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

NCT ID: NCT05425732

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2663 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2023-05-18

Brief Summary

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

Conditions

Pneumococcal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1 V116

Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.

Group Type: EXPERIMENTAL

V116

Intervention Type: BIOLOGICAL

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.

Cohort 1 PCV20

Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.

Group Type: ACTIVE_COMPARATOR

PCV20

Intervention Type: BIOLOGICAL

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.

Cohort 2 V116

Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

Group Type: EXPERIMENTAL

V116

Intervention Type: BIOLOGICAL

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.

Cohort 2 PCV20

Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.

Group Type: ACTIVE_COMPARATOR

PCV20

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal 21-valent Conjugate Vaccine; Prevnar 20™; APEXXNAR™

Eligibility Criteria

Inclusion Criteria

• For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.

Exclusion Criteria

• Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
• Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid
• Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating IM vaccination
• Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
• Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
• Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
• Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
• Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
• Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
• Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
• Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Central Research Associates ( Site 0067)

Birmingham, Alabama, United States

Lenzmeier Family Medicine/CCT Research ( Site 0006)

Glendale, Arizona, United States

Desert Clinical Research/ CCT Research ( Site 0040)

Mesa, Arizona, United States

Foothills Research Center/ CCT Research ( Site 0021)

Phoenix, Arizona, United States

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

Tempe, Arizona, United States

Baptist Health Center For Clinical Research ( Site 0019)

Little Rock, Arkansas, United States

Southland Clinical Research Center-Research ( Site 0054)

Fountain Valley, California, United States

Sunwise Clinical Research ( Site 0024)

Lafayette, California, United States

Chemidox Clinical Trials ( Site 0048)

Lancaster, California, United States

Paradigm Clinical Research Centers, Inc ( Site 0018)

Redding, California, United States

Peninsula Research Associates ( Site 0079)

Rolling Hills Estates, California, United States

Acclaim Clinical Research ( Site 0083)

San Diego, California, United States

Millennium Clinical Trials ( Site 0013)

Simi Valley, California, United States

Lynn Institute of Denver ( Site 0012)

Aurora, Colorado, United States

Paradigm Clinical Research Centers, Inc ( Site 0027)

Wheat Ridge, Colorado, United States

JEM Research Institute ( Site 0072)

Atlantis, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0015)

Coral Gables, Florida, United States

Hillcrest Medical Research ( Site 0049)

DeLand, Florida, United States

East Coast Institute for Research, LLC ( Site 0070)

Jacksonville, Florida, United States

East Coast Institute for Research ( Site 0071)

Lake City, Florida, United States

L&C Professional Medical Research Institute ( Site 0025)

Miami, Florida, United States

Advanced Medical Research Institute ( Site 0014)

Miami, Florida, United States

Headlands Research Orlando ( Site 0031)

Orlando, Florida, United States

Genesis Clinical Research, LLC ( Site 0016)

Tampa, Florida, United States

Clinical Research Trials of Florida ( Site 0007)

Tampa, Florida, United States

Palm Beach Research Center ( Site 0060)

West Palm Beach, Florida, United States

Clinical Research Prime ( Site 0010)

Idaho Falls, Idaho, United States

Solaris Clinical Research ( Site 0008)

Meridian, Idaho, United States

Versailles Family Medicine / CCT Research ( Site 0063)

Versailles, Kentucky, United States

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

Troy, Michigan, United States

Alliance for Multispecialty Research, LLC ( Site 0026)

Kansas City, Missouri, United States

Skyline Medical Center/CCT Research ( Site 0028)

Elkhorn, Nebraska, United States

Methodist Physicians Clinic/CCT Research ( Site 0058)

Fremont, Nebraska, United States

Meridian Clinical Research, LLC ( Site 0045)

Norfolk, Nebraska, United States

Healor Primary Care / CCT Research ( Site 0056)

Las Vegas, Nevada, United States

Excel Clinical Research, LLC ( Site 0077)

Las Vegas, Nevada, United States

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

Las Vegas, Nevada, United States

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

Horseheads, New York, United States

Aventiv Research Inc ( Site 0044)

Columbus, Ohio, United States

Advanced Medical Research ( Site 0002)

Maumee, Ohio, United States

Lynn Institute of Norman ( Site 0001)

Norman, Oklahoma, United States

Lynn Health Science Institute ( Site 0005)

Oklahoma City, Oklahoma, United States

Lynn Institute of Tulsa ( Site 0084)

Tulsa, Oklahoma, United States

Summit Headlands ( Site 0047)

Portland, Oregon, United States

Velocity Clinical Research, Greenville ( Site 0043)

Greenville, South Carolina, United States

Trial Management Associates ( Site 0089)

Myrtle Beach, South Carolina, United States

Tekton Research, Inc. ( Site 0053)

Austin, Texas, United States

WR-Global Medical Research, LLC ( Site 0065)

Dallas, Texas, United States

Elixir Research Group - W Houston ( Site 0068)

Houston, Texas, United States

Epic Clinical Research ( Site 0082)

Lewisville, Texas, United States

DCOL Center for Clinical Research ( Site 0051)

Longview, Texas, United States

Research Your Health ( Site 0042)

Plano, Texas, United States

IMA Clinical Research San Antonio ( Site 0009)

San Antonio, Texas, United States

VIP Trials ( Site 0086)

San Antonio, Texas, United States

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

Tomball, Texas, United States

Olympus Family Medicine/CCT Research ( Site 0074)

Holladay, Utah, United States

South Ogden Family Medicine/ CCT Research ( Site 0022)

Ogden, Utah, United States

Charlottesville Medical Research ( Site 0034)

Charlottesville, Virginia, United States

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

Newport News, Virginia, United States

MultiCare Rockwood Cheney Clinic ( Site 0037)

Spokane, Washington, United States

Paratus Clinical Research Canberra ( Site 3000)

Bruce, Australian Capital Territory, Australia

Emeritus Research ( Site 3004)

Botany, New South Wales, Australia

Paratus Clinical Research Central Coast ( Site 3001)

Kanwal, New South Wales, Australia

Westmead Hospital ( Site 3005)

Westmead, New South Wales, Australia

Emeritus Research ( Site 3003)

Camberwell, Victoria, Australia

Anima Diepenbeek ( Site 1003)

Diepenbeek, Limburg, Belgium

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

Erpent, Namur, Belgium

Universidad San Sebastian - Providencia ( Site 0514)

Providencia, Region M. de Santiago, Chile

Espacio Eme ( Site 0509)

Santiago, Region M. de Santiago, Chile

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)

Santiago, Region M. de Santiago, Chile

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

Temuco, Región de la Araucanía, Chile

InfektioResearch ( Site 1203)

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Koeln ( Site 1206)

Cologne, North Rhine-Westphalia, Germany

Medizentrum Essen Borbeck ( Site 1200)

Essen, North Rhine-Westphalia, Germany

Novopraxis Berlin GbR ( Site 1201)

Berlin, , Germany

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)

Hamburg, , Germany

Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)

Hamburg, , Germany

Lakeland Clinical Trials ( Site 3102)

Rotorua, Bay of Plenty, New Zealand

P3 Research - Tauranga ( Site 3100)

Tauranga, Bay of Plenty, New Zealand

Southern Clinical Trials Ltd ( Site 3104)

Christchurch, Canterbury, New Zealand

Southern Clinical Trials Waitemata Ltd ( Site 3105)

Auckland, , New Zealand

P3 Research - Wellington ( Site 3101)

Wellington, , New Zealand

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

Bayamón, , Puerto Rico

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

Caguas, , Puerto Rico

Clinical Research Investigator Group ( Site 0611)

Canovanas, , Puerto Rico

Ponce School Of Medicine Caimed Center ( Site 0602)

Ponce, , Puerto Rico

Clinical Research Puerto Rico ( Site 0600)

San Juan, , Puerto Rico

Gachon University Gil Medical Center ( Site 3205)

Namdong-gu, Incheon, South Korea

Korea University Ansan Hospital ( Site 3201)

Ansan-si, Kyonggi-do, South Korea

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

Suwon, Kyonggi-do, South Korea

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

Suwon, Kyonggi-do, South Korea

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

Deagu, Taegu-Kwangyokshi, South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

Samsung Medical Center ( Site 3211)

Seoul, , South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

Korea University Guro Hospital ( Site 3200)

Seoul, , South Korea

ProbarE ( Site 1400)

Lund, Skåne County, Sweden

CTC Karolinska ( Site 1405)

Solna, Stockholm County, Sweden

ProbarE i Stockholm AB ( Site 1401)

Stockholm, Stockholm County, Sweden

Studieenheten Akademiskt Specialistcentrum ( Site 1403)

Stockholm, Stockholm County, Sweden

CTC MTC ( Site 1404)

Uppsala, Uppsala County, Sweden

National Cheng Kung University Hospital ( Site 3301)

Tainan City, , Taiwan

National Taiwan University Hospital ( Site 3300)

Taipei, , Taiwan

Taipei Medical University Hospital ( Site 3302)

Taipei, , Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 3303)

Taoyuan District, , Taiwan

Sakarya Training and Research Hospital ( Site 2205)

Adapazarı, Sakarya, Turkey (Türkiye)

Hacettepe Universite Hastaneleri ( Site 2204)

Ankara, , Turkey (Türkiye)

Ankara City Hospital ( Site 2200)

Ankara, , Turkey (Türkiye)

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)

Istanbul, , Turkey (Türkiye)

Countries

United States; Australia; Belgium; Chile; Germany; New Zealand; Puerto Rico; South Korea; Sweden; Taiwan; Turkey (Türkiye)

References

Platt HL, Bruno C, Buntinx E, Pelayo E, Garcia-Huidobro D, Barranco-Santana EA, Sjoberg F, Song JY, Grijalva CG, Orenstein WA, Morgan L, Fernsler D, Xu W, Waleed M, Li J, Buchwald UK; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis. 2024 Oct;24(10):1141-1150. doi: 10.1016/S1473-3099(24)00344-X. Epub 2024 Jul 1.

Reference Type: RESULT

PMID: 38964361 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26092&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

V116-003

Identifier Type: OTHER

Identifier Source: secondary_id

2022-000258-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V116-003

Identifier Type: -

Identifier Source: org_study_id