Trials / Completed
CompletedNCT00822237
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 598 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 12 Months – 23 Months
- Healthy volunteers
- Accepted
Summary
This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.
Detailed description
This treatment has been approved for sale to the public.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Varicella Virus Vaccine Live (2007 Process) (Oka/Merck) | VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart |
| BIOLOGICAL | Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck) | VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart |
| BIOLOGICAL | Measles, Mumps, and Rubella Virus Vaccine Live (MMR) | M-M-R II in two 0.5 mL doses by injection \~6 weeks apart |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2009-10-01
- Completion
- 2009-12-01
- First posted
- 2009-01-14
- Last updated
- 2017-04-12
- Results posted
- 2011-04-21
Source: ClinicalTrials.gov record NCT00822237. Inclusion in this directory is not an endorsement.