Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,663

Participants

Timeline

Start Date

July 13, 2022

Primary Completion Date

May 18, 2023

Study Completion Date

May 18, 2023

Conditions
Pneumococcal Infection
Interventions
BIOLOGICAL

V116

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

BIOLOGICAL

PCV20

0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

Trial Locations (112)

110

Taipei Medical University Hospital ( Site 3302), Taipei

333

Chang Gung Medical Foundation-Linkou Branch ( Site 3303), Taoyuan District

704

National Cheng Kung University Hospital ( Site 3301), Tainan City

2019

Emeritus Research ( Site 3004), Botany

2145

Westmead Hospital ( Site 3005), Westmead

2259

Paratus Clinical Research Central Coast ( Site 3001), Kanwal

2617

Paratus Clinical Research Canberra ( Site 3000), Bruce

3010

Lakeland Clinical Trials ( Site 3102), Rotorua

3110

P3 Research - Tauranga ( Site 3100), Tauranga

3124

Emeritus Research ( Site 3003), Camberwell

3590

Anima Diepenbeek ( Site 1003), Diepenbeek

5101

Private Practice - Dr. Martinot Jean-Benoit ( Site 1001), Erpent

6021

P3 Research - Wellington ( Site 3101), Wellington

8013

Southern Clinical Trials Ltd ( Site 3104), Christchurch

10002

National Taiwan University Hospital ( Site 3300), Taipei

10117

Novopraxis Berlin GbR ( Site 1201), Berlin

14845

Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032), Horseheads

15355

Korea University Ansan Hospital ( Site 3201), Ansan-si

16247

The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206), Suwon

16499

Ajou University Hospital-Department of Infectious Diseases ( Site 3209), Suwon

20246

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202), Hamburg

20354

Hamburger Institut fuer Therapieforschung GmbH ( Site 1204), Hamburg

21565

Gachon University Gil Medical Center ( Site 3205), Namdong-gu

22911

Charlottesville Medical Research ( Site 0034), Charlottesville

23606

Health Research of Hampton Roads, Inc. ( Site 0004), Newport News

29572

Trial Management Associates ( Site 0089), Myrtle Beach

29615

Velocity Clinical Research, Greenville ( Site 0043), Greenville

32055

East Coast Institute for Research ( Site 0071), Lake City

32204

East Coast Institute for Research, LLC ( Site 0070), Jacksonville

32720

Hillcrest Medical Research ( Site 0049), DeLand

32819

Headlands Research Orlando ( Site 0031), Orlando

33134

Alliance for Multispecialty Research, LLC ( Site 0015), Coral Gables

33144

L&C Professional Medical Research Institute ( Site 0025), Miami

33174

Advanced Medical Research Institute ( Site 0014), Miami

33409

Palm Beach Research Center ( Site 0060), West Palm Beach

33462

JEM Research Institute ( Site 0072), Atlantis

33603

Genesis Clinical Research, LLC ( Site 0016), Tampa

33607

Clinical Research Trials of Florida ( Site 0007), Tampa

34303

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201), Istanbul

35205

Central Research Associates ( Site 0067), Birmingham

40383

Versailles Family Medicine / CCT Research ( Site 0063), Versailles

41404

Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207), Deagu

43213

Aventiv Research Inc ( Site 0044), Columbus

43537

Advanced Medical Research ( Site 0002), Maumee

45355

Medizentrum Essen Borbeck ( Site 1200), Essen

48098

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038), Troy

50937

Universitaetsklinikum Koeln ( Site 1206), Cologne

54100

Sakarya Training and Research Hospital ( Site 2205), Adapazarı

60596

InfektioResearch ( Site 1203), Frankfurt am Main

64114

Alliance for Multispecialty Research, LLC ( Site 0026), Kansas City

68022

Skyline Medical Center/CCT Research ( Site 0028), Elkhorn

68025

Methodist Physicians Clinic/CCT Research ( Site 0058), Fremont

68701

Meridian Clinical Research, LLC ( Site 0045), Norfolk

72205

Baptist Health Center For Clinical Research ( Site 0019), Little Rock

73072

Lynn Institute of Norman ( Site 0001), Norman

73112

Lynn Health Science Institute ( Site 0005), Oklahoma City

74135

Lynn Institute of Tulsa ( Site 0084), Tulsa

75067

Epic Clinical Research ( Site 0082), Lewisville

75093

Research Your Health ( Site 0042), Plano

75224

WR-Global Medical Research, LLC ( Site 0065), Dallas

75605

DCOL Center for Clinical Research ( Site 0051), Longview

77077

Elixir Research Group - W Houston ( Site 0068), Houston

77375

Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036), Tomball

78229

IMA Clinical Research San Antonio ( Site 0009), San Antonio

78230

VIP Trials ( Site 0086), San Antonio

78745

Tekton Research, Inc. ( Site 0053), Austin

80012

Lynn Institute of Denver ( Site 0012), Aurora

80033

Paradigm Clinical Research Centers, Inc ( Site 0027), Wheat Ridge

83404

Clinical Research Prime ( Site 0010), Idaho Falls

83646

Solaris Clinical Research ( Site 0008), Meridian

84117

Olympus Family Medicine/CCT Research ( Site 0074), Holladay

84405

South Ogden Family Medicine/ CCT Research ( Site 0022), Ogden

85044

Foothills Research Center/ CCT Research ( Site 0021), Phoenix

85213

Desert Clinical Research/ CCT Research ( Site 0040), Mesa

85283

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003), Tempe

85308

Lenzmeier Family Medicine/CCT Research ( Site 0006), Glendale

89102

Healor Primary Care / CCT Research ( Site 0056), Las Vegas

89109

Excel Clinical Research, LLC ( Site 0077), Las Vegas

89119

Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029), Las Vegas

90274

Peninsula Research Associates ( Site 0079), Rolling Hills Estates

92120

Acclaim Clinical Research ( Site 0083), San Diego

92708

Southland Clinical Research Center-Research ( Site 0054), Fountain Valley

93065

Millennium Clinical Trials ( Site 0013), Simi Valley

93534

Chemidox Clinical Trials ( Site 0048), Lancaster

94549

Sunwise Clinical Research ( Site 0024), Lafayette

96001

Paradigm Clinical Research Centers, Inc ( Site 0018), Redding

97210

Summit Headlands ( Site 0047), Portland

99204

MultiCare Rockwood Cheney Clinic ( Site 0037), Spokane

4781151

Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504), Temuco

7500000

Universidad San Sebastian - Providencia ( Site 0514), Providencia

7770086

Espacio Eme ( Site 0509), Santiago

8330034

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503), Santiago

0626

Southern Clinical Trials Waitemata Ltd ( Site 3105), Auckland

00961

Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601), Bayamón

00725

San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606), Caguas

00729

Clinical Research Investigator Group ( Site 0611), Canovanas

00716

Ponce School Of Medicine Caimed Center ( Site 0602), Ponce

00909

Clinical Research Puerto Rico ( Site 0600), San Juan

03312

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202), Seoul

03722

Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210), Seoul

06351

Samsung Medical Center ( Site 3211), Seoul

06591

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203), Seoul

07441

Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204), Seoul

Unknown

Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208), Seoul

Korea University Guro Hospital ( Site 3200), Seoul

222 22

ProbarE ( Site 1400), Lund

171 64

CTC Karolinska ( Site 1405), Solna

113 29

ProbarE i Stockholm AB ( Site 1401), Stockholm

113 61

Studieenheten Akademiskt Specialistcentrum ( Site 1403), Stockholm

752 37

CTC MTC ( Site 1404), Uppsala

06230

Hacettepe Universite Hastaneleri ( Site 2204), Ankara

06800

Ankara City Hospital ( Site 2200), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY