A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

PHASE3CompletedINTERVENTIONAL
Enrollment

2,162

Participants

Timeline

Start Date

August 12, 2022

Primary Completion Date

May 25, 2023

Study Completion Date

May 25, 2023

Conditions
Pneumococcal Disease
Interventions
BIOLOGICAL

V116

Pneumococcal 21-valent conjugate vaccine with 4 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

PPSV23

Pneumococcal 23-valent conjugate 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 (72)

1060

Tropeninstitut Wien 1060 ( Site 0300), Vienna

1090

Medizinische Universität Wien ( Site 0302), Vienna

2730

Sanos Clinic-Sanos Clinic ( Site 0402), Herlev

2860

Danske Lægers Vaccinations Service - Søborg ( Site 0404), Søborg

6020

Medizinische Universitaet Innsbruck ( Site 0301), Innsbruck

7100

Sanos Clinic - Syddanmark ( Site 0400), Vejle

8000

Danske Lægers Vaccinations Service - Århus ( Site 0403), Aarhus

8036

Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304), Graz

9362

Sanos Clinic - Nordjylland ( Site 0401), Aalborg

14609

Rochester Clinical Research, Inc. ( Site 0033), Rochester

20520

FVR, Turun rokotetutkimusklinikka ( Site 0500), Turku

22911

Charlottesville Medical Research ( Site 0013), Charlottesville

23606

Health Research of Hampton Roads, Inc. ( Site 0002), Newport News

27612

M3 Wake Research Associates ( Site 0035), Raleigh

28006

Hospital La Princesa-Clinical Pharmacology ( Site 0815), Madrid

28100

FVR, Porin rokotetutkimusklinikka ( Site 0508), Pori

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808), Pozuelo de Alarcón

29615

Velocity Clinical Research, Greenville ( Site 0021), Greenville

32819

Headlands Research Orlando ( Site 0017), Orlando

33012

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

33144

L&C Professional Medical Research Institute ( Site 0012), Miami

33607

Clinical Research Trials of Florida ( Site 0001), Tampa

37203

Clinical Research Associates Inc ( Site 0039), Nashville

40004

Kentucky Pediatric/ Adult Research ( Site 0036), Bardstown

46015

Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818), Valencia

60100

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504), Seinäjoki

60422

Healthcare Research Network - Chicago ( Site 0006), Flossmoor

64114

Alliance for Multispecialty Research, LLC ( Site 0031), Kansas City

68025

Methodist Physicians Clinic/CCT Research ( Site 0029), Fremont

71713

Maccabi Healthcare Services ( Site 0606), Jerusalem

72205

Baptist Health Center For Clinical Research ( Site 0015), Little Rock

73112

Lynn Health Science Institute ( Site 0014), Oklahoma City

75605

DCOL Center for Clinical Research ( Site 0025), Longview

77375

Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016), Tomball

78229

IMA Clinical Research San Antonio ( Site 0020), San Antonio

80012

Lynn Institute of Denver ( Site 0003), Aurora

83440

Clinical Research Prime Rexburg ( Site 0040), Rexburg

85213

Desert Clinical Research/ CCT Research ( Site 0019), Mesa

85283

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008), Tempe

87505

Axces Research ( Site 0034), Santa Fe

89102

Healor Primary Care / CCT Research ( Site 0028), Las Vegas

90220

FVR, Oulun rokotetutkimusklinikka ( Site 0501), Oulu

91325

Valley Clinical Trials, Inc. ( Site 0023), Northridge

92103

Artemis Institute for Clinical Research ( Site 0027), San Diego

93065

Millennium Clinical Trials ( Site 0004), Simi Valley

94598

Diablo Clinical Research, Inc. ( Site 0022), Walnut Creek

3081000

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602), Sakhnin

3109601

Rambam Health Care Campus ( Site 0603), Haifa

4428164

Meir Medical Center ( Site 0601), Kfar Saba

5265601

Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604), Ramat Gan

9112001

Hadassah Medical Center ( Site 0600), Jerusalem

02818

Velocity Clinical Research, Providence ( Site 0018), East Greenwich

B2N 1L2

Colchester Research Group ( Site 0202), Truro

L8M 1K7

Hamilton Medical Research Group ( Site 0208), Hamilton

N5W 6A2

Milestone Research Inc. ( Site 0201), London

M9W 4L6

Manna Research Toronto ( Site 0209), Toronto

J7J 2K8

Manna Research Mirabel ( Site 0207), Mirabel

H9R 4S3

Manna Research Montreal ( Site 0203), Pointe-Claire

J1J 2G2

Q&T Research Sherbrooke Inc. ( Site 0204), Sherbrooke

G9A 4P3

Diex Recherche Trois-Rivieres ( Site 0206), Trois-Rivières

02230

FVR, Espoon rokotetutkimusklinikka ( Site 0509), Espoo

00100

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503), Helsinki

00930

Helsinki East Vaccine Research Clinic ( Site 0502), Helsinki

85-048

IN VIVO ( Site 0711), Bydgoszcz

85-796

Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709), Bydgoszcz

87-100

MICS Centrum Medyczne Torun ( Site 0706), Torun

20-095

Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703), Lublin

35-055

Centrum Medyczne Medyk ( Site 0704), Rzeszów

96-100

Clinmedica OMC ( Site 0701), Skierniewice

08500

EBA CENTELLES ( Site 0800), Centelles

08023

Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801), Barcelona

08025

EAP Sardenya ( Site 0802), Barcelona

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY