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

NCT05425732 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V116-0032022-000258-27
• Study Type: interventional
• Target: 2,663
• Locations: 11 countries
• Sites: 112

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

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.

  Up to 5 days post-vaccination

• Percentage of Participants With Solicited Systemic AEs

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C)

  Up to 5 days post-vaccination

• Percentage of Participants With Vaccine-related Serious AE (SAE)

  A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event, which is determined by the investigator to be related to the vaccine.

  Up to 194 days post-vaccination

• Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20

  The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.

  Day 30 post-vaccination

• Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116

  The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.

  Baseline and Day 30 post-vaccination

• Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116

  The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.

  Day 30 post-vaccination

Secondary Outcomes (7)

• Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes

  Baseline and Day 30 post-vaccination

• Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2

  Day 30 post-vaccination

• Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20

  Day 30 post-vaccination

• Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20

  Baseline and Day 30 post-vaccination

• Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20

  Baseline and Day 30 post-vaccination

Study Arms (4)

Cohort 1 V116

EXPERIMENTAL

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

Biological: V116

Cohort 1 PCV20

ACTIVE COMPARATOR

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

Biological: PCV20

Cohort 2 V116

EXPERIMENTAL

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

Biological: V116

Cohort 2 PCV20

ACTIVE COMPARATOR

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

Biological: PCV20

Interventions

V116 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.

Also known as: Pneumococcal 21-valent Conjugate Vaccine

Cohort 1 V116; Cohort 2 V116

PCV20 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.

Also known as: Prevnar 20™, APEXXNAR™

Cohort 1 PCV20; Cohort 2 PCV20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (112)

Central Research Associates ( Site 0067)

Birmingham, Alabama, 35205, United States

Location

Lenzmeier Family Medicine/CCT Research ( Site 0006)

Glendale, Arizona, 85308, United States

Location

Desert Clinical Research/ CCT Research ( Site 0040)

Mesa, Arizona, 85213, United States

Location

Foothills Research Center/ CCT Research ( Site 0021)

Phoenix, Arizona, 85044, United States

Location

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

Tempe, Arizona, 85283, United States

Location

Baptist Health Center For Clinical Research ( Site 0019)

Little Rock, Arkansas, 72205, United States

Location

Southland Clinical Research Center-Research ( Site 0054)

Fountain Valley, California, 92708, United States

Location

Sunwise Clinical Research ( Site 0024)

Lafayette, California, 94549, United States

Location

Chemidox Clinical Trials ( Site 0048)

Lancaster, California, 93534, United States

Location

Paradigm Clinical Research Centers, Inc ( Site 0018)

Redding, California, 96001, United States

Location

Peninsula Research Associates ( Site 0079)

Rolling Hills Estates, California, 90274, United States

Location

Acclaim Clinical Research ( Site 0083)

San Diego, California, 92120, United States

Location

Millennium Clinical Trials ( Site 0013)

Simi Valley, California, 93065, United States

Location

Lynn Institute of Denver ( Site 0012)

Aurora, Colorado, 80012, United States

Location

Paradigm Clinical Research Centers, Inc ( Site 0027)

Wheat Ridge, Colorado, 80033, United States

Location

JEM Research Institute ( Site 0072)

Atlantis, Florida, 33462, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0015)

Coral Gables, Florida, 33134, United States

Location

Hillcrest Medical Research ( Site 0049)

DeLand, Florida, 32720, United States

Location

East Coast Institute for Research, LLC ( Site 0070)

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research ( Site 0071)

Lake City, Florida, 32055, United States

Location

L&C Professional Medical Research Institute ( Site 0025)

Miami, Florida, 33144, United States

Location

Advanced Medical Research Institute ( Site 0014)

Miami, Florida, 33174, United States

Location

Headlands Research Orlando ( Site 0031)

Orlando, Florida, 32819, United States

Location

Genesis Clinical Research, LLC ( Site 0016)

Tampa, Florida, 33603, United States

Location

Clinical Research Trials of Florida ( Site 0007)

Tampa, Florida, 33607, United States

Location

Palm Beach Research Center ( Site 0060)

