, Galveston

83646

Solaris Clinical Research ( Site 0025), Meridian

85283

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006), Tempe

85308

Lenzmeier Family Medicine/CCT Research ( Site 0008), Glendale

90127

A.O.U. Policlinico Paolo Giaccone ( Site 0402), Palermo

92708

Southland Clinical Research Center ( Site 0026), Fountain Valley

94598

Diablo Clinical Research, Inc. ( Site 0019), Walnut Creek

3081000

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302), Sakhnin

3109601

Rambam Health Care Campus ( Site 0303), Haifa

4428164

Meir Medical Center ( Site 0301), Kfar Saba

5265601

Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304), Ramat Gan

9112001

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300), Jerusalem

L8M 1K7

Hamilton Medical Research Group ( Site 0114), Hamilton

N5W 6A2

Milestone Research Inc. ( Site 0104), London

J7J 2K8

Manna Research Mirabel ( Site 0109), Mirabel

G1E 7G9

CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120), Québec

J1L 0H8

Diex Recherche Sherbrooke Inc. ( Site 0101), Sherbrooke

Unknown

Maccabi Health Services - Holon ( Site 0305), Holon

Korea University Guro Hospital ( Site 0750), Seoul

812-0025

PS Clinic ( Site 0700), Fukuoka

861-4157

Nishikumamoto Hospital ( Site 0701), Kumamoto

03312

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753), Seoul

07441

Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754), Seoul

08036

HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503), Barcelona

08500

EBA CENTELLES ( Site 0500), Centelles

08907

Hospital Universitari de Bellvitge ( Site 0505), L'Hospitalet de Llobregat

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY