CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugatebiological
Likely dose
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02591290
NCT02591290Phase 4Completed
CompareCT.gov

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

Sanofi Pasteur, a Sanofi Company·interventional·Posted Oct 29, 2015·Updated Nov 6, 2017

In Brief

A Phase 4 clinical trial evaluating Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate for Meningitis and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningitis, Meningococcal Meningitis, Meningococcal Infections
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 29, 2015
Enrollment StartOct 20, 2015
Primary CompletionMar 16, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.7 years ago

Interventions

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugatebiological

0.5 mL, Intramuscular (2 doses with 8-week interval)