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Pneumococcal InfectionPhase 3NCT05425732

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

A Phase 3 study testing V116 and PCV20 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 112 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumococcal Infection
What is being tested?
V116 and PCV20
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,663 participants
Where
112 sitesin 11 countries
Study dates
13 Jul 2022to 18 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

112 sites in 11 countries.

112 sites in 11 countries

United States60 sites

  • JEM Research Institute ( Site 0072)

    Atlantis, Florida, 33462

  • Lynn Institute of Denver ( Site 0012)

    Aurora, Colorado, 80012

  • Tekton Research, Inc. ( Site 0053)

    Austin, Texas, 78745

  • Central Research Associates ( Site 0067)

    Birmingham, Alabama, 35205

  • Charlottesville Medical Research ( Site 0034)

    Charlottesville, Virginia, 22911

  • Aventiv Research Inc ( Site 0044)

    Columbus, Ohio, 43213

  • Alliance for Multispecialty Research, LLC ( Site 0015)

    Coral Gables, Florida, 33134

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

    Dallas, Texas, 75224

  • Hillcrest Medical Research ( Site 0049)

    DeLand, Florida, 32720

  • Skyline Medical Center/CCT Research ( Site 0028)

    Elkhorn, Nebraska, 68022

  • Southland Clinical Research Center-Research ( Site 0054)

    Fountain Valley, California, 92708

  • Methodist Physicians Clinic/CCT Research ( Site 0058)

    Fremont, Nebraska, 68025

  • Lenzmeier Family Medicine/CCT Research ( Site 0006)

    Glendale, Arizona, 85308

  • Velocity Clinical Research, Greenville ( Site 0043)

    Greenville, South Carolina, 29615

  • Olympus Family Medicine/CCT Research ( Site 0074)

    Holladay, Utah, 84117

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

    Horseheads, New York, 14845

  • Elixir Research Group - W Houston ( Site 0068)

    Houston, Texas, 77077

  • Clinical Research Prime ( Site 0010)

    Idaho Falls, Idaho, 83404

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

    Jacksonville, Florida, 32204

  • Alliance for Multispecialty Research, LLC ( Site 0026)

    Kansas City, Missouri, 64114

  • Sunwise Clinical Research ( Site 0024)

    Lafayette, California, 94549

  • East Coast Institute for Research ( Site 0071)

    Lake City, Florida, 32055

  • Chemidox Clinical Trials ( Site 0048)

    Lancaster, California, 93534

  • Healor Primary Care / CCT Research ( Site 0056)

    Las Vegas, Nevada, 89102

  • Excel Clinical Research, LLC ( Site 0077)

    Las Vegas, Nevada, 89109

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

    Las Vegas, Nevada, 89119

  • Epic Clinical Research ( Site 0082)

    Lewisville, Texas, 75067

  • Baptist Health Center For Clinical Research ( Site 0019)

    Little Rock, Arkansas, 72205

  • DCOL Center for Clinical Research ( Site 0051)

    Longview, Texas, 75605

  • Advanced Medical Research ( Site 0002)

    Maumee, Ohio, 43537

  • Solaris Clinical Research ( Site 0008)

    Meridian, Idaho, 83646

  • Desert Clinical Research/ CCT Research ( Site 0040)

    Mesa, Arizona, 85213

  • L&C Professional Medical Research Institute ( Site 0025)

    Miami, Florida, 33144

  • Advanced Medical Research Institute ( Site 0014)

    Miami, Florida, 33174

  • Trial Management Associates ( Site 0089)

    Myrtle Beach, South Carolina, 29572

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

    Newport News, Virginia, 23606

  • Meridian Clinical Research, LLC ( Site 0045)

    Norfolk, Nebraska, 68701

  • Lynn Institute of Norman ( Site 0001)

    Norman, Oklahoma, 73072

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

    Ogden, Utah, 84405

  • Lynn Health Science Institute ( Site 0005)

    Oklahoma City, Oklahoma, 73112

  • Headlands Research Orlando ( Site 0031)

    Orlando, Florida, 32819

  • Foothills Research Center/ CCT Research ( Site 0021)

