Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311415
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2006-04-03
Brief Title:
Immunogenicity Safety Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children
Sponsor:
Novartis Vaccines
Organization:
Novartis
Study Overview
Official Title:
A Phase III Multi-Center Open-Label Controlled Randomized Study to Evaluate the Immunogenicity Safety Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age With a Booster at 12-16 Months of Age in Comparison to Two Doses in the First Year of Life Given Two Months Apart With a Booster at 12-16 Months of Age and in Comparison to One Dose Given at 12-16 Months of Age
Status:
COMPLETED
Status Verified Date:
2012-02
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:
Immunogenicity Safety Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children
Detailed Description:
The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life 2 doses in the first year of life given 2 months apart at 2 and 4 months of age with a booster in the second year of life or 1 dose in the first year of life at 2 or 6 months of age with a booster in the second year of life or only 1 dose in the second year of life
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 |
|---|---|---|---|
| Impact N 919 | None | None | None |