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

NCT ID: NCT05569954

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2025-02-07

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).

Detailed Description

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

Conditions

Pneumococcal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V116

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

Group Type: EXPERIMENTAL

V116

Intervention Type: 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.

PPSV23

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

Group Type: ACTIVE_COMPARATOR

PPSV23

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Pneumococcal 21-valent Conjugate Vaccine; PNEUMOVAX™23

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Fundacion Estudios Clinicos ( Site 0200)

Rosario, Santa Fe Province, Argentina

Paratus Clinical Research Western Sydney ( Site 1500)

Blacktown, New South Wales, Australia

Northern Beaches Clinical Research ( Site 1502)

Brookvale, New South Wales, Australia

Paratus Clinical Research Brisbane ( Site 1501)

Albion, Queensland, Australia

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

Barranquilla, Atlántico, Colombia

Fundacion Valle del Lili- CIC ( Site 0415)

Cali, Valle del Cauca Department, Colombia

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

München, Bavaria, Germany

InfektioResearch ( Site 0903)

Frankfurt am Main, Hesse, Germany

Universitaetsklinikum Koeln ( Site 0900)

Cologne, North Rhine-Westphalia, Germany

Medizentrum Essen Borbeck ( Site 0902)

Essen, North Rhine-Westphalia, Germany

Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)

Hamburg, , Germany

Rambam Health Care Campus ( Site 1002)

Haifa, , Israel

Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)

Jerusalem, , Israel

Meir Medical Center-Infectious unit ( Site 1003)

Kfar Saba, , Israel

Sheba Medical Center ( Site 1000)

Ramat Gan, , Israel

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

Sakhnin, , Israel

P3 Research - Palmerston North ( Site 1602)

Palmerston North, Manawatu-Wanganui, New Zealand

P3 Research - Lower Hutt ( Site 1601)

Lower Hutt, Wellington Region, New Zealand

Optimal Clinical Trials ( Site 1600)

Auckland, , New Zealand

Wonju Severance Christian Hospital ( Site 1808)

Wŏnju, Kang-won-do, South Korea

Chonnam National University Hospital-Infectious Diseases ( Site 1811)

Gwangju, Kwangju-Kwangyokshi, South Korea

Korea University Ansan Hospital ( Site 1801)

Ansan-si, Kyonggi-do, South Korea

Soon Chun Hyang University Bucheon Hospital ( Site 1812)

Bucheon-si, Kyonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital ( Site 1813)

Hwaseong-si, Kyonggi-do, South Korea

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

Suwon, Kyonggi-do, South Korea

Dong-A University Hospital ( Site 1810)

Busan, Pusan-Kwangyokshi, South Korea

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

Deagu, Taegu-Kwangyokshi, South Korea

Chungnam national university hospital ( Site 1814)

Junggu, Taejon-Kwangyokshi, South Korea

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

Seoul, , South Korea

Asan Medical Center ( Site 1809)

Seoul, , South Korea

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

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital ( Site 1807)

Seoul, , South Korea

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

Seoul, , South Korea

Korea University Guro Hospital ( Site 1800)

Seoul, , South Korea

EBA CENTELLES ( Site 1100)

Centelles, Catalonia, Spain

Hospital Universitario Getafe ( Site 1111)

Getafe, Madrid, Comunidad de, Spain

Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)

Valencia, Valenciana, Comunitat, Spain

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

Barcelona, , Spain

EAP Sardenya ( Site 1102)

Barcelona, , Spain

Hospital La Princesa-Clinical Pharmacology ( Site 1115)

Madrid, , Spain

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

Kaohsiung City, , Taiwan

National Cheng Kung University Hospital ( Site 1901)

Tainan, , Taiwan

National Taiwan University Hospital ( Site 1900)

Taipei, , Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 1902)

Taoyuan District, , Taiwan

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

Sancaktepe, Istanbul, Turkey (Türkiye)

ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)

Ankara, , Turkey (Türkiye)

Hacettepe Universite Hastaneleri-İnfection ( Site 1300)

Ankara, , Turkey (Türkiye)

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

Ankara, , Turkey (Türkiye)

Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)

Istanbul, , Turkey (Türkiye)

Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)

Shipley, Bradford, United Kingdom

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

London, England, United Kingdom

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

London, England, United Kingdom

Layton Medical Centre ( Site 1400)

Blackpool, Lancashire, United Kingdom

Accellacare - Northamptonshire ( Site 1403)

Corby, Northamptonshire, United Kingdom

Accellacare - Warwickshire ( Site 1404)

Coventry, Warwickshire, United Kingdom

Countries

Argentina; Australia; Colombia; Germany; Israel; New Zealand; South Korea; Spain; Taiwan; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: RESULT

PMID: 40333240 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26201&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

2022-503144-40-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1286-5378

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-001785-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V116-010

Identifier Type: -

Identifier Source: org_study_id