Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392808
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2006-10-25
Brief Title:
Immunogenicity of the Booster Dose of Two MenC Vaccines
Sponsor:
Centro Superior de Investigación en Salud Publica
Organization:
Centro Superior de Investigación en Salud Publica
Study Overview
Official Title:
Randomized Open Label Active Control Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life
Status:
COMPLETED
Status Verified Date:
2013-08
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:
CSISP-MENC1
Brief Summary:
The purpose of the study is to evaluate the immune response of toddlers to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine and to assess the interchangeability of the two different vaccines
Detailed Description:
Children 14 to 18 months of life previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age are randomized to receive any of the two vaccines Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose Children will also be vaccinated with a combined vaccine containing DTaPIPVHib
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 |
|---|---|---|---|
| EUDRA 2006-003525-82 | None | None | None |