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Completed

NCT Number: NCT01077804

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

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.

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Key information

Conditions

Varicella Chickenpox DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–23 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Participants With an Occurrence of Breakthrough Varicella

    Time frame: 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.

  2. Incidence Rate of Breakthrough Varicella

    Time frame: 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 outcomes

  1. Number of Participants With an Occurrence of Herpes Zoster Infection

    Time frame: From 6 weeks to 168 months (14 years) post vaccination

    Herpes zoster cases were physician-diagnosed cases.

  2. Incidence Rate of Herpes Zoster Infection

    Time frame: From 6 weeks to 168 months (14 years) post vaccination

    Herpes zoster cases were physician-diagnosed.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2010
Study completion
2010
First posted
Mar 1, 2010
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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