N/A
N=7,585
A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
Varicella · Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT01077804 ↗Enrolled (actual)
7,585
Serious AEs
—
Results posted
Nov 2011
Primary outcome: Primary: Number of Participants With an Occurrence of Breakthrough Varicella — 1425; 362; 28 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Occurrence of Breakthrough Varicella |
1425; 362; 28 | — |
| PRIMARY Incidence Rate of Breakthrough Varicella |
15.9; 4; 0.3 | — |
| SECONDARY Number of Participants With an Occurrence of Herpes Zoster Infection |
46 | — |
| SECONDARY Incidence Rate of Herpes Zoster Infection |
0.45 | — |
Summary
The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.
Eligibility Criteria
Inclusion Criteria
- Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up
Exclusion Criteria
- Subjects diagnosed with varicella before study enrollment
- Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
Data sourced from ClinicalTrials.gov (NCT01077804). 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.