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New vaccine shows promise in protecting older adults from pneumococcal disease

NCT ID NCT05569954

Prevention Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new vaccine called V116 in adults aged 50 and older to see if it is safe and works better than the current vaccine (PPSV23) at preventing pneumococcal disease, which can cause pneumonia and other serious infections. About 1,500 healthy adults received either V116 or the standard vaccine. Researchers measured side effects and immune responses 30 days after vaccination. The goal was to show that V116 is at least as good as the current vaccine for common strains and better for nine unique strains.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,484 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal disease

Contacts and locations

Locations

  • ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)

    Ankara, 06230, Turkey (Türkiye)

  • Accellacare - Northamptonshire ( Site 1403)

    Corby, Northamptonshire, NN18 9EZ, United Kingdom

  • Accellacare - Warwickshire ( Site 1404)

    Coventry, Warwickshire, CV3 4FJ, United Kingdom

  • Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)

    Shipley, Bradford, BD18 3SA, United Kingdom

  • Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)

    Istanbul, 34303, Turkey (Türkiye)

  • Asan Medical Center ( Site 1809)

    Seoul, 05505, South Korea

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

    London, England, EC1M 6BQ, United Kingdom

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

    Barcelona, 08023, Spain

  • Chang Gung Medical Foundation-Linkou Branch ( Site 1902)

    Taoyuan, 333, Taiwan

  • Chonnam National University Hospital-Infectious Diseases ( Site 1811)

    Gwangju, Kwangju-Kwangyokshi, 61469, South Korea

  • Chungnam national university hospital ( Site 1814)

    Junggu, Taejon-Kwangyokshi, 35015, South Korea

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

    Sakhnin, 3081000, Israel

  • Dong-A University Hospital ( Site 1810)

    Busan, Pusan-Kwangyokshi, 49201, South Korea

  • EAP Sardenya ( Site 1102)

    Barcelona, 08025, Spain

  • EBA CENTELLES ( Site 1100)

    Centelles, Catalonia, 08500, Spain

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

    Seoul, 07985, South Korea

  • Fundacion Estudios Clinicos ( Site 0200)

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Fundacion Valle del Lili- CIC ( Site 0415)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)

    Valencia, Valenciana, Comunitat, 46015, Spain

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

    Ankara, 06560, Turkey (Türkiye)

  • Hacettepe Universite Hastaneleri-İnfection ( Site 1300)

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)

    Jerusalem, 9112001, Israel

  • Hallym University Dongtan Sacred Heart Hospital ( Site 1813)

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

  • Hallym University Kangnam Sacred Heart Hospital ( Site 1807)

    Seoul, 07441, South Korea

  • Hospital La Princesa-Clinical Pharmacology ( Site 1115)

    Madrid, 28006, Spain

  • Hospital Universitario Getafe ( Site 1111)

    Getafe, Madrid, Comunidad de, 28905, Spain

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

    Barranquilla, Atlántico, 80020, Colombia

  • InfektioResearch ( Site 0903)

    Frankfurt am Main, Hesse, 60596, Germany

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

    Kaohsiung City, 807, Taiwan

  • Korea University Ansan Hospital ( Site 1801)

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

  • Korea University Guro Hospital ( Site 1800)

    Seoul, 08308, South Korea

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

    Deagu, Taegu-Kwangyokshi, 41404, South Korea

  • Layton Medical Centre ( Site 1400)

    Blackpool, Lancashire, FY3 7EN, United Kingdom

  • Medizentrum Essen Borbeck ( Site 0902)

    Essen, North Rhine-Westphalia, 45355, Germany

  • Meir Medical Center-Infectious unit ( Site 1003)

    Kfar Saba, 4428164, Israel

  • National Cheng Kung University Hospital ( Site 1901)

    Tainan, 704, Taiwan

  • National Taiwan University Hospital ( Site 1900)

    Taipei, 100, Taiwan

  • Northern Beaches Clinical Research ( Site 1502)

    Brookvale, New South Wales, 2100, Australia

  • Optimal Clinical Trials ( Site 1600)

    Auckland, 1010, New Zealand

  • P3 Research - Lower Hutt ( Site 1601)

    Lower Hutt, Wellington Region, 5010, New Zealand

  • P3 Research - Palmerston North ( Site 1602)

    Palmerston North, Manawatu-Wanganui, 4414, New Zealand

  • Paratus Clinical Research Brisbane ( Site 1501)

    Albion, Queensland, 4010, Australia

  • Paratus Clinical Research Western Sydney ( Site 1500)

    Blacktown, New South Wales, 2148, Australia

  • Rambam Health Care Campus ( Site 1002)

    Haifa, 3109601, Israel

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

    London, England, NW32QG, United Kingdom

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

    Sancaktepe, Istanbul, 34785, Turkey (Türkiye)

  • Sheba Medical Center ( Site 1000)

    Ramat Gan, 5265601, Israel

  • Soon Chun Hyang University Bucheon Hospital ( Site 1812)

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

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

    Seoul, 06591, South Korea

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

    Suwon, Kyonggi-do, 16247, South Korea

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

    Seoul, 03312, South Korea

  • Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)

    Hamburg, 20246, Germany

  • Universitaetsklinikum Koeln ( Site 0900)

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Wonju Severance Christian Hospital ( Site 1808)

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

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

    München, Bavaria, 81675, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.