    Phoenix, Arizona, 85044

  • Research Your Health ( Site 0042)

    Plano, Texas, 75093

  • Summit Headlands ( Site 0047)

    Portland, Oregon, 97210

  • Paradigm Clinical Research Centers, Inc ( Site 0018)

    Redding, California, 96001

  • Peninsula Research Associates ( Site 0079)

    Rolling Hills Estates, California, 90274

  • IMA Clinical Research San Antonio ( Site 0009)

    San Antonio, Texas, 78229

  • VIP Trials ( Site 0086)

    San Antonio, Texas, 78230

  • Acclaim Clinical Research ( Site 0083)

    San Diego, California, 92120

  • Millennium Clinical Trials ( Site 0013)

    Simi Valley, California, 93065

  • MultiCare Rockwood Cheney Clinic ( Site 0037)

    Spokane, Washington, 99204

  • Genesis Clinical Research, LLC ( Site 0016)

    Tampa, Florida, 33603

  • Clinical Research Trials of Florida ( Site 0007)

    Tampa, Florida, 33607

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

    Tempe, Arizona, 85283

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

    Tomball, Texas, 77375

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

    Troy, Michigan, 48098

  • Lynn Institute of Tulsa ( Site 0084)

    Tulsa, Oklahoma, 74135

  • Versailles Family Medicine / CCT Research ( Site 0063)

    Versailles, Kentucky, 40383

  • Palm Beach Research Center ( Site 0060)

    West Palm Beach, Florida, 33409

  • Paradigm Clinical Research Centers, Inc ( Site 0027)

    Wheat Ridge, Colorado, 80033

Other trials in United States

South Korea12 sites

  • Korea University Ansan Hospital ( Site 3201)

    Ansan-si, Kyonggi-do, 15355

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

    Deagu, Taegu-Kwangyokshi, 41404

  • Gachon University Gil Medical Center ( Site 3205)

    Namdong-gu, Incheon, 21565

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

    Seoul, 03312

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

    Seoul, 03722

  • Samsung Medical Center ( Site 3211)

    Seoul, 06351

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

    Seoul, 06591

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

    Seoul, 07441

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

    Seoul

  • Korea University Guro Hospital ( Site 3200)

    Seoul

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

    Suwon, Kyonggi-do, 16247

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

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Germany6 sites

  • Novopraxis Berlin GbR ( Site 1201)

    Berlin, 10117

  • Universitaetsklinikum Koeln ( Site 1206)

    Cologne, North Rhine-Westphalia, 50937

  • Medizentrum Essen Borbeck ( Site 1200)

    Essen, North Rhine-Westphalia, 45355

  • InfektioResearch ( Site 1203)

    Frankfurt am Main, Hesse, 60596

  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)

    Hamburg, 20246

  • Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)

    Hamburg, 20354

Other trials in Germany

Australia5 sites

  • Emeritus Research ( Site 3004)

    Botany, New South Wales, 2019

  • Paratus Clinical Research Canberra ( Site 3000)

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research ( Site 3003)

    Camberwell, Victoria, 3124

  • Paratus Clinical Research Central Coast ( Site 3001)

    Kanwal, New South Wales, 2259

  • Westmead Hospital ( Site 3005)

    Westmead, New South Wales, 2145

Other trials in Australia

New Zealand5 sites

  • Southern Clinical Trials Waitemata Ltd ( Site 3105)

    Auckland, 0626

  • Southern Clinical Trials Ltd ( Site 3104)

    Christchurch, Canterbury, 8013

  • Lakeland Clinical Trials ( Site 3102)

    Rotorua, Bay of Plenty, 3010

  • P3 Research - Tauranga ( Site 3100)

    Tauranga, Bay of Plenty, 3110

  • P3 Research - Wellington ( Site 3101)

    Wellington, 6021

Other trials in New Zealand

Puerto Rico5 sites

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

    Bayamón, 00961

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

    Caguas, 00725

  • Clinical Research Investigator Group ( Site 0611)

    Canovanas, 00729

  • Ponce School Of Medicine Caimed Center ( Site 0602)

