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

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ClinicalTrials.gov Identifier: NCT01077804
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : November 3, 2011
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease
Varicella 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 Type : Observational
Actual Enrollment : 7585 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents
Actual Study Start Date : June 1, 1995
Actual Primary Completion Date : September 1, 2010
Actual Study Completion Date : November 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles
U.S. FDA Resources

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   12 Months to 23 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077804


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077804     History of Changes
Other Study ID Numbers: V210-036
2010_014 ( Other Identifier: Merck )
EP08005.002 ( Other Identifier: Merck )
First Posted: March 1, 2010    Key Record Dates
Results First Posted: November 3, 2011
Last Update Posted: September 15, 2017
Last Verified: August 2017

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