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

The purpose of this Phase 3 pivotal pediatric study is to evaluate the safety, tolerability, and immunogenicity of the PG4 vaccine in infants receiving a 4-dose series of the PG4 vaccine or 20vPnC. Data will also be generated on key co-administered, routine pediatric vaccines given with the PG4 vaccine or 20vPnC. This study is intended for licensure in multiple countries. The study objectives and endpoints have been informed by criteria specific to the health authorities to whom the data may be submitted.

Study ID: 5748
NCT Number: 07629440
Principal Investigator: Amruta Padhye, MD
Department: Pediatrics-Infectious Disease
Eligibility: Both men and women 1 year old to 2 years old. Accepts healthy volunteers.

For questions about this study, please contact:

ClinicalTrialsInterest@health.missouri.edu
(573) 882-7026