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

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infection
• Intervention / Treatment: Biological: PCV20; Biological: V116

• Study Type: Interventional
• Enrollment (Actual): 2663
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Bruce, Australian Capital Territory, Australia, 2617
      • Paratus Clinical Research Canberra ( Site 3000)
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research ( Site 3004)
    • Kanwal, New South Wales, Australia, 2259
      • Paratus Clinical Research Central Coast ( Site 3001)
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital ( Site 3005)
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research ( Site 3003)
• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Anima Diepenbeek ( Site 1003)
  • Namur
    • Erpent, Namur, Belgium, 5101
      • Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)
• Chile
  • Araucania
    • Temuco, Araucania, Chile, 4781151
      • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)
  • Region M. De Santiago
    • Providencia, Region M. De Santiago, Chile, 7500000
      • Universidad San Sebastian - Providencia ( Site 0514)
    • Santiago, Region M. De Santiago, Chile, 7770086
      • Espacio Eme ( Site 0509)
    • Santiago, Region M. De Santiago, Chile, 8330034
      • Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)
• Germany
  • Berlin, Germany, 10117
    • Novopraxis Berlin GbR ( Site 1201)
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)
  • Hamburg, Germany, 20354
    • Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • InfektioResearch ( Site 1203)
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45355
      • Medizentrum Essen Borbeck ( Site 1200)
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Universitaetsklinikum Koeln ( Site 1206)
• Korea, Republic of
  • Seoul, Korea, Republic of, 03312
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center ( Site 3211)
  • Seoul, Korea, Republic of, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital ( Site 3200)
  • Incheon
    • Namdong-gu, Incheon, Korea, Republic of, 21565
      • Gachon University Gil Medical Center ( Site 3205)
  • Kyonggi-do
    • Ansan-si, Kyonggi-do, Korea, Republic of, 15355
      • Korea University Ansan Hospital ( Site 3201)
    • Suwon-si, Kyonggi-do, Korea, Republic of, 16247
      • The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)
    • Suwon-si, Kyonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital-Department of Infectious Diseases ( Site 3209)
  • Taegu-Kwangyokshi
    • Deagu, Taegu-Kwangyokshi, Korea, Republic of, 41404
      • Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)
• New Zealand
  • Auckland, New Zealand, 0626
    • Southern Clinical Trials Waitemata Ltd ( Site 3105)
  • Wellington, New Zealand, 6021
    • P3 Research - Wellington ( Site 3101)
  • Bay Of Plenty
    • Rotorua, Bay Of Plenty, New Zealand, 3010
      • Lakeland Clinical Trials ( Site 3102)
    • Tauranga, Bay Of Plenty, New Zealand, 3110
      • P3 Research - Tauranga ( Site 3100)
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8013
      • Southern Clinical Trials Ltd ( Site 3104)
• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)
  • Caguas, Puerto Rico, 00725
    • San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)
  • Canovanas, Puerto Rico, 00729
    • Clinical Research Investigator Group ( Site 0611)
  • Ponce, Puerto Rico, 00716
    • Ponce School Of Medicine Caimed Center ( Site 0602)
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico ( Site 0600)
• Sweden
  • Skane Lan
    • Lund, Skane Lan, Sweden, 222 22
      • ProbarE ( Site 1400)
  • Stockholms Lan
    • Solna, Stockholms Lan, Sweden, 171 64
      • CTC Karolinska ( Site 1405)
    • Stockholm, Stockholms Lan, Sweden, 113 29
      • ProbarE i Stockholm AB ( Site 1401)
    • Stockholm, Stockholms Lan, Sweden, 113 61
      • Studieenheten Akademiskt Specialistcentrum ( Site 1403)
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 752 37
      • CTC MTC ( Site 1404)
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital ( Site 3301)
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital ( Site 3300)
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital ( Site 3302)
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch ( Site 3303)
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe Universite Hastaneleri ( Site 2204)
  • Ankara, Turkey, 06800
    • Ankara City Hospital ( Site 2200)
  • Istanbul, Turkey, 34303
    • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)
  • Sakarya
    • Adapazarı, Sakarya, Turkey, 54100
      • Sakarya Training and Research Hospital ( Site 2205)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates ( Site 0067)
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Lenzmeier Family Medicine/CCT Research ( Site 0006)
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research/ CCT Research ( Site 0040)
    • Phoenix, Arizona, United States, 85044
      • Foothills Research Center/ CCT Research ( Site 0021)
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Baptist Health Center For Clinical Research ( Site 0019)
  • California
    • Fountain Valley, California, United States, 92708
      • Southland Clinical Research Center-Research ( Site 0054)
    • Lafayette, California, United States, 94549
      • Sunwise Clinical Research ( Site 0024)
    • Lancaster, California, United States, 93534
      • Chemidox Clinical Trials ( Site 0048)
    • Redding, California, United States, 96001
      • Paradigm Clinical Research Centers, Inc ( Site 0018)
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates ( Site 0079)
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research ( Site 0083)
    • Simi Valley, California, United States, 93065
