drugset / Trial / NCT02591290

Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects

NCT02591290

Phase 4 Completed 60 enrolled Sanofi Pasteur, a Sanofi Company
NaSingle-groupOpen-labelPrevention

Summary

The aim of this study was to collect further information regarding an increase immune response of SP284 after an additional dose in Japanese participants. Primary Objective: * To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C, Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20 through 55 years of age. Other Pre-specified objective: * To describe the safety in terms of immediate systemic adverse events (AEs), solicited reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs) following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.

Timeline

Start
2015-10-20
Primary completion
2016-03-16
Completion
2016-03-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Menactra Vaccine 0.5 ml Intramuscular