A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)

NCT05464420 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V116-0042022-000265-41
• Study Type: interventional
• Target: 2,162
• Locations: 8 countries
• Sites: 72

Brief Summary

This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots

  An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

  Up to 5 days

• Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23

  An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.

  Up to 5 days

• Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots

  An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

  Up to 5 days

• Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23

  An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.

  Up to 5 days

• Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots

  An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

  Up to 194 days

• Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23

  An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.

  Up to 194 days

• Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots

  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) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.

  Day 30

Secondary Outcomes (8)

• GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23

  Day 30

• Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots

  Day 30

• GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23

  Day 30

• Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots

  Baseline (Day 1) and Day 30

• Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots

  Baseline (Day 1) and Day 30

Study Arms (4)

V116 Lot 1

EXPERIMENTAL

Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

Biological: V116

V116 Lot 2

EXPERIMENTAL

Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

Biological: V116

V116 Lot 3

EXPERIMENTAL

Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

Biological: V116

PPSV23

ACTIVE COMPARATOR

Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.

Biological: PPSV23

Interventions

V116 BIOLOGICAL

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, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116 Lot 1; V116 Lot 2; V116 Lot 3

PPSV23 BIOLOGICAL

Pneumococcal 23-valent conjugate 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

Also known as: PNEUMOVAX™23

PPSV23

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Has underlying chronic conditions but assessed to be stable as per investigator
• Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
• Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
• Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
• Has a coagulation disorder contraindicating intramuscular vaccination
• Has a recent illness with fever
• Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
• Is expected to receive any pneumococcal vaccine during the study outside of the protocol
• Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
• Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine
• Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
• Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (72)

Desert Clinical Research/ CCT Research ( Site 0019)

Mesa, Arizona, 85213, United States

Location

Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)

Tempe, Arizona, 85283, United States

Location

Baptist Health Center For Clinical Research ( Site 0015)

Little Rock, Arkansas, 72205, United States

Location

Valley Clinical Trials, Inc. ( Site 0023)

Northridge, California, 91325, United States

Location

Artemis Institute for Clinical Research ( Site 0027)

San Diego, California, 92103, United States

Location

Millennium Clinical Trials ( Site 0004)

Simi Valley, California, 93065, United States

Location

Diablo Clinical Research, Inc. ( Site 0022)

Walnut Creek, California, 94598, United States

Location

Lynn Institute of Denver ( Site 0003)

Aurora, Colorado, 80012, United States

Location

Indago Research & Health Center, Inc ( Site 0011)

Hialeah, Florida, 33012, United States

Location

L&C Professional Medical Research Institute ( Site 0012)

Miami, Florida, 33144, United States

Location

Headlands Research Orlando ( Site 0017)

Orlando, Florida, 32819, United States

Location

Clinical Research Trials of Florida ( Site 0001)

Tampa, Florida, 33607, United States

Location

Clinical Research Prime Rexburg ( Site 0040)

Rexburg, Idaho, 83440, United States

Location

Healthcare Research Network - Chicago ( Site 0006)

Flossmoor, Illinois, 60422, United States

Location

Kentucky Pediatric/ Adult Research ( Site 0036)

Bardstown, Kentucky, 40004, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0031)

Kansas City, Missouri, 64114, United States

Location

Methodist Physicians Clinic/CCT Research ( Site 0029)

Fremont, Nebraska, 68025, United States

Location

Healor Primary Care / CCT Research ( Site 0028)

Las Vegas, Nevada, 89102, United States

Location

Axces Research ( Site 0034)

Santa Fe, New Mexico, 87505, United States

Location

Rochester Clinical Research, Inc. ( Site 0033)

Rochester, New York, 14609, United States

Location

M3 Wake Research Associates ( Site 0035)

Raleigh, North Carolina, 27612, United States

Location

Lynn Health Science Institute ( Site 0014)

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research, Providence ( Site 0018)

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Greenville ( Site 0021)

Greenville, South Carolina, 29615, United States

Location

Clinical Research Associates Inc ( Site 0039)

Nashville, Tennessee, 37203, United States

Location

DCOL Center for Clinical Research ( Site 0025)

Longview, Texas, 75605, United States

Location

IMA Clinical Research San Antonio ( Site 0020)

San Antonio, Texas, 78229, United States

Location

Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)

Tomball, Texas, 77375, United States

Location

Charlottesville Medical Research ( Site 0013)

