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临床试验/NCT01782794
NCT01782794已完成不适用

Measurement of the Changes in Hepatitis B Immunization Coverage in Infants, and the Acceptability Thereof, Before Reimbursement, Then During the Three Years After Reimbursement of InfanrixHexa® in France, Among the General Population

GlaxoSmithKline0 个研究点目标入组 2,413 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,413
主要终点
Proportion of infants receiving Hepatitis B vaccination.

研究概览

简要总结

The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general population before and after reimbursement of the paediatric vaccine InfanrixHexa. Four measurements are planned, first before reimbursement and the others at year 1, 2 and 3 after reimbursement.

详细描述

The present study aims to evaluate the changes in Hepatitis B immunization coverage and the acceptability thereof among parents, in the general population. This is a national, prospective, epidemiological study, comprising four measurement time-points over a three-year period, (T1 in 2009, T2 in 2010, T3 in 2011, and T4 in 2012) in order to cover the period prior to the introduction of InfanrixHexa® reimbursement, the transition period, and the period following reimbursement of the vaccine. The periods between each data collection time-point will be identical, lasting a year. Two age groups will be investigated at each data collection time-point: 12-15 months and 24-27 months, thus providing measurements before/after reimbursement.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Cross Sectional

入排标准

年龄范围
12 Months 至 27 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants aged 12 to 15 months or 24 to 27 months inclusive at the time of the study.
  • With a parent or legal representative agreeing to take part in the interview.
  • Residing in metropolitan France.

排除标准

  • Refusal to take part.
  • Infants having lived in another country in their first two years of life.

结局指标

主要结局

Proportion of infants receiving Hepatitis B vaccination.

时间窗: 4 years

次要结局

  • Evaluation of the immunization coverage levels by other vaccines.(4 years)
  • Acceptability of vaccinating against Hepatitis B.(4 Years)

研究者

申办方类型
Industry
责任方
Sponsor

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