Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432731
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2007-02-07
Brief Title:
Safety Study of a Refrigerator-stable Formulation of VARIVAX
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Double-blind Randomised Controlled Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX in Healthy 12 to 15 Month-old Infants
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Primary objective
To describe the safety profile of a refrigerator-stable formulation of VARIVAX as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination
Secondary objectives NA
To describe the safety profile of a refrigerator-stable formulation of VARIVAX as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination
Secondary objectives NA
Detailed Description:
None
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 |
|---|---|---|---|
| X04-VAR-402 | OTHER | MCMVaccBV SPMSD Secondary ID | None |