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

Herpes Zoster Clinical Trial

Official title:

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

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

• Herpes Zoster
• Varicella

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