Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,484

Participants

Timeline

Start Date

November 7, 2022

Primary Completion Date

October 30, 2023

Study Completion Date

January 30, 2025

Conditions
Pneumococcal Disease
Interventions
BIOLOGICAL

V116

Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

BIOLOGICAL

PPSV23

Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each 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.

Trial Locations (55)

100

National Taiwan University Hospital ( Site 1900), Taipei

333

Chang Gung Medical Foundation-Linkou Branch ( Site 1902), Taoyuan District

704

National Cheng Kung University Hospital ( Site 1901), Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of, Kaohsiung City

1010

Optimal Clinical Trials ( Site 1600), Auckland

2100

Northern Beaches Clinical Research ( Site 1502), Brookvale

2148

Paratus Clinical Research Western Sydney ( Site 1500), Blacktown

4010

Paratus Clinical Research Brisbane ( Site 1501), Albion

4414

P3 Research - Palmerston North ( Site 1602), Palmerston North

5010

P3 Research - Lower Hutt ( Site 1601), Lower Hutt

14584

Soon Chun Hyang University Bucheon Hospital ( Site 1812), Bucheon-si

15355

Korea University Ansan Hospital ( Site 1801), Ansan-si

16247

The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803), Suwon

18450

Hallym University Dongtan Sacred Heart Hospital ( Site 1813), Hwaseong-si

20246

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901), Hamburg

26426

Wonju Severance Christian Hospital ( Site 1808), Wŏnju

28006

Hospital La Princesa-Clinical Pharmacology ( Site 1115), Madrid

28905

Hospital Universitario Getafe ( Site 1111), Getafe

34303

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301), Istanbul

34785

Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305), Sancaktepe

35015

Chungnam national university hospital ( Site 1814), Junggu

41404

Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804), Deagu

45355

Medizentrum Essen Borbeck ( Site 0902), Essen

46015

Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118), Valencia

49201

Dong-A University Hospital ( Site 1810), Busan

50937

Universitaetsklinikum Koeln ( Site 0900), Cologne

60596

InfektioResearch ( Site 0903), Frankfurt am Main

61469

Chonnam National University Hospital-Infectious Diseases ( Site 1811), Gwangju

80020

IPS Centro Científico Asistencial S.A.S ( Site 0407), Barranquilla

81675

klinikum rechts der isar der technischen universität münchen ( Site 0904), München

760032

Fundacion Valle del Lili- CIC ( Site 0415), Santiago de Cali

3081000

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001), Sakhnin

3109601

Rambam Health Care Campus ( Site 1002), Haifa

4428164

Meir Medical Center-Infectious unit ( Site 1003), Kfar Saba

5265601

Sheba Medical Center ( Site 1000), Ramat Gan

9112001

Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004), Jerusalem

S2000DEJ

Fundacion Estudios Clinicos ( Site 0200), Rosario

03312

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802), Seoul

05505

Asan Medical Center ( Site 1809), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806), Seoul

07441

Hallym University Kangnam Sacred Heart Hospital ( Site 1807), Seoul

07985

Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805), Seoul

08308

Korea University Guro Hospital ( Site 1800), Seoul

08500

EBA CENTELLES ( Site 1100), Centelles

08023

Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101), Barcelona

08025

EAP Sardenya ( Site 1102), Barcelona

06230

ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304), Ankara

Hacettepe Universite Hastaneleri-İnfection ( Site 1300), Ankara

06560

Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site, Ankara

BD18 3SA

Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405), Shipley

EC1M 6BQ

Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407), London

NW32QG

Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402), London

FY3 7EN

Layton Medical Centre ( Site 1400), Blackpool

NN18 9EZ

Accellacare - Northamptonshire ( Site 1403), Corby

CV3 4FJ

Accellacare - Warwickshire ( Site 1404), Coventry

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY