Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008) (STRIDE-8)

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 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease.

The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infection
• Intervention / Treatment: Biological: V116; Biological: Placebo; Biological: PCV15; Biological: PPSV23

• Study Type: Interventional
• Enrollment (Actual): 518
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice ( Site 0402)
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital ( Site 0400)
• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • G A Research Associates ( Site 0100)
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Medical Research Group ( Site 0107)
    • London, Ontario, Canada, N5W 6A2
      • Milestone Research Inc. ( Site 0106)
  • Quebec
    • Mirabel, Quebec, Canada, J7J 2K8
      • Manna Research Mirabel ( Site 0105)
    • Montreal, Quebec, Canada, H2L 4E9
      • Clinique de médecine Urbaine du Quartier Latin ( Site 0111)
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Diex Recherche Trois-Rivieres ( Site 0110)
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Diex Recherche Victoriavile Inc. ( Site 0102)
• Chile
  • Maule Region
    • Talca, Maule Region, Chile, 3460000
      • Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)
  • Region M. de Santiago
    • Providencia, Region M. de Santiago, Chile, 7500000
      • Universidad San Sebastian - Providencia ( Site 1003)
    • Santiago, Region M. de Santiago, Chile, 7500692
      • Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)
    • Santiago, Region M. de Santiago, Chile, 8330034
      • Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)
    • Santiago, Region M. de Santiago, Chile, 8380420
      • Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)
    • Santiago, Region M. de Santiago, Chile, 9340000
      • CESFAM Esmeralda ( Site 1009)
  • Región de la Araucanía
    • Temuco, Región de la Araucanía, Chile, 4781151
      • Hospital Dr. Hernán Henríquez Aravena ( Site 1001)
• Japan
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan, 750-0061
      • Shimonoseki Medical Center ( Site 0201)
• New Zealand
  • Wellington, New Zealand, 6021
    • P3 Research - Wellington ( Site 0503)
  • Bay of Plenty
    • Rotorua, Bay of Plenty, New Zealand, 3010
      • Pacific Clinical Research Network - Rotorua ( Site 0500)
    • Tauranga, Bay of Plenty, New Zealand, 3110
      • P3 Research - Tauranga ( Site 0507)
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • CGM Research Trust ( Site 0505)
    • Christchurch, Canterbury, New Zealand, 8013
      • Pacific Clinical Research Network - Forte ( Site 0501)
  • Wellington Region
    • Lower Hutt, Wellington Region, New Zealand, 5010
      • P3 Research - Lower Hutt ( Site 0508)
• Poland
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-048
      • IN VIVO ( Site 0601)
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
      • Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)
    • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
      • MICS Centrum Medyczne Torun ( Site 0606)
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-055
      • Centrum Medyczne Medyk ( Site 0602)
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Centrum Medyczne Pratia Katowice ( Site 0604)
    • Katowice, Silesian Voivodeship, Poland, 40-156
      • Clinical Medical Research ( Site 0605)
  • Łódź Voivodeship
    • Skierniewice, Łódź Voivodeship, Poland, 96-100
      • Clinmedica Research Sp. z. o. o. ( Site 0603)
• South Korea
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital ( Site 0305)
  • Seoul, South Korea, 03080
    • Seoul National University Hospital ( Site 0300)
  • Seoul, South Korea, 05030
    • Konkuk University Medical Center ( Site 0302)
  • Seoul, South Korea, 05355
    • Hallym University Kangdong Sacred Heart Hospital ( Site 0301)
  • Kyonggi-do
    • Anyang-si, Kyonggi-do, South Korea, 14068
      • Hallym University Sacred Heart Hospital ( Site 0303)
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Aventiv Research ( Site 0022)
  • Florida
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 0002)
    • West Palm Beach, Florida, United States, 33407
      • Triple O Research Institute, P.A ( Site 0011)
  • Mississippi
    • Ridgeland, Mississippi, United States, 39157
      • SKY Integrative Medical Center/SKYCRNG ( Site 0012)
  • New York
    • New Windsor, New York, United States, 12553
      • Mid Hudson Medical Research ( Site 0008)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group ( Site 0010)
  • Texas
    • Fort Worth, Texas, United States, 27713
      • EmVenio Research ( Site 0018)
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital ( Site 0019)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Has documented result(s) of ≥1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with ≥1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements ≤9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration).
• Is receiving stable medical management for the listed risk conditions for ≥3 months with no anticipated major change in treatment expected for the duration of the study and with ≤1 hospitalization directly related to the risk condition.
• Female Is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator.

Exclusion Criteria:

• Has a history of active hepatitis.
• Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1).
• Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1).
• Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class ≥3 or history of Eisenmenger syndrome
• Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria
• 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 before first study vaccination (Day 1).
• Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid.
• Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease.
• Has a coagulation disorder contraindicating intramuscular (IM) vaccination.
• Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine.
• Has a known malignancy that is progressing or has required active treatment <3 years before randomization.
• Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study.
• Has expected survival for <1 year.
• Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol.
• Has 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 at Visit 2 (Day 1).
• Is currently receiving systemic 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.
• Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine.
• Has received any live virus vaccine (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine
• Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of any study vaccine.
• Is receiving chronic home oxygen therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V116 + Placebo; Participants administered a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo on Week 8.	Biological: V116; Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution; Other Names: Pneumococcal 21-valent Conjugate Vaccine; Biological: Placebo; Saline in each 0.5 mL sterile solution
Active Comparator: PCV15 + PPSV23; Participants administered a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.	Biological: PCV15; Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension; Other Names: VAXNEUVANCE™; Biological: PPSV23; Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following 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 in each 0.5 mL sterile solution; 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) From Day 1 Through Day 5 Post-vaccination	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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling.	Up to 5 days following each vaccination
Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination	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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. 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 following each vaccination
Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study	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 another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination.	Up to 194 days following Visit 2 (Day 1)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116	The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116	The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group.
Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23	The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23	The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116	The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)
Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116	The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.	Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Scott PT, Pathirana J, Kato A, Tytus R, Perez CM, Gilchrist NL, Kanou H, Ha Yoo K, Kania G, Nissen M, Russell AF, Fernsler D, Waleed M, Li J, Buchwald UK, Platt HL. A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naive Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. Clin Infect Dis. 2025 Nov 10:ciaf604. doi: 10.1093/cid/ciaf604. Online ahead of print.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): February 16, 2024
• Study Completion (Actual): February 16, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 10, 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: V116-008 (Other Identifier: MSD); jRCT2061220106 (Registry Identifier: jRCT); U1111-1282- 1460 (Registry Identifier: UTN); 2022-502791-22-01 (Registry Identifier: EU CT)

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