Phase 3
Completed N=22,439
Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
Source: ClinicalTrials.gov NCT00534248 ↗Enrolled (actual)
22,439
Serious AEs
2.1%
Results posted
May 2011
Primary outcomePrimary: Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group — 1.994; 6.596 number of HZ cases/1000 person-years — p=<.001
Summary
This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group |
1.994; 6.596 | <.001 sig |
| SECONDARY Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group |
660.0; 293.1 | <.001 sig |
| SECONDARY Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period |
69; 61 | — |
Eligibility Criteria
Inclusion Criteria
- Must be between 50 - 59 years of age
- No fever on day of vaccination
- Females of reproductive potential must be willing to use acceptable form of birth control
Exclusion Criteria
- Have received chicken pox or shingles vaccine
- Have already had shingles
- Have recently had another vaccination
- Pregnant or breast feeding. Have participated in another research study in the last 30 days
- You are taking certain antiviral drugs
- History of allergic reaction to any vaccine component, including gelatin or neomycin
Data sourced from ClinicalTrials.gov (NCT00534248). 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.