NCT00169858已完成4 期
Open Randomised Clinical Study of the Long Term Immunogenicity of Engerix-B in 10 Year Old Children and of the Effect of Booster Injections Given 5, 10 or 15 Years After Primary Vaccination
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,129
- 试验地点
- 1
- 主要终点
- To evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.
研究概览
简要总结
Hepatitis B immunization has been offered to all grade 4 students (age 9-10) in the province of Quebec, using Engerix-B at a dose of 10 mkg. The peak incidence of hepatitis B occurs between age 15 and 35; the proportion of vaccinated children who will still be protected at this age is currently unknown. This study is designed to determine:
- persistence of immunity until age 25
- persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
- the effect of a booster dose on immunogenicity at either 5, 10 or 15 years after the primary vaccination course (at age (15, 20 or 25).
详细描述
Three doses of Engerix-B vaccine (10 mkg) were administered according to 0, 1, 6 month schedule to 1126 9-10 year-old children.
The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.
Secondary objectives
- To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
- To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)
- To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)
- To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)
- To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)
- To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects (Group C)
- To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
- To evaluate safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
- •Must be HBc negative
- •Required standard interval between last dose of primary immunization and booster vaccination
- •Written informed consent obtained from the subject
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study
- •Previously completed routine childhood vaccination to the best of his/her knowledge
- •If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.
排除标准
- •- Not applicable
结局指标
主要结局
To evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection.
时间窗: 1995 - 2011
Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination.
次要结局
- - To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert(1 month post primary vaccination)
- - To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A)(2001)
- - To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A)(2001)
- - To determine the antibody levels of subjects in groups A and B at age 20, 5 years after booster (Group A), 10 years after primary vaccination (Group B)(2006)
- - To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B)(2006)
- - To determine the persistence of antibody 15 years after primary vaccination (Group C)(2011)
- - To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster(2011)
- - To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C)(2011)
研究者
研究点 (1)
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