At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 695 enrolled
Drug / intervention
Comparator: Varicella Zoster Virus Vaccine +1 morebiological
Likely dose
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)AI-extracted
Key inclusion· 3
- ✓Age 50 years or older
- ✓History of chickenpox
- ✓No prior herpes zoster infection
Key exclusion· 1
- ✕Preexisting conditions that inhibit immune response
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older
In Brief
A Phase 3 clinical trial evaluating Comparator: Varicella Zoster Virus Vaccine for Healthy. Completed, enrolled 695 participants.
Detailed Summary
This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
Primary CompletionJun 2004
First PostedSep 2004
TodayJul 2026
First PostedSep 27, 2004
Enrollment StartOct 1, 2003
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 21.8 years ago
Interventions
Comparator: Varicella Zoster Virus Vaccinebiological
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\~207,000 plaque-forming units \[PFU\]/0.65-mL dose)
Comparator: Varicella Zoster Virus Vaccinebiological
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (\~58,000 plaque-forming units \[PFU\]/0.65-mL dose)