Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01430611
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2011-09-06
Brief Title:
Study of Sanofi Pasteur and Lanzhou Institutes Meningococcal Group A and C Polysaccharide Vaccine in Children
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Safety and Immunogenicity of Sanofi Pasteur Meningococcal Groups A and C Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal Groups A and C Polysaccharide Vaccine in Children 2-6 Years of Age in China
Status:
COMPLETED
Status Verified Date:
2014-04
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:
This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo AC vaccine in healthy Chinese children 2 to 6 years of age
Primary Objective
To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C 30 days after a single dose of Sanofi Pasteur Meningococcal Groups A and C Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal Groups A and C Polysaccharide Vaccine
Secondary Objective
To describe the immunogenicity for serogroups A and C 30 days after administration of the study vaccines given as a single dose
To describe the full reactogenicity profile after administration of the study vaccines given as a single dose
Primary Objective
To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C 30 days after a single dose of Sanofi Pasteur Meningococcal Groups A and C Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal Groups A and C Polysaccharide Vaccine
Secondary Objective
To describe the immunogenicity for serogroups A and C 30 days after administration of the study vaccines given as a single dose
To describe the full reactogenicity profile after administration of the study vaccines given as a single dose
Detailed Description:
Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal Groups A and C Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal Groups A and C Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1120-1190 | OTHER | WHO | None |