Phase 3
Completed N=598
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Source: ClinicalTrials.gov NCT00822237 ↗Enrolled (actual)
598
Serious AEs
0.3%
Results posted
Apr 2011
Primary outcomePrimary: Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). — 96.3 Percent of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). |
96.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is in good health based on medical history
- Subject has no history of measles, mumps, rubella, chickenpox, or shingles
Exclusion Criteria
- Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
- Subject has history of immune disorders
- Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
- Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
- Subject has received a live vaccine within 30 days of first dose of study vaccine
- Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
- Subject has had a fever within 72 hours of study start
Data sourced from ClinicalTrials.gov (NCT00822237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.