    Ponce, 00716

  • Clinical Research Puerto Rico ( Site 0600)

    San Juan, 00909

Other trials in Puerto Rico

Sweden5 sites

  • ProbarE ( Site 1400)

    Lund, Skåne County, 222 22

  • CTC Karolinska ( Site 1405)

    Solna, Stockholm County, 171 64

  • ProbarE i Stockholm AB ( Site 1401)

    Stockholm, Stockholm County, 113 29

  • Studieenheten Akademiskt Specialistcentrum ( Site 1403)

    Stockholm, Stockholm County, 113 61

  • CTC MTC ( Site 1404)

    Uppsala, Uppsala County, 752 37

Other trials in Sweden

Chile4 sites

  • Universidad San Sebastian - Providencia ( Site 0514)

    Providencia, Region M. de Santiago, 7500000

  • Espacio Eme ( Site 0509)

    Santiago, Region M. de Santiago, 7770086

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)

    Santiago, Region M. de Santiago, 8330034

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

    Temuco, Araucania, 4781151

Other trials in Chile

Taiwan4 sites

  • National Cheng Kung University Hospital ( Site 3301)

    Tainan, 704

  • National Taiwan University Hospital ( Site 3300)

    Taipei, 10002

  • Taipei Medical University Hospital ( Site 3302)

    Taipei, 110

  • Chang Gung Medical Foundation-Linkou Branch ( Site 3303)

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)4 sites

  • Sakarya Training and Research Hospital ( Site 2205)

    Adapazarı, Sakarya, 54100

  • Hacettepe Universite Hastaneleri ( Site 2204)

    Ankara, 06230

  • Ankara City Hospital ( Site 2200)

    Ankara, 06800

  • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)

    Istanbul, 34303

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Anima Diepenbeek ( Site 1003)

    Diepenbeek, Limburg, 3590

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

    Erpent, Namur, 5101

Other trials in Belgium

About this study

Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults

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.

Being tested
V116, PCV20
Medical subject headings
Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V116Biological

    Also called Pneumococcal 21-valent Conjugate Vaccine

    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.

  • PCV20Biological

    Also called Prevnar 20™, APEXXNAR™

    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.

Study groups in NCT05425732
Study groupRoleWhat they receive
Cohort 1 V116ExperimentalPneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.
Receives: Biological: V116
Cohort 1 PCV20Active comparatorPneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.
Receives: Biological: PCV20
Cohort 2 V116ExperimentalPneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
Receives: Biological: V116
Cohort 2 PCV20Active comparatorPneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
Receives: Biological: PCV20

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 5 days post-vaccination

  2. 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)

    Measured: Up to 5 days post-vaccination

  3. 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.

    Measured: Up to 194 days post-vaccination

  4. 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.

    Measured: Day 30 post-vaccination

  5. 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.

    Measured: Baseline and Day 30 post-vaccination

  6. 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.

    Measured: Day 30 post-vaccination

Secondary outcomes (7)

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

    The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being > 50 percentage points (one-sided p-value < 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.

    Measured: Baseline and Day 30 post-vaccination

  2. 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

    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 for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.

    Measured: Day 30 post-vaccination

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

    The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC 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, Cohort 2 were not analyzed in this outcome measure.

    Measured: Day 30 post-vaccination

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

    The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. 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.

    Measured: Baseline and Day 30 post-vaccination

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

    The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. 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.

    Measured: Baseline and Day 30 post-vaccination

  6. Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20

    Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. 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.

    Measured: Baseline and Day 30 post-vaccination

  7. Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20

    Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. 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.

    Measured: Baseline and Day 30 post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start13 Jul 2022
  3. Primary completion18 May 2023
  4. Study completion18 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,663 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425732
Sponsor's protocol ID
V116-003
Other IDs
V116-003, 2022-000258-27
Status last verified
Oct 2024
First submitted
15 Jun 2022
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • 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.

    PubMed 38964361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V116 and PCV20 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 112 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, South Korea, Germany, Australia, New Zealand and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Solicited Injection-site Adverse Events (AEs) (time frame: Up to 5 days post-vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425732, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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