West Palm Beach, Florida, 33409, United States

Location

Clinical Research Prime ( Site 0010)

Idaho Falls, Idaho, 83404, United States

Location

Solaris Clinical Research ( Site 0008)

Meridian, Idaho, 83646, United States

Location

Versailles Family Medicine / CCT Research ( Site 0063)

Versailles, Kentucky, 40383, United States

Location

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

Troy, Michigan, 48098, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0026)

Kansas City, Missouri, 64114, United States

Location

Skyline Medical Center/CCT Research ( Site 0028)

Elkhorn, Nebraska, 68022, United States

Location

Methodist Physicians Clinic/CCT Research ( Site 0058)

Fremont, Nebraska, 68025, United States

Location

Meridian Clinical Research, LLC ( Site 0045)

Norfolk, Nebraska, 68701, United States

Location

Healor Primary Care / CCT Research ( Site 0056)

Las Vegas, Nevada, 89102, United States

Location

Excel Clinical Research, LLC ( Site 0077)

Las Vegas, Nevada, 89109, United States

Location

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

Las Vegas, Nevada, 89119, United States

Location

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

Horseheads, New York, 14845, United States

Location

Aventiv Research Inc ( Site 0044)

Columbus, Ohio, 43213, United States

Location

Advanced Medical Research ( Site 0002)

Maumee, Ohio, 43537, United States

Location

Lynn Institute of Norman ( Site 0001)

Norman, Oklahoma, 73072, United States

Location

Lynn Health Science Institute ( Site 0005)

Oklahoma City, Oklahoma, 73112, United States

Location

Lynn Institute of Tulsa ( Site 0084)

Tulsa, Oklahoma, 74135, United States

Location

Summit Headlands ( Site 0047)

Portland, Oregon, 97210, United States

Location

Velocity Clinical Research, Greenville ( Site 0043)

Greenville, South Carolina, 29615, United States

Location

Trial Management Associates ( Site 0089)

Myrtle Beach, South Carolina, 29572, United States

Location

Tekton Research, Inc. ( Site 0053)

Austin, Texas, 78745, United States

Location

WR-Global Medical Research, LLC ( Site 0065)

Dallas, Texas, 75224, United States

Location

Elixir Research Group - W Houston ( Site 0068)

Houston, Texas, 77077, United States

Location

Epic Clinical Research ( Site 0082)

Lewisville, Texas, 75067, United States

Location

DCOL Center for Clinical Research ( Site 0051)

Longview, Texas, 75605, United States

Location

Research Your Health ( Site 0042)

Plano, Texas, 75093, United States

Location

IMA Clinical Research San Antonio ( Site 0009)

San Antonio, Texas, 78229, United States

Location

VIP Trials ( Site 0086)

San Antonio, Texas, 78230, United States

Location

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

Tomball, Texas, 77375, United States

Location

Olympus Family Medicine/CCT Research ( Site 0074)

Holladay, Utah, 84117, United States

Location

South Ogden Family Medicine/ CCT Research ( Site 0022)

Ogden, Utah, 84405, United States

Location

Charlottesville Medical Research ( Site 0034)

Charlottesville, Virginia, 22911, United States

Location

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

Newport News, Virginia, 23606, United States

Location

MultiCare Rockwood Cheney Clinic ( Site 0037)

Spokane, Washington, 99204, United States

Location

Paratus Clinical Research Canberra ( Site 3000)

Bruce, Australian Capital Territory, 2617, Australia

Location

Emeritus Research ( Site 3004)

Botany, New South Wales, 2019, Australia

Location

Paratus Clinical Research Central Coast ( Site 3001)

Kanwal, New South Wales, 2259, Australia

Location

Westmead Hospital ( Site 3005)

Westmead, New South Wales, 2145, Australia

Location

Emeritus Research ( Site 3003)

Camberwell, Victoria, 3124, Australia

Location

Anima Diepenbeek ( Site 1003)

