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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01077804
Other study ID # V210-036
Secondary ID 2010_014EP08005.
Status Completed
Phase N/A
First received February 26, 2010
Last updated October 22, 2015
Start date June 1995
Est. completion date November 2010

Study information

Verified date October 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7585
Est. completion date November 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 23 Months
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp. Kaiser Permanente

References & Publications (1)

Guess HA, Broughton DD, Melton LJ 3rd, Kurland LT. Population-based studies of varicella complications. Pediatrics. 1986 Oct;78(4 Pt 2):723-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary 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 No
Secondary Incidence Rate of Herpes Zoster Infection Herpes zoster cases were physician-diagnosed. From 6 weeks to 168 months (14 years) post vaccination No
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