Study

Overview

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 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).

Study Type:

Interventional

Study Phase:

Phase 3

Enrollment:

882

Study Start Date:

January 2024

Study Completion Date:

February 2025

Primary Completion Date:

February 2025

Eligibility

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:

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.

Locations

No Contacts or Locations in US/Canada Provided

Results

Click here to access ClinicalTrials.gov site to view results.

Clinical Study Reports

Synopsis V116-013

Study Detail

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

Overview

Eligibility

CRITERIA

Locations

Results