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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Varicella; Herpes Zoster

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01077804

V210-036

2010_014 (Other Identifier)

EP08005.002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7,585 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

7,585 participants in 1 patient group

Varivax vaccinated children

Description:

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.