Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,585
- 主要终点
- Incidence Rate of Breakthrough Varicella
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Subjects diagnosed with varicella before study enrollment
- •Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
结局指标
主要结局
Incidence Rate of Breakthrough Varicella
时间窗: 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.
Number of Participants With an Occurrence of Breakthrough Varicella
时间窗: 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.
次要结局
- Number of Participants With an Occurrence of Herpes Zoster Infection(From 6 weeks to 168 months (14 years) post vaccination)
- Incidence Rate of Herpes Zoster Infection(From 6 weeks to 168 months (14 years) post vaccination)