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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
695
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\~207,000 plaque-forming units \[PFU\]/0.65-mL dose)
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (\~58,000 plaque-forming units \[PFU\]/0.65-mL dose)
Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
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.
Time frame: Day 1-42 post vaccination
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Time frame: Day 1-5 postvaccination
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