Diepenbeek, Limburg, 3590, Belgium

Location

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

Erpent, Namur, 5101, Belgium

Location

Universidad San Sebastian - Providencia ( Site 0514)

Providencia, Region M. de Santiago, 7500000, Chile

Location

Espacio Eme ( Site 0509)

Santiago, Region M. de Santiago, 7770086, Chile

Location

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)

Santiago, Region M. de Santiago, 8330034, Chile

Location

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

Temuco, Región de la Araucanía, 4781151, Chile

Location

InfektioResearch ( Site 1203)

Frankfurt am Main, Hesse, 60596, Germany

Location

Universitaetsklinikum Koeln ( Site 1206)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Medizentrum Essen Borbeck ( Site 1200)

Essen, North Rhine-Westphalia, 45355, Germany

Location

Novopraxis Berlin GbR ( Site 1201)

Berlin, 10117, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)

Hamburg, 20246, Germany

Location

Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)

Hamburg, 20354, Germany

Location

Lakeland Clinical Trials ( Site 3102)

Rotorua, Bay of Plenty, 3010, New Zealand

Location

P3 Research - Tauranga ( Site 3100)

Tauranga, Bay of Plenty, 3110, New Zealand

Location

Southern Clinical Trials Ltd ( Site 3104)

Christchurch, Canterbury, 8013, New Zealand

Location

Southern Clinical Trials Waitemata Ltd ( Site 3105)

Auckland, 0626, New Zealand

Location

P3 Research - Wellington ( Site 3101)

Wellington, 6021, New Zealand

Location

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

Bayamón, 00961, Puerto Rico

Location

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

Caguas, 00725, Puerto Rico

Location

Clinical Research Investigator Group ( Site 0611)

Canovanas, 00729, Puerto Rico

Location

Ponce School Of Medicine Caimed Center ( Site 0602)

Ponce, 00716, Puerto Rico

Location

Clinical Research Puerto Rico ( Site 0600)

San Juan, 00909, Puerto Rico

Location

Gachon University Gil Medical Center ( Site 3205)

Namdong-gu, Incheon, 21565, South Korea

Location

Korea University Ansan Hospital ( Site 3201)

Ansan-si, Kyonggi-do, 15355, South Korea

Location

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

Suwon, Kyonggi-do, 16247, South Korea

Location

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

Suwon, Kyonggi-do, 16499, South Korea

Location

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

Deagu, Taegu-Kwangyokshi, 41404, South Korea

Location

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

Seoul, 03312, South Korea

Location

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

Seoul, 03722, South Korea

Location

Samsung Medical Center ( Site 3211)

Seoul, 06351, South Korea

Location

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

Seoul, 06591, South Korea

Location

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

Seoul, 07441, South Korea

Location

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

Seoul, South Korea

Location

Korea University Guro Hospital ( Site 3200)

Seoul, South Korea

Location

ProbarE ( Site 1400)

Lund, Skåne County, 222 22, Sweden

Location

CTC Karolinska ( Site 1405)

Solna, Stockholm County, 171 64, Sweden

Location

ProbarE i Stockholm AB ( Site 1401)

Stockholm, Stockholm County, 113 29, Sweden

Location

Studieenheten Akademiskt Specialistcentrum ( Site 1403)

Stockholm, Stockholm County, 113 61, Sweden

Location

CTC MTC ( Site 1404)

Uppsala, Uppsala County, 752 37, Sweden

Location

National Cheng Kung University Hospital ( Site 3301)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 3300)

Taipei, 10002, Taiwan

Location

Taipei Medical University Hospital ( Site 3302)

Taipei, 110, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 3303)

Taoyuan District, 333, Taiwan

Location

Sakarya Training and Research Hospital ( Site 2205)

Adapazarı, Sakarya, 54100, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri ( Site 2204)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara City Hospital ( Site 2200)

Ankara, 06800, Turkey (Türkiye)

Location

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 38964361 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: July 13, 2022
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: October 26, 2024
• Results First Posted: June 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (2); CL (4); SE (5); NZ (5); PR (5); TW (4); TU (4); AU (5); KR (12); US (60); DE (6)