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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077804
First received: February 26, 2010
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Varicella
Herpes Zoster

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants With an Occurrence of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]
    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.

  • Incidence Rate of Breakthrough Varicella [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]
    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:
  • Number of Participants With an Occurrence of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]
    Herpes zoster cases were physician-diagnosed cases.

  • Incidence Rate of Herpes Zoster Infection [ Time Frame: From 6 weeks to 168 months (14 years) post vaccination ] [ Designated as safety issue: No ]
    Herpes zoster cases were physician-diagnosed.


Enrollment: 7585
Study Start Date: June 1995
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Varivax vaccinated children
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.

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.

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

15 years prospective follow-up of the original study cohort

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077804

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Kaiser Permanente
Investigators
Principal Investigator: Roger Baxter Kaiser Permanente Vaccine Study Center
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077804     History of Changes
Other Study ID Numbers: V210-036, 2010_014, EP08005.002
Study First Received: February 26, 2010
Results First Received: September 29, 2011
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014