Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)
Phase 3
Completed
- Conditions
- Healthy
- Registration Number
- NCT00092417
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 695
Inclusion Criteria
- Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster
Exclusion Criteria :
- Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method