Ignite Creation Date:
2024-05-06 @ 7:45 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02591290
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2015-10-27
Brief Title:
Immunogenicity and Safety of Two-Dose Series of Menactra in Japanese Healthy Adult Subjects
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 AC 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
Primary Objective
To evaluate and describe the immune responses to meningococcal antigens serogroups AC 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1174-4291 | OTHER | WHO | None |