Research Study

Menveo Post-Licensure Safety Study in Individuals 2-10 and 11-21 Years of Age

This study will fulfill a post-marketing commitment between Novartis Vaccines and Diagnostics and the FDA to expand the safety profile of this vaccine in this age group. This is an observational study and is expected to span multiple years within KPSC. Subjects will be immunized with Menveo as part of their routine care. Subjects who have been vaccinated with Menveo and have experienced an event of interest during the first year are selected for analysis; and subjects are selected for analysis using the SCCS methodology, which sums the occurrence of events that fall within a risk window and those that do not fall within these windows.

Principal Investigator:

Hung Fu Tseng, PhD, MPH

Funding Source:

Novartis Pharmaceuticals Corporation

Funding Years:

2011 - 2018