A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,080

Participants

Timeline

Start Date

September 23, 2022

Primary Completion Date

June 21, 2023

Study Completion Date

June 21, 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

QIV

Single 0.5 mL IM injection

BIOLOGICAL

Matching Placebo for V116

Single 0.5 mL of sterile saline IM injection

Trial Locations (56)

10017

Synexus Clinical Research US, Inc - New York ( Site 0053), New York

13045

Smith Allergy and Asthma Specialists-Certified Research Associates ( Site 0019), Cortland

13850

Meridian Clinical Research, LLC ( Site 0032), Vestal

14609

Rochester Clinical Research, Inc. ( Site 0055), Rochester

19040

Hatboro Medical Associates / CCT Research ( Site 0065), Hatboro

21075

Centennial Medical Group ( Site 0035), Elkridge

27612

M3 Wake Research Associates ( Site 0040), Raleigh

28303

Carolina Institute for Clinical Research ( Site 0047), Fayetteville

29204

Velocity Clinical Research, Columbia ( Site 0058), Columbia

29621

Velocity Clinical Research, Anderson ( Site 0077), Anderson

30114

East Coast Institute for Research - Canton ( Site 0004), Canton

30281

Clinical Research Atlanta ( Site 0068), Stockbridge

32216

East Coast Institute for Research, LLC ( Site 0013), Jacksonville

32934

Optimal Research ( Site 0008), Melbourne

33009

Velocity Clinical Research, Hallandale Beach ( Site 0064), Hallandale

33012

Indago Research & Health Center, Inc ( Site 0029), Hialeah

33014

Lakes Research ( Site 0063), Miami Lakes

33135

Suncoast Research Group-Clinical Department ( Site 0062), Miami

33173

Suncoast Research Associates ( Site 0041), Miami

33186

Alpha Science Research ( Site 0042), Miami

33407

Triple O Research Institute, P.A ( Site 0054), West Palm Beach

33458

Health Awareness ( Site 0034), Jupiter

37203

Clinical Research Associates Inc ( Site 0026), Nashville

37620

Holston Medical Group-Clinical Research ( Site 0028), Bristol

37660

Holston Medical Group-Clinical Research ( Site 0009), Kingsport

45212

CTI Clinical Research Center ( Site 0071), Cincinnati

60422

Healthcare Research Network - Chicago ( Site 0014), Flossmoor

60602

Synexus Clinical Research US, Inc. ( Site 0072), Chicago

63042

Healthcare Research Network - St. Louis ( Site 0011), St Louis

63141

Radiant Research ( Site 0073), St Louis

68526

Alivation Research-Primary Care ( Site 0066), Lincoln

76135

Benchmark Research ( Site 0025), Fort Worth

77042

New Horizon Medical Group ( Site 0078), Houston

77065

Innovative Medical Research of Texas ( Site 0079), Houston

77584

LinQ Research ( Site 0074), Pearland

78526

Headlands Research - Brownsville ( Site 0069), Brownsville

78705

Optimal Research ( Site 0015), Austin

84095

Alliance for Multispecialty Research, LLC ( Site 0051), South Jordan

84123

Synexus Clinical Research US, Inc. ( Site 0001), Murray

85020

Central Phoenix Medical Clinic-Synexus Clinical Research US ( Site 0012), Phoenix

87505

Axces Research ( Site 0037), Santa Fe

89106

WR-CRCN, LLC ( Site 0018), Las Vegas

91303

Hope Clinical Research, Inc. ( Site 0070), Canoga Park

91325

Valley Clinical Trials, Inc. ( Site 0002), Northridge

91606

Carbon Health - North Hollywood - NoHo West ( Site 0016), North Hollywood

91763

Catalina Research Institute, LLC ( Site 0067), Montclair

91942

Paradigm Clinical Research Centers, Inc ( Site 0024), La Mesa

92103

Artemis Institute for Clinical Research ( Site 0023), San Diego

92120

WR-MCCR, LLC ( Site 0033), San Diego

92123

California Research Foundation ( Site 0005), San Diego

92620

WR- PRI, LLC ( Site 0044), Newport Beach

94598

Diablo Clinical Research, Inc. ( Site 0020), Walnut Creek

97504

Velocity Clinical Research, Medford ( Site 0060), Medford

99204

Arthritis Northwest, PLLC ( Site 0059), Spokane

Velocity Clinical Research, Spokane ( Site 0050), Spokane

02818

Velocity Clinical Research, Providence ( Site 0021), East Greenwich

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY