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New vaccine aims to shield High-Risk adults from pneumococcal disease

NCT ID NCT05696080

Vaccine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 3 study tested a new vaccine called V116 in 518 adults aged 18 to 64 who are at increased risk for pneumococcal disease due to conditions like diabetes or chronic lung disease. The vaccine targets 21 strains of the bacteria that cause pneumonia and other infections. Researchers compared V116 to an existing 15-valent vaccine plus a 23-valent polysaccharide vaccine, checking safety and immune response. The goal is to see if V116 offers broader, more convenient protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pneumococcal 21-valent conjugate vaccine (V116)
What this could lead to
If successful, V116 could provide broader protection against pneumococcal disease than current vaccines, potentially reducing infections in high-risk adults.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The vaccine may not prove superior to existing vaccines, and side effects like injection-site pain or fatigue are possible.

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

518 people

The number who actually took part.

Started

Feb 2023

Finished

Feb 2024

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

18 to 64 years

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: * 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.

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Conditions

The condition(s) this trial relates to.

pneumococcal infection

As listed by the trial registrant

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

Pneumococcal infection

Contacts and locations

Locations

  • Aventiv Research ( Site 0022)

    Mesa, Arizona, 85206, United States

  • CESFAM Esmeralda ( Site 1009)

    Santiago, Region M. de Santiago, 9340000, Chile

  • CGM Research Trust ( Site 0505)

    Christchurch, Canterbury, 8011, New Zealand

  • Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004)

    Santiago, Region M. de Santiago, 8330034, Chile

  • Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008)

    Santiago, Region M. de Santiago, 7500692, Chile

  • Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010)

    Talca, Maule Region, 3460000, Chile

  • Centrum Medyczne Medyk ( Site 0602)

    Rzeszów, Podkarpackie Voivodeship, 35-055, Poland

  • Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607)

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

  • Centrum Medyczne Pratia Katowice ( Site 0604)

    Katowice, Silesian Voivodeship, 40-081, Poland

  • Clinical Medical Research ( Site 0605)

    Katowice, Silesian Voivodeship, 40-156, Poland

  • Clinique de médecine Urbaine du Quartier Latin ( Site 0111)

    Montreal, Quebec, H2L 4E9, Canada

  • Clinmedica Research Sp. z. o. o. ( Site 0603)

    Skierniewice, Łódź Voivodeship, 96-100, Poland

  • Diex Recherche Trois-Rivieres ( Site 0110)

    Trois-Rivières, Quebec, G9A 4P3, Canada

  • Diex Recherche Victoriavile Inc. ( Site 0102)

    Victoriaville, Quebec, G6P 6P6, Canada

  • EmVenio Research ( Site 0018)

    Fort Worth, Texas, 27713, United States

  • G A Research Associates ( Site 0100)

    Moncton, New Brunswick, E1G 1A7, Canada

  • Hallym University Kangdong Sacred Heart Hospital ( Site 0301)

    Seoul, 05355, South Korea

  • Hallym University Sacred Heart Hospital ( Site 0303)

    Anyang-si, Kyonggi-do, 14068, South Korea

  • Hamilton Medical Research Group ( Site 0107)

    Hamilton, Ontario, L8M 1K7, Canada

  • Holdsworth House Medical Practice ( Site 0402)

    Darlinghurst, New South Wales, 2010, Australia

  • Holston Medical Group ( Site 0010)

    Kingsport, Tennessee, 37660, United States

  • Hospital Dr. Hernán Henríquez Aravena ( Site 1001)

    Temuco, Araucania, 4781151, Chile

  • IN VIVO ( Site 0601)

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

  • Indago Research & Health Center, Inc ( Site 0002)

    Hialeah, Florida, 33012, United States

  • Konkuk University Medical Center ( Site 0302)

    Seoul, 05030, South Korea

  • Korea University Anam Hospital ( Site 0305)

    Seoul, 02841, South Korea

  • MICS Centrum Medyczne Torun ( Site 0606)

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

  • Manna Research Mirabel ( Site 0105)

    Mirabel, Quebec, J7J 2K8, Canada

  • Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200)

    Kurume, Fukuoka, 830-0011, Japan

  • Mid Hudson Medical Research ( Site 0008)

    New Windsor, New York, 12553, United States

  • Milestone Research Inc. ( Site 0106)

    London, Ontario, N5W 6A2, Canada

  • P3 Research - Lower Hutt ( Site 0508)

    Lower Hutt, Wellington Region, 5010, New Zealand

  • P3 Research - Tauranga ( Site 0507)

    Tauranga, Bay of Plenty, 3110, New Zealand

  • P3 Research - Wellington ( Site 0503)

    Wellington, 6021, New Zealand

  • Pacific Clinical Research Network - Forte ( Site 0501)

    Christchurch, Canterbury, 8013, New Zealand

  • Pacific Clinical Research Network - Rotorua ( Site 0500)

    Rotorua, Bay of Plenty, 3010, New Zealand

  • Royal Brisbane and Women's Hospital ( Site 0400)

    Brisbane, Queensland, 4029, Australia

  • SKY Integrative Medical Center/SKYCRNG ( Site 0012)

    Ridgeland, Mississippi, 39157, United States

  • Seoul National University Hospital ( Site 0300)

    Seoul, 03080, South Korea

  • Shimonoseki Medical Center ( Site 0201)

    Shimonoseki, Yamaguchi, 750-0061, Japan

  • Triple O Research Institute, P.A ( Site 0011)

    West Palm Beach, Florida, 33407, United States

  • Universidad San Sebastian - Providencia ( Site 1003)

    Providencia, Region M. de Santiago, 7500000, Chile

  • Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006)

    Santiago, Region M. de Santiago, 8380420, Chile

  • Wenatchee Valley Hospital ( Site 0019)

    Wenatchee, Washington, 98801, United States

More trials for these conditions

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