A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)

Study Overview
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Brief Summary
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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.

Detailed Description
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Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.

Official Title
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Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents

Conditions
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Varicella, Herpes Zoster

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Varivax vaccinated children<br>Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Occurrence of Breakthrough Varicella | Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required. | From 6 weeks to 168 months (14 years) post vaccination | 
| Incidence Rate of Breakthrough Varicella | Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with any symptoms) were reported by parents during the interview. No medical confirmation of the diagnosis was required. | From 6 weeks to 168 months (14 years) post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Occurrence of Herpes Zoster Infection | Herpes zoster cases were physician-diagnosed cases. | From 6 weeks to 168 months (14 years) post vaccination | 
| Incidence Rate of Herpes Zoster Infection | Herpes zoster cases were physician-diagnosed. | From 6 weeks to 168 months (14 years) post vaccination |