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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
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.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 695 |
| Start date | 2003-10 |
| Completion | 2004-06 |
Conditions
- Healthy
Interventions
- Comparator: Varicella Zoster Virus Vaccine
- Comparator: Varicella Zoster Virus Vaccine
Primary outcomes
- Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) — Day 1-42 post vaccination
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level. - Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) — Day 1-5 postvaccination