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc. ( Site 0002)

Newport News, Virginia, 23606, United States

Location

Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)

Graz, Styria, 8036, Austria

Location

Medizinische Universitaet Innsbruck ( Site 0301)

Innsbruck, Tyrol, 6020, Austria

Location

Tropeninstitut Wien 1060 ( Site 0300)

Vienna, Vienna, 1060, Austria

Location

Medizinische Universität Wien ( Site 0302)

Vienna, 1090, Austria

Location

Colchester Research Group ( Site 0202)

Truro, Nova Scotia, B2N 1L2, Canada

Location

Hamilton Medical Research Group ( Site 0208)

Hamilton, Ontario, L8M 1K7, Canada

Location

Milestone Research Inc. ( Site 0201)

London, Ontario, N5W 6A2, Canada

Location

Manna Research Toronto ( Site 0209)

Toronto, Ontario, M9W 4L6, Canada

Location

Manna Research Mirabel ( Site 0207)

Mirabel, Quebec, J7J 2K8, Canada

Location

Manna Research Montreal ( Site 0203)

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Q&T Research Sherbrooke Inc. ( Site 0204)

Sherbrooke, Quebec, J1J 2G2, Canada

Location

Diex Recherche Trois-Rivieres ( Site 0206)

Trois-Rivières, Quebec, G9A 4P3, Canada

Location

Sanos Clinic-Sanos Clinic ( Site 0402)

Herlev, Capital Region, 2730, Denmark

Location

Danske Lægers Vaccinations Service - Søborg ( Site 0404)

Søborg, Capital Region, 2860, Denmark

Location

Danske Lægers Vaccinations Service - Århus ( Site 0403)

Aarhus, Central Jutland, 8000, Denmark

Location

Sanos Clinic - Nordjylland ( Site 0401)

Aalborg, North Denmark, 9362, Denmark

Location

Sanos Clinic - Syddanmark ( Site 0400)

Vejle, Region Syddanmark, 7100, Denmark

Location

FVR, Oulun rokotetutkimusklinikka ( Site 0501)

Oulu, North Ostrobothnia, 90220, Finland

Location

FVR, Porin rokotetutkimusklinikka ( Site 0508)

Pori, Satakunta, 28100, Finland

Location

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

FVR, Turun rokotetutkimusklinikka ( Site 0500)

Turku, Southwest Finland, 20520, Finland

Location

FVR, Espoon rokotetutkimusklinikka ( Site 0509)

Espoo, Uusimaa, 02230, Finland

Location

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)

Helsinki, Uusimaa, 00100, Finland

Location

Helsinki East Vaccine Research Clinic ( Site 0502)

Helsinki, Uusimaa, 00930, Finland

Location

Rambam Health Care Campus ( Site 0603)

Haifa, 3109601, Israel

Location

Maccabi Healthcare Services ( Site 0606)

Jerusalem, 71713, Israel

Location

Hadassah Medical Center ( Site 0600)

Jerusalem, 9112001, Israel

Location

Meir Medical Center ( Site 0601)

Kfar Saba, 4428164, Israel

Location

Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)

Ramat Gan, 5265601, Israel

Location

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)

Sakhnin, 3081000, Israel

Location

IN VIVO ( Site 0711)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

MICS Centrum Medyczne Torun ( Site 0706)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)

Lublin, Lublin Voivodeship, 20-095, Poland

Location

Centrum Medyczne Medyk ( Site 0704)

Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

Location

Clinmedica OMC ( Site 0701)

Skierniewice, Łódź Voivodeship, 96-100, Poland

Location

EBA CENTELLES ( Site 0800)

Centelles, Catalonia, 08500, Spain

Location

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)

Valencia, Valenciana, Comunitat, 46015, Spain

Location

Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)

Barcelona, 08023, Spain

Location

EAP Sardenya ( Site 0802)

Barcelona, 08025, Spain

Location

Hospital La Princesa-Clinical Pharmacology ( Site 0815)

Madrid, 28006, Spain

Location

Related Publications (1)

• Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Oct 10;6(10):100748. doi: 10.1016/j.medj.2025.100748. Epub 2025 Jun 20.

  PMID: 40543503 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 19, 2022
• Study Start: August 12, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 25, 2023
• Last Updated: September 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (6); PL (6); IL (6); AU (4); CA (8); US (30); DK (5); FI (7)