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

NCT05569954 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: V116-0102022-503144-40-00U1111-1286-53782022-001785-35
• Study Type: interventional
• Target: 1,484
• Locations: 11 countries
• Sites: 55

Brief Summary

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).

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs

  Baseline (Day 1) and Day 30 postvaccination

• Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116

  Baseline (Day 1) and Day 30 postvaccination

• Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116

  Day 30 postvaccination

• Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116

  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

  Baseline (Day 1) and Day 30 postvaccination

Study Arms (2)

V116

EXPERIMENTAL

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

Biological: V116

PPSV23

ACTIVE COMPARATOR

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

Biological: PPSV23

Interventions

V116 BIOLOGICAL

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.

Also known as: Pneumococcal 21-valent Conjugate Vaccine

V116

PPSV23 BIOLOGICAL

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.

Also known as: PNEUMOVAX™23

PPSV23

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (55)

Fundacion Estudios Clinicos ( Site 0200)

Rosario, Santa Fe Province, S2000DEJ, Argentina

Location

Paratus Clinical Research Western Sydney ( Site 1500)

Blacktown, New South Wales, 2148, Australia

Location

Northern Beaches Clinical Research ( Site 1502)

Brookvale, New South Wales, 2100, Australia

Location

Paratus Clinical Research Brisbane ( Site 1501)

Albion, Queensland, 4010, Australia

Location

IPS Centro Científico Asistencial S.A.S ( Site 0407)

Barranquilla, Atlántico, 80020, Colombia

Location

Fundacion Valle del Lili- CIC ( Site 0415)

Cali, Valle del Cauca Department, 760032, Colombia

Location

klinikum rechts der isar der technischen universität münchen ( Site 0904)

München, Bavaria, 81675, Germany

Location

InfektioResearch ( Site 0903)

Frankfurt am Main, Hesse, 60596, Germany

Location

Universitaetsklinikum Koeln ( Site 0900)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Medizentrum Essen Borbeck ( Site 0902)

Essen, North Rhine-Westphalia, 45355, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)

Hamburg, 20246, Germany

Location

Rambam Health Care Campus ( Site 1002)

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)

Jerusalem, 9112001, Israel

Location

Meir Medical Center-Infectious unit ( Site 1003)

Kfar Saba, 4428164, Israel

Location

Sheba Medical Center ( Site 1000)

Ramat Gan, 5265601, Israel

Location

Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)

Sakhnin, 3081000, Israel

Location

P3 Research - Palmerston North ( Site 1602)

Palmerston North, Manawatu-Wanganui, 4414, New Zealand

Location

P3 Research - Lower Hutt ( Site 1601)

Lower Hutt, Wellington Region, 5010, New Zealand

Location

Optimal Clinical Trials ( Site 1600)

Auckland, 1010, New Zealand

Location

Wonju Severance Christian Hospital ( Site 1808)

Wŏnju, Kang-won-do, 26426, South Korea

Location

Chonnam National University Hospital-Infectious Diseases ( Site 1811)

Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

Location

Korea University Ansan Hospital ( Site 1801)

Ansan-si, Kyonggi-do, 15355, South Korea

Location

Soon Chun Hyang University Bucheon Hospital ( Site 1812)

Bucheon-si, Kyonggi-do, 14584, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital ( Site 1813)

Hwaseong-si, Kyonggi-do, 18450, South Korea

Location

The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)

Suwon, Kyonggi-do, 16247, South Korea

Location

Dong-A University Hospital ( Site 1810)

Busan, Pusan-Kwangyokshi, 49201, South Korea

Location

Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)

Deagu, Taegu-Kwangyokshi, 41404, South Korea

Location

Chungnam national university hospital ( Site 1814)

Junggu, Taejon-Kwangyokshi, 35015, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)

Seoul, 03312, South Korea

Location

Asan Medical Center ( Site 1809)

Seoul, 05505, South Korea

Location

The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)

Seoul, 06591, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital ( Site 1807)

Seoul, 07441, South Korea

Location

Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)

Seoul, 07985, South Korea

Location

Korea University Guro Hospital ( Site 1800)

Seoul, 08308, South Korea

Location

EBA CENTELLES ( Site 1100)

Centelles, Catalonia, 08500, Spain

Location

Hospital Universitario Getafe ( Site 1111)

Getafe, Madrid, Comunidad de, 28905, Spain

Location

Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)

Valencia, Valenciana, Comunitat, 46015, Spain

Location

Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)

Barcelona, 08023, Spain

Location

EAP Sardenya ( Site 1102)

Barcelona, 08025, Spain

Location

Hospital La Princesa-Clinical Pharmacology ( Site 1115)

Madrid, 28006, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of

Kaohsiung City, 807, Taiwan

Location

National Cheng Kung University Hospital ( Site 1901)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 1900)

Taipei, 100, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 1902)

Taoyuan District, 333, Taiwan

Location

Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)

Sancaktepe, Istanbul, 34785, Turkey (Türkiye)

Location

ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)

Ankara, 06230, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-İnfection ( Site 1300)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site

Ankara, 06560, Turkey (Türkiye)

Location

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)

Istanbul, 34303, Turkey (Türkiye)

Location

Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)

Shipley, Bradford, BD18 3SA, United Kingdom

Location

Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)

London, England, EC1M 6BQ, United Kingdom

Location

Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)

London, England, NW32QG, United Kingdom

Location

Layton Medical Centre ( Site 1400)

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Accellacare - Northamptonshire ( Site 1403)

Corby, Northamptonshire, NN18 9EZ, United Kingdom

Location

Accellacare - Warwickshire ( Site 1404)

Coventry, Warwickshire, CV3 4FJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40333240 RESULT

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: October 4, 2022
• First Posted: October 6, 2022
• Study Start: November 7, 2022
• Primary Completion: October 30, 2023
• Study Completion: February 7, 2025
• Last Updated: March 2, 2026
• Results First Posted: October 31, 2024

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

IL (5); KR (15); AU (3); TW (4); DE (5); AR (1); TU (5); NZ (3); CO (2); GB (6); ES (6)