Phase 3
Completed N=698
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)
Healthy
Source: ClinicalTrials.gov NCT00092417 ↗
Enrolled (actual)
698
Serious AEs
0.7%
Results posted
Jun 2010
Primary outcomePrimary: Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) — 0; 0; 459; 234 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) |
0; 0; 459; 234 | — |
| PRIMARY Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) |
79; 21; 380; 213 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00092417). 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.