drugset / Trial / NCT04525599

A Study to Assess the Safety, Tolerability and Immunogenicity of ASP3772, a Pneumococcal Vaccine, in Toddlers 12 to 15 Months of Age in Comparison to an Active Comparator

NCT04525599

Phase 1 Completed 75 enrolled Affinivax, Inc.
RandomizedSequentialDouble-blindPrevention

Summary

The purpose of this study is to evaluate the safety and tolerability of three dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in toddlers who have previously been administered the routine three-dose series of PCV13. This study will also evaluate the immunogenicity (production of an immune response) of three different dose levels of ASP3772 in comparison to the active comparator PCV13 in toddlers who have previously been administered the routine three-dose series of PCV13.

Timeline

Start
2020-09-22
Primary completion
2022-04-06
Completion
2022-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ASP3772 Vaccine Intramuscular
Comparator Prevnar 13 Vaccine Intramuscular