Meningitis Clinical Trial
Official title:
Immunogenicity and Safety of Two-Dose Series of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284; Menactra®) in Japanese Healthy Adult Subjects
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.
All participants received a 2-dose series of the study vaccine with 8-week interval and was monitored for safety and assessed for immunogenicity at baseline (pre-vaccination) and at 28 to 35 days following each vaccination. ;
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