Trials / Completed
CompletedNCT00432731
Safety Study of a Refrigerator-stable Formulation of VARIVAX®
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 500 (planned)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 15 Months
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VARIVAX® | |
| BIOLOGICAL | M-M-RTM II |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2005-09-01
- Completion
- 2005-09-01
- First posted
- 2007-02-08
- Last updated
- 2017-03-14
Locations
25 sites across 2 countries: France, Italy
Source: ClinicalTrials.gov record NCT00432731. Inclusion in this directory is not an endorsement.