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

Completed

• Conditions: Varicella; Herpes Zoster

• Registration Number: NCT01077804
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 1995-06-01
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2010-09-01
• Study Completion: 2010-11-01
• Results First Submitted: 2011-09-29
• Results First Submitted QC: 2011-09-29
• Results First Posted: 2011-11-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7585

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Breakthrough Varicella	From 6 weeks to 168 months (14 years) post vaccination	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.
Number of Participants With an Occurrence of Breakthrough Varicella	From 6 weeks to 168 months (14 years) post vaccination	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.

Secondary Outcome Measures

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