A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

RECRUITING

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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Conditions:

🦠 Pneumococcal Infection

🗓️ Study Start (Actual) 18 January 2024

🗓️ Primary Completion (Estimated) 12 February 2025

✅ Study Completion (Estimated) 12 February 2025

👥 Enrollment (Estimated) 820

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE3

Locations:

📍 Birmingham, Alabama, United States

📍 Phoenix, Arizona, United States

📍 Madera, California, United States

📍 Colorado Springs, Colorado, United States

📍 Orlando, Florida, United States

📍 Tampa, Florida, United States

📍 Macon, Georgia, United States

📍 Blackfoot, Idaho, United States

📍 Idaho Falls, Idaho, United States

📍 Rexburg, Idaho, United States

📍 Louisville, Kentucky, United States

📍 Lafayette, Louisiana, United States

📍 Gulfport, Mississippi, United States

📍 Hastings, Nebraska, United States

📍 Lincoln, Nebraska, United States

📍 Albuquerque, New Mexico, United States

📍 Vestal, New York, United States

📍 Chickasha, Oklahoma, United States

📍 Greenville, South Carolina, United States

📍 Spartanburg, South Carolina, United States

📍 Austin, Texas, United States

📍 Brownsville, Texas, United States

📍 DeSoto, Texas, United States

📍 Mesquite, Texas, United States

📍 Layton, Utah, United States

📍 West Jordan, Utah, United States

📍 Halifax, Nova Scotia, Canada

📍 Hamilton, Ontario, Canada

📍 Ottawa, Ontario, Canada

📍 Montréal, Quebec, Canada

📍 Pierrefonds, Quebec, Canada

📍 Quebec City, Quebec, Canada

📍 Temuco, Araucania, Chile

📍 Santiago, Region M. De Santiago, Chile

📍 Rionegro, Antioquia, Colombia

📍 Montería, Cordoba, Colombia

📍 Cali, Valle Del Cauca, Colombia

📍 Kokkola, Mellersta Osterbotten, Finland

📍 Tampere, Pirkanmaa, Finland

📍 Oulu, Pohjois-Pohjanmaa, Finland

📍 Seinäjoki, Sodra Osterbotten, Finland

📍 Espoo, Uusimaa, Finland

📍 Helsinki, Uusimaa, Finland

📍 Turku, Varsinais-Suomi, Finland

📍 Caen, Calvados, France

📍 Lille, Nord, France

📍 Paris, France

📍 Haifa, Israel

📍 Jerusalem, Israel

📍 Petah-Tikva, Israel

📍 Yokohama, Kanagawa, Japan

📍 Haebaru, Okinawa, Japan

📍 Bunkyo-ku, Tokyo, Japan

📍 Edogawa-ku, Tokyo, Japan

📍 Miyazaki, Japan

📍 Okayama, Japan

📍 Saitama, Japan

📍 Wroclaw, Dolnoslaskie, Poland

📍 Bydgoszcz, Kujawsko-pomorskie, Poland

📍 Lodz, Lodzkie, Poland

📍 Lomianki, Mazowieckie, Poland

📍 Badalona, Barcelona, Spain

📍 Esplugues de Llobregat, Barcelona, Spain

📍 Barcelona, Cataluna, Spain

📍 Santiago de Compostela, La Coruna, Spain

📍 Madrid, Madrid, Comunidad De, Spain

📍 Leganés, Madrid, Spain

📍 Madrid, Spain

📍 Sevilla, Spain

📍 Solna, Stockholms Lan, Sweden

📍 Umeå, Vasterbottens Lan, Sweden

📍 Mölndal, Vastra Gotalands Lan, Sweden

📍 Bangkoknoi, Krung Thep Maha Nakhon, Thailand

📍 Pathumwan, Krung Thep Maha Nakhon, Thailand

📍 Ratchathewi, Krung Thep Maha Nakhon, Thailand

📍 Hat Yai, Songkhla, Thailand

📍 Sarçam, Adana, Turkey

📍 Ankara, Turkey

📍 Istanbul, Turkey

📍 İzmir, Turkey

📍 Kayseri, Turkey

More locations available...

📋 Eligibility Criteria

Description

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:

* Has previously received PPSV23 vaccine
* Has a history of active hepatitis within 3 months before study vaccination
* History of invasive pneumococcal disease within 3 years before study vaccination

Ages Eligible for Study: 2 Years to 17 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 11 December 2023
First Submitted that Met QC Criteria 11 December 2023
First Posted 20 December 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 26 July 2024
Last Update Posted 30 July 2024
Last Verified July 2024