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

Recruiting
2 - 17 years of age
Both
Phase 3

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Overview

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).

Eligibility

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

Study details

Pneumococcal Infection

NCT06177912

Merck Sharp & Dohme LLC

24 June 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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