Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

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 50 Years of Age or Older

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: PPSV23; Biological: V116

Detailed Description

Selected participants may be eligible for optional immunogenicity or PBMC substudies extension that will investigate the exploratory objectives.

• Study Type: Interventional
• Enrollment (Actual): 1484
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, S2000DEJ
      • Fundacion Estudios Clinicos ( Site 0200)
• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Research Western Sydney ( Site 1500)
    • Brookvale, New South Wales, Australia, 2100
      • Northern Beaches Clinical Research ( Site 1502)
  • Queensland
    • Albion, Queensland, Australia, 4010
      • Paratus Clinical Research Brisbane ( Site 1501)
• Colombia
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 80020
      • IPS Centro Científico Asistencial S.A.S ( Site 0407)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760032
      • Fundacion Valle del Lili- CIC ( Site 0415)
• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)
  • Bavaria
    • München, Bavaria, Germany, 81675
      • klinikum rechts der isar der technischen universität münchen ( Site 0904)
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60596
      • InfektioResearch ( Site 0903)
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Universitaetsklinikum Koeln ( Site 0900)
    • Essen, North Rhine-Westphalia, Germany, 45355
      • Medizentrum Essen Borbeck ( Site 0902)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 1002)
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center-Infectious unit ( Site 1003)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 1000)
  • Sakhnin, Israel, 3081000
    • Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)
• New Zealand
  • Auckland, New Zealand, 1010
    • Optimal Clinical Trials ( Site 1600)
  • Manawatu-Wanganui
    • Palmerston North, Manawatu-Wanganui, New Zealand, 4414
      • P3 Research - Palmerston North ( Site 1602)
  • Wellington Region
    • Lower Hutt, Wellington Region, New Zealand, 5010
      • P3 Research - Lower Hutt ( Site 1601)
• South Korea
  • Seoul, South Korea, 03312
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)
  • Seoul, South Korea, 05505
    • Asan Medical Center ( Site 1809)
  • Seoul, South Korea, 06591
    • The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)
  • Seoul, South Korea, 07441
    • Hallym University Kangnam Sacred Heart Hospital ( Site 1807)
  • Seoul, South Korea, 07985
    • Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital ( Site 1800)
  • Kang-won-do
    • Wŏnju, Kang-won-do, South Korea, 26426
      • Wonju Severance Christian Hospital ( Site 1808)
  • Kwangju-Kwangyokshi
    • Gwangju, Kwangju-Kwangyokshi, South Korea, 61469
      • Chonnam National University Hospital-Infectious Diseases ( Site 1811)
  • Kyonggi-do
    • Ansan-si, Kyonggi-do, South Korea, 15355
      • Korea University Ansan Hospital ( Site 1801)
    • Bucheon-si, Kyonggi-do, South Korea, 14584
      • Soon Chun Hyang University Bucheon Hospital ( Site 1812)
    • Hwaseong-si, Kyonggi-do, South Korea, 18450
      • Hallym University Dongtan Sacred Heart Hospital ( Site 1813)
    • Suwon, Kyonggi-do, South Korea, 16247
      • The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)
  • Pusan-Kwangyokshi
    • Busan, Pusan-Kwangyokshi, South Korea, 49201
      • Dong-A University Hospital ( Site 1810)
  • Taegu-Kwangyokshi
    • Deagu, Taegu-Kwangyokshi, South Korea, 41404
      • Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)
  • Taejon-Kwangyokshi
    • Junggu, Taejon-Kwangyokshi, South Korea, 35015
      • Chungnam national university hospital ( Site 1814)
• Spain
  • Barcelona, Spain, 08023
    • Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)
  • Barcelona, Spain, 08025
    • EAP Sardenya ( Site 1102)
  • Madrid, Spain, 28006
    • Hospital La Princesa-Clinical Pharmacology ( Site 1115)
  • Catalonia
    • Centelles, Catalonia, Spain, 08500
      • EBA CENTELLES ( Site 1100)
  • Madrid, Comunidad de
    • Getafe, Madrid, Comunidad de, Spain, 28905
      • Hospital Universitario Getafe ( Site 1111)
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46015
      • Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital ( Site 1901)
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital ( Site 1900)
  • Taoyuan District, Taiwan, 333
    • Chang Gung Medical Foundation-Linkou Branch ( Site 1902)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universite Hastaneleri-İnfection ( Site 1300)
  • Ankara, Turkey (Türkiye), 06560
    • Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site
  • Istanbul, Turkey (Türkiye), 34303
    • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)
  • Istanbul
    • Sancaktepe, Istanbul, Turkey (Türkiye), 34785
      • Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)
• United Kingdom
  • Bradford
    • Shipley, Bradford, United Kingdom, BD18 3SA
      • Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)
  • England
    • London, England, United Kingdom, EC1M 6BQ
      • Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)
    • London, England, United Kingdom, NW32QG
      • Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)
  • Lancashire
    • Blackpool, Lancashire, United Kingdom, FY3 7EN
      • Layton Medical Centre ( Site 1400)
  • Northamptonshire
    • Corby, Northamptonshire, United Kingdom, NN18 9EZ
      • Accellacare - Northamptonshire ( Site 1403)
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV3 4FJ
      • Accellacare - Warwickshire ( Site 1404)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 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 inclusion 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 PPSV23, 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 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V116; Participants will receive a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1.	Biological: V116; Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.; Other Names: Pneumococcal 21-valent Conjugate Vaccine
Active Comparator: PPSV23; Participants will receive a single IM vaccination of 0.5 mL of PPSV23 on Day 1.	Biological: PPSV23; Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.; Other Names: PNEUMOVAX™23

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 consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.	Up to 5 days postvaccination
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). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.	Up to 5 days postvaccination
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)	An SAE is any untoward medical occurrence 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. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen & Nurminen method.	Up to 6 months postvaccination
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116	Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.	Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116	The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.	Baseline (Day 1) and Day 30 postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs	OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.	Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116	The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.	Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116	The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.	Day 30 postvaccination
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116	The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.	Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116	The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method.	Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116	The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method.	Baseline (Day 1) and Day 30 postvaccination

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Jotterand V, Jagannath V, Diaz AA, Velez JD, Letica A, Perez SN, Clark R, Caraco Y, Degen O, Park KH, Unal S, Wittke F, Hurtado K, Churchill C, Zhang Y, Fernsler D, Li J, Buchwald UK, Platt H. A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults >/=50 Years of Age (STRIDE-10). Vaccines (Basel). 2025 Mar 22;13(4):341. doi: 10.3390/vaccines13040341.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: October 4, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

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; 23-valent pneumococcal capsular polysaccharide vaccine
• Other Study ID Numbers: V116-010; 2022-001785-35 (EudraCT Number); 2022-503144-40-00 (Registry Identifier: EU CT); U1111-1286-5378 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/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
• product manufactured in and exported from the U.S.: Yes