NCT02591290

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular (2 doses with 8-week interval)

Timeline

• Start date: 2015-10-20
• Primary completion: 2016-03-16
• Completion: 2016-03-16
• First posted: 2015-10-29
• Last updated: 2017-11-06
• Results posted: 2017-11-06

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study