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New vaccine V116 aims to shield vulnerable kids from pneumococcal disease

NCT ID NCT06177912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new vaccine called V116 in 882 children and teenagers aged 2 to 17 who have a higher risk of pneumococcal disease due to conditions like diabetes or chronic lung disease. The goal was to see if V116 is as good as or better than the current vaccine PPSV23 at triggering an immune response. The trial is complete, and researchers are now analyzing safety and antibody levels.

What this could mean

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

Active substance
V116 (Pneumococcal 21-valent Conjugate Vaccine)
What this could lead to
If successful, V116 could provide better protection against pneumococcal disease for children and teens with conditions like diabetes or chronic lung disease.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The vaccine may not prove superior to the existing PPSV23 vaccine, and side effects like injection-site pain or fever 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

882 people

The number who actually took part.

Started

Jan 2024

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

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease. * Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment. Exclusion Criteria: * Had a curative procedure/surgery for chronic heart disease and does not require medication, follow-up, additional interventions, or further management per local guidelines. * Has a history of active hepatitis within 3 months before study vaccination. * Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before study vaccination. * Has a history of severely decreased kidney function dialysis, autoimmune related chronic kidney disease, nephrotic syndrome of any cause, or an acute/reversible cause of kidney disease. * Has a history of severe pulmonary hypertension or history of Eisenmenger syndrome. * History of invasive pneumococcal disease within 3 years before study vaccination.

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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 infection

Contacts and locations

Locations

  • Accel Research Sites Network- Nona Pediatric Center ( Site 0109)

    Orlando, Florida, 32829, United States

  • Alliance for Multispecialty Research, LLC ( Site 0140)

    Layton, Utah, 84041, United States

  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)

    Ankara, 06800, Turkey (Türkiye)

  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)

    Ankara, 06590, Turkey (Türkiye)

  • Aquakids Clinic ( Site 1709)

    Edogawa-ku, Tokyo, 133-0056, Japan

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

    Paris, 75019, France

  • Bingham Memorial Hospital ( Site 0149)

    Blackfoot, Idaho, 83221, United States

  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)

    Cali, Valle del Cauca Department, 760042, Colombia

  • CHU Sainte-Justine ( Site 0007)

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de Québec-Université Laval ( Site 0006)

    Québec, Quebec, G1E 7G9, Canada

  • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)

    Santiago de Compostela, La Coruna, 15706, Spain

  • CTC GoCo ( Site 1202)

    Mölndal, Västra Götaland County, 431 53, Sweden

  • CTC Karolinska ( Site 1201)

    Solna, Stockholm County, 171 64, Sweden

  • Canadian Center for Vaccinology ( Site 0004)

    Halifax, Nova Scotia, B3K6R8, Canada

  • Central Research Associates ( Site 0145)

    Birmingham, Alabama, 35205, United States

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

    Caen, Calvados, 14033, France

  • Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)

    Santiago, Region M. de Santiago, 7590943, Chile

  • Centrum Medyczne Pratia Bydgoszcz ( Site 1004)

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

  • Children's Hospital of Eastern Ontario ( Site 0001)

    Ottawa, Ontario, K1H 8L1, Canada

  • Chulalongkorn University-Pediatrics ( Site 1602)

    Pathumwan, Bangkok, 10330, Thailand

  • Clinica Somer ( Site 0405)

    Rionegro, Antioquia, 054040, Colombia

  • Clinical Research Prime ( Site 0105)

    Idaho Falls, Idaho, 83404, United States

  • Clinical Research Prime Rexburg ( Site 0104)

    Rexburg, Idaho, 83440, United States

  • Ege Universitesi Hastanesi ( Site 1306)

    Izmir, 35100, Turkey (Türkiye)

  • Epic Medical Research ( Site 0133)

    DeSoto, Texas, 75115, United States

  • Epic Medical Research - Mesquite ( Site 0144)

    Mesquite, Texas, 75150, United States

  • Epic Medical Research - Oklahoma ( Site 0134)

    Chickasha, Oklahoma, 73018, United States

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)

    Kayseri, 38039, Turkey (Türkiye)

  • FVR, Espoon rokotetutkimusklinikka ( Site 0608)

    Espoo, Uusimaa, 02230, Finland

  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)

    Kokkola, Keski-Pohjanmaa, 67100, Finland

  • FVR, Oulun rokotetutkimusklinikka ( Site 0600)

    Oulu, North Ostrobothnia, 90220, Finland

  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)

    Seinäjoki, South Ostrobothnia, 60100, Finland

  • FVR, Tampereen rokotetutkimusklinikka ( Site 0603)

    Tampere, Pirkanmaa, 33100, Finland

  • FVR, Turun rokotetutkimusklinikka ( Site 0606)

    Turku, Southwest Finland, 20520, Finland

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)

    Bangkoknoi, Bangkok, 10700, Thailand

  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)

    Ratchathewi, Bangkok, 10400, Thailand

  • Fundación Valle del Lili ( Site 0404)

    Cali, Valle del Cauca Department, 760032, Colombia

  • Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)

    Lodz, Łódź Voivodeship, 91-347, Poland

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)

