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

A Phase IIb, Randomized, Observer-Blind study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

Date Added
October 23rd, 2025
PRO Number
Pro00146601
Researcher
Robert Clifford

List of Studies


Keywords
Adolescents, Vaccine
Summary

A germ (bacterium) called meningococcus, or Neisseria meningitidis, can cause several serious diseases, including meningitis and blood infection. Meningitis affects the brain and spinal cord. It can cause hearing loss, seizures, learning and behavior problems, severe brain damage and even death. Meningitis can happen to anyone but is more common in teenagers and young children, including babies. This research study will help us learn about vaccines that protect against diseases caused by different types of meningococcus germs: types A, B, C, W, Y.

This study is being conducted to learn more about the safety and immune response of the study vaccine MenABCWY when 2 doses are given 24 months apart (0,24-month schedule) or 48 months apart (0,48-month schedule). The study will be conducted in healthy adolescents from 11 to 14 years of age.

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

A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE

Date Added
September 16th, 2025
PRO Number
Pro00146400
Researcher
Stephen Stripling

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

This is a Phase 2, multicenter, randomized, partially double-blind study to evaluate the safety, tolerability, and immunogenicity of PG4 in healthy toddlers 12 through 15 months of age who previously received 3 infant doses of 20vPnC. This study will be conducted at investigator sites in the US and Puerto Rico. Approximately 225 children between 12 and 15 months of age will be enrolled and randomized in a 2:2:1 ratio by site-based randomization to receive either 1 or 2 doses of PG4 (90 participants per group) or 1 dose of the control vaccine 20vPnC (45 participants). The vaccine in toddlers randomized to receive 1 dose will be double-blind, as PG4 and 20vPnC have the same appearance and a single dose will be administered at Visit 101 of the study. For participants randomized to 2 doses of PG4, the parents/legal guardians and site staff will know that these participants will need to return for a second vaccination visit and that they will receive PG4 at both Visit 201 and Visit 202.

Institution
MUSC
Recruitment Contact
Meghan Armistead
8434736623
mea301@musc.edu

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)

Date Added
October 18th, 2016
PRO Number
Pro00059616
Researcher
Bhavadharini Ramu

List of Studies


Keywords
Cardiovascular, Heart, Vaccine
Summary

INVESTED is a multi-site trial comparing high-dose (60 μg per vaccine viral strain) trivalent influenza vaccine to standard-dose (15 μg per viral strain) quadrivalent influenza vaccination for up to three influenza seasons in high-risk cardiovascular disease patients with a history of myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months. Subjects will be randomly assigned to receive either the high-dose or standard-dose vaccine.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu



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