A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Health Infants.

Date Added
July 31st, 2026
PRO Number
Pro00149890
Researcher
Stephen Stripling

List of Studies

Keywords
Healthy Volunteer Studies, Pediatrics, Vaccine
Summary

A germ called Streptococcus pneumoniae (also known as S pneumoniae) is a leading cause of serious diseases including infection of the lungs (pneumonia), infection of the brain lining (meningitis), infection of the blood (bacteremia) and infection of the ears (otitis). There are more than 90 different types of S pneumoniae, some of which cause more serious infections than others. 20-valent (meaning the vaccine protects against 20 different types of S. pneumoniae) pneumococcal conjugate vaccine (Prevnar 20®; 20vPnC) was approved in 2021 first in adults then in children in the United States in 2023, to prevent pneumococcal disease.

The study vaccine, 25-valent pneumococcal conjugate vaccine (25vPnC, PG4 vaccine, pneumococcal fourth-generation vaccine) contains the same components found in 20vPnC, one of which has been changed, but with 5 additional components to help expand protection against 25 types of S pneumoniae. The study vaccine is not approved by the United States Food and Drug Administration (FDA) or elsewhere around the world.

This study will look at how a new pneumococcal vaccine will work in healthy infants while expanding protection against pneumococcal disease due to the germ called S pneumoniae; and, how the new study pneumococcal vaccine will work together with recommended childhood shots.

This study will last for about 16 to 19 months and will have at least 6 visits and 1 telephone contact, about 6 months after your child's last study vaccination.

Institution
MUSC
Recruitment Contact
Jasmine Dewitt
(843) 305-5798
dewitjas@musc.edu

Finding Their Voice: Youth Perspectives on Optional Vaccination Decisions

Date Added
June 23rd, 2026
PRO Number
Pro00151683
Researcher
Sharon Smith

List of Studies

Keywords
Vaccine
Summary

Youth participation in healthcare is becoming more prevalent, and outcomes are improved when youth have a voice in decisions. Little is known about how much adolescents participate in decision-making about vaccinations including "optional" vaccines or those not required for school attendance. This is a survey to evaluate the extent to which adolescents were involved in the decision to be vaccinated for 4 common vaccines: FLU (influenza), COVID (SARS-CoV-2 virus), MEN (meningococcemia), and HPV (Human Papilloma Virus).

Institution
MUSC
Recruitment Contact
Sharon Smith
843-792-2300
smsharon@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

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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