    Seville, 41013, Spain

  • Hacettepe Universite Hastaneleri ( Site 1300)

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Mount Scopus Medical Centre ( Site 0902)

    Jerusalem, 9124001, Israel

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0208)

    Temuco, Araucania, 4781151, Chile

  • Hospital Germans Trias i Pujol ( Site 1104)

    Badalona, Barcelona, 08916, Spain

  • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)

    Santiago, Region M. de Santiago, 8880465, Chile

  • Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)

    Santiago, Region M. de Santiago, 8380418, Chile

  • Hospital Sant Joan de Déu ( Site 1113)

    Esplugues de Llobregat, Barcelona, 08950, Spain

  • Hospital Universitari Vall d'Hebron ( Site 1115)

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11

    Madrid, 28041, Spain

  • Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hospital Universitario Severo Ochoa ( Site 1114)

    Leganés, Madrid, 28911, Spain

  • Hôpital Jeanne de Flandre ( Site 0702)

    Lille, Nord, 59037, France

  • IN VIVO ( Site 1006)

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

  • Juntendo University Hospital ( Site 1700)

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Madera Family Medical Group ( Site 0120)

    Madera, California, 93637, United States

  • McGill University Health Centre - Vaccine Study Centre ( Site 0005)

    Pierrefonds, Quebec, H9H 4Y6, Canada

  • MeVac - Meilahti Vaccine Research Center ( Site 0609)

    Helsinki, Uusimaa, 00290, Finland

  • Midwest Children's Health Research Institute ( Site 0106)

    Lincoln, Nebraska, 68505, United States

  • Midwest Children's Health Research Institute ( Site 0117)

    Lincoln, Nebraska, 68504, United States

  • Midwest Children's Health Research Institute-Research ( Site 0102)

    Lincoln, Nebraska, 68522, United States

  • Midwest Children's Health Research Institute-Research ( Site 0119)

    Lincoln, Nebraska, 68516, United States

  • Miyazaki Prefectural Miyazaki Hospital ( Site 1711)

    Miyazaki, 880-8510, Japan

  • National Hospital Organization Okayama Medical Center ( Site 1713)

    Okayama, 701-1192, Japan

  • Norrlands universitetssjukhus ( Site 1200)

    Umeå, Västerbotten County, 901 85, Sweden

  • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)

    Kanegusuku, Okinawa, 901-1193, Japan

  • Oncomedica S.A.S ( Site 0402)

    Montería, Departamento de Córdoba, 230001, Colombia

  • Optumcare Colorado Springs, LLC ( Site 0113)

    Colorado Springs, Colorado, 80922, United States

  • PanAmerican Clinical Research ( Site 0132)

    Brownsville, Texas, 78521, United States

  • Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)

    Santiago, Region M. de Santiago, 8330077, Chile

  • Premier Clinical Trial Network ( Site 0008)

    Hamilton, Ontario, L8L 5G4, Canada

  • Rambam Health Care Campus ( Site 0900)

    Haifa, 3109601, Israel

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)

    Łomianki, Masovian Voivodeship, 05-092, Poland

  • Saiseikai Yokohamashi Tobu Hospital ( Site 1714)

    Yokohama, Kanagawa, 230-0012, Japan

  • Saitama Prefectural Children's Medical Center ( Site 1702)

    Saitama, 330-8777, Japan

  • Schneider Children's Medical Center ( Site 0903)

    Petah Tikva, 4920235, Israel

  • Sisli Etfal Training and Research Hospital ( Site 1305)

    Istanbul, 34360, Turkey (Türkiye)

  • Songklanagarind hospital-Department of Pediatrics ( Site 1603)

    Hat Yai, Changwat Songkhla, 90110, Thailand

  • Tribe Clinical Research - Spartanburg ( Site 0108)

    Spartanburg, South Carolina, 29301, United States

  • Tribe Clinical Research, LLC-Pediatrics ( Site 0118)

    Greenville, South Carolina, 29607, United States

  • University of Louisville, Norton Children's Research Institute ( Site 0148)

    Louisville, Kentucky, 40202, United States

  • University of Miyazaki Hospital ( Site 1705)

    Miyazaki, 889-1692, Japan

  • University of South Florida-Department of Pediatrics ( Site 0110)

    Tampa, Florida, 33606, United States

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc

    Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

  • Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)

    Macon, Georgia, 31210, United States

  • Velocity Clinical Research, Albuquerque ( Site 0112)

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clinical Research, Austin ( Site 0129)

    Austin, Texas, 78759, United States

  • Velocity Clinical Research, Gulfport ( Site 0115)

    Gulfport, Mississippi, 39503, United States

  • Velocity Clinical Research, Hastings ( Site 0114)

    Hastings, Nebraska, 68901, United States

  • Velocity Clinical Research, Lafayette ( Site 0103)

    Lafayette, Louisiana, 70508, United States

  • Velocity Clinical Research, Phoenix ( Site 0122)

    Phoenix, Arizona, 85006, United States

  • Velocity Clinical Research, Salt Lake City ( Site 0124)

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Vestal ( Site 0121)

    Vestal, New York, 13850, United States

  • Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)

    Sarçam, Adana, 01250, Turkey (Türkiye)

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