drugset / Trial / NCT02591290
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Menactra | Vaccine | 0.5 ml | Intramuscular |