A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents age 6 to <18 Years of Age with Functional Constipation (FC)

Date Added
August 28th, 2026
PRO Number
Pro00150394
Researcher
Robert Clifford

List of Studies


Keywords
Bowel, Children's Health, Pediatrics, Stomach
Summary

This is a randomized, double-blind, placebo-controlled, multicenter, parallel-group
study of the efficacy and safety of 2 weight-based treatment groups of plecanatide
versus placebo in children and adolescent participants 6 to less than 18 years of age with FC. Randomization will be stratified by sex to ensure balance across treatment groups.

Approximately 30 participants will be randomized to each of the Placebo, Low
Dose, and High Dose groups, within age group. Low Dose and High Dose will be
assigned once daily treatments based on the weight of the participant at
randomization to achieve weight-based dosing of 0.025 to 0.05 mg/kg in the Low
Dose treatment group and 0.05 to 0.1 mg/kg in the High Dose treatment group.

Institution
MUSC
Recruitment Contact
Matthew Bird
8438702225
birdma@musc.edu

A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children

Date Added
August 21st, 2026
PRO Number
Pro00147750
Researcher
Robert Clifford

List of Studies


Keywords
Children's Health, Vaccine
Summary

This trial is testing V118C in infants and toddlers.

V118C is an experimental vaccine. Vaccines help to prevent illness by teaching the body's immune system how to fight infections. The immune system is a network of organs and cells that fight infections. If it works, V118C may prevent an illness called pneumococcal disease. This is an illness caused by certain germs. These germs can cause infections, some of which may be serious, in the ears, nose, lungs, blood, or brain.

This trial will compare V118C to a vaccine called PCV20. PCV20 is approved to prevent pneumococcal disease in infants and toddlers.

Institution
MUSC
Recruitment Contact
Matthew Thomas
8438702225
thommatt@musc.edu

A PHASE IIIb MULTICENTER, SINGLE-ARM, OPEN-LABEL SURVEILLANCE STUDY OF SUSCEPTIBILITY TO BALOXAVIR MARBOXIL IN PATIENTS WITH INFLUENZA

Date Added
March 31st, 2026
PRO Number
Pro00146625
Researcher
Robert Clifford

List of Studies


Keywords
Children's Health, Drug Studies, Pediatrics
Summary

The flu is caused by a virus that can sometimes change. This can make the flu resistant to treatment, which means drugs, like baloxavir marboxil, can become less effective for treating the flu (also known as "resistance").

The purpose of this study is to monitor changes in the flu virus before and after study treatment with baloxavir marboxil in children. The resistance of the flu virus to study treatment with baloxavir marboxil will also be monitored.

Institution
MUSC
Recruitment Contact
Jasmine Dewitt
843-870-2225
dewitjas@musc.edu

A Phase 3a, observer-blind, randomized, controlled study to demonstrate lot-to-lot consistency and evaluate the immunogenicity and safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age

Date Added
February 10th, 2026
PRO Number
Pro00145276
Researcher
Robert Clifford

List of Studies


Keywords
Adolescents, Children's Health, Pediatrics, Vaccine
Summary

The investigational varicella vaccine (hereafter referred to as VNS vaccine) is a new
candidate varicella vaccine derived from the Oka strain. The main rationale for the
development of VNS vaccine is to provide an additional alternative varicella vaccine as an advantage from a public health perspective to prevent varicella disease

Institution
MUSC
Recruitment Contact
Amelia Gaines
843-284-4254
gaineame@musc.edu



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