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

ClinicalTrials.gov Identifier: NCT06177912 (view full study on clinicaltrials.gov)
Condition:  Pneumococcal Infection
Status:  Recruiting


Official Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease

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).

Study Type:
Interventional
Study Phase:
Phase 3
Estimated Enrollment:
820
Study Start Date:
January 2024
Estimated Study Completion Date:
February 2025
Estimated Primary Completion Date:
February 2025
Ages Eligible for Study:
2 years to 17 years
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
No


CRITERIA

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

United States     Toll Free Number     1-800-770-4674   

  • Birmingham, Alabama, 35205
  • Phoenix, Arizona, 85006
  • Madera, California, 93637
  • Colorado Springs, Colorado, 80922
  • Orlando, Florida, 32829
  • Macon, Georgia, 31210
  • Idaho Falls, Idaho, 83404
  • Rexburg, Idaho, 83440
  • Gulfport, Mississippi, 39503
  • Lincoln, Nebraska, 68504
  • Lincoln, Nebraska, 68505
  • Lincoln, Nebraska, 68516
  • Lincoln, Nebraska, 68522
  • Albuquerque, New Mexico, 87107
  • Vestal, New York, 13850
  • Chickasha, Oklahoma, 73018
  • Greenville, South Carolina, 29607
  • Spartanburg, South Carolina, 29301
  • Austin, Texas, 78759
  • Brownsville, Texas, 78521
  • Desoto, Texas, 75115
  • Mesquite, Texas, 75150
  • Layton, Utah, 84041
  • West Jordan, Utah, 84088

Canada     Study Coordinator     9055451376212   

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