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

Completed · Phase 3

Conditions studied: Pneumococcal Infection

In brief

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. 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 pneumococcal disease (PD).

Key facts

Study ID

NCT06177912

Run by

Merck Sharp & Dohme LLC

People needed

882

Starts

2024-01-18

Expected to finish

2025-02-26

Last updated by the study team

2026-03-11

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Velocity Clinical Research, Phoenix ( Site 0122) — Phoenix, Arizona, United States
• Madera Family Medical Group ( Site 0120) — Madera, California, United States
• Optumcare Colorado Springs, LLC ( Site 0113) — Colorado Springs, Colorado, United States
• Accel Research Sites Network- Nona Pediatric Center ( Site 0109) — Orlando, Florida, United States
• University of South Florida-Department of Pediatrics ( Site 0110) — Tampa, Florida, United States
• Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128) — Macon, Georgia, United States
• Bingham Memorial Hospital ( Site 0149) — Blackfoot, Idaho, United States
• Clinical Research Prime ( Site 0105) — Idaho Falls, Idaho, United States
• Clinical Research Prime Rexburg ( Site 0104) — Rexburg, Idaho, United States
• University of Louisville, Norton Children's Research Institute ( Site 0148) — Louisville, Kentucky, United States
• Velocity Clinical Research, Lafayette ( Site 0103) — Lafayette, Louisiana, United States
• Velocity Clinical Research, Gulfport ( Site 0115) — Gulfport, Mississippi, United States
• Velocity Clinical Research, Hastings ( Site 0114) — Hastings, Nebraska, United States
• Midwest Children's Health Research Institute ( Site 0117) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute ( Site 0106) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute-Research ( Site 0119) — Lincoln, Nebraska, United States
• Midwest Children's Health Research Institute-Research ( Site 0102) — Lincoln, Nebraska, United States
• Velocity Clinical Research, Albuquerque ( Site 0112) — Albuquerque, New Mexico, United States
• Velocity Clinical Research, Vestal ( Site 0121) — Vestal, New York, United States
• Epic Medical Research - Oklahoma ( Site 0134) — Chickasha, Oklahoma, United States
• Tribe Clinical Research, LLC-Pediatrics ( Site 0118) — Greenville, South Carolina, United States
• Tribe Clinical Research - Spartanburg ( Site 0108) — Spartanburg, South Carolina, United States
• Velocity Clinical Research, Austin ( Site 0129) — Austin, Texas, United States
• PanAmerican Clinical Research ( Site 0132) — Brownsville, Texas, United States
• Central Research Associates ( Site 0145) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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