      • Millennium Clinical Trials ( Site 0013)
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Lynn Institute of Denver ( Site 0012)
    • Wheat Ridge, Colorado, United States, 80033
      • Paradigm Clinical Research Centers, Inc ( Site 0027)
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute ( Site 0072)
    • Coral Gables, Florida, United States, 33134
      • Alliance for Multispecialty Research, LLC ( Site 0015)
    • DeLand, Florida, United States, 32720
      • Hillcrest Medical Research ( Site 0049)
    • Jacksonville, Florida, United States, 32204
      • East Coast Institute for Research, LLC ( Site 0070)
    • Lake City, Florida, United States, 32055
      • East Coast Institute for Research ( Site 0071)
    • Miami, Florida, United States, 33144
      • L&C Professional Medical Research Institute ( Site 0025)
    • Miami, Florida, United States, 33174
      • Advanced Medical Research Institute ( Site 0014)
    • Orlando, Florida, United States, 32819
      • Headlands Research Orlando ( Site 0031)
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC ( Site 0016)
    • Tampa, Florida, United States, 33607
      • Clinical Research Trials of Florida ( Site 0007)
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center ( Site 0060)
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Clinical Research Prime ( Site 0010)
    • Meridian, Idaho, United States, 83646
      • Solaris Clinical Research ( Site 0008)
  • Kentucky
    • Versailles, Kentucky, United States, 40383
      • Versailles Family Medicine / CCT Research ( Site 0063)
  • Michigan
    • Troy, Michigan, United States, 48098
      • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC ( Site 0026)
  • Nebraska
    • Elkhorn, Nebraska, United States, 68022
      • Skyline Medical Center/CCT Research ( Site 0028)
    • Fremont, Nebraska, United States, 68025
      • Methodist Physicians Clinic/CCT Research ( Site 0058)
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research, LLC ( Site 0045)
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Healor Primary Care / CCT Research ( Site 0056)
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research, LLC ( Site 0077)
    • Las Vegas, Nevada, United States, 89119
      • Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)
  • New York
    • Horseheads, New York, United States, 14845
      • Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Aventiv Research Inc ( Site 0044)
    • Maumee, Ohio, United States, 43537
      • Advanced Medical Research ( Site 0002)
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman ( Site 0001)
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute ( Site 0005)
    • Tulsa, Oklahoma, United States, 74135
      • Lynn Institute of Tulsa ( Site 0084)
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Headlands ( Site 0047)
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research, Greenville ( Site 0043)
    • Myrtle Beach, South Carolina, United States, 29572
      • Trial Management Associates ( Site 0089)
  • Texas
    • Austin, Texas, United States, 78745
      • Tekton Research, Inc. ( Site 0053)
    • Dallas, Texas, United States, 75224
      • WR-Global Medical Research, LLC ( Site 0065)
    • Houston, Texas, United States, 77077
      • Elixir Research Group - W Houston ( Site 0068)
    • Lewisville, Texas, United States, 75067
      • Epic Clinical Research ( Site 0082)
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research ( Site 0051)
    • Plano, Texas, United States, 75093
      • Research Your Health ( Site 0042)
    • San Antonio, Texas, United States, 78229
      • IMA Clinical Research San Antonio ( Site 0009)
    • San Antonio, Texas, United States, 78230
      • VIP Trials ( Site 0086)
    • Tomball, Texas, United States, 77375
      • Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)
  • Utah
    • Holladay, Utah, United States, 84117
      • Olympus Family Medicine/CCT Research ( Site 0074)
    • Ogden, Utah, United States, 84405
      • South Ogden Family Medicine/ CCT Research ( Site 0022)
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research ( Site 0034)
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc. ( Site 0004)
  • Washington
    • Spokane, Washington, United States, 99204
      • MultiCare Rockwood Cheney Clinic ( Site 0037)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 V116; Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.	Biological: 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.; Other Names: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: Cohort 1 PCV20; Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.	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.; Other Names: Prevnar 20™; APEXXNAR™
Experimental: Cohort 2 V116; Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.	Biological: 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.; Other Names: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: Cohort 2 PCV20; Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.	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.; Other Names: Prevnar 20™; APEXXNAR™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	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.	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	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.	Baseline and Day 30 post-vaccination
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.	Baseline and Day 30 post-vaccination
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.	Baseline and Day 30 post-vaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General 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.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines
• Other Study ID Numbers: V116-003 (Other Identifier: MSD); 2022-000258-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No