Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Immunogenicity
研究概览
简要总结
The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
详细描述
In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.
this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 19 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Comparator group :
- •have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.
- •Study groups:
- •have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.
排除标准
- •Have received other doses of hepatitis B vaccine;
- •Be considered immunosuppressed;
- •Have an autoimmune disease;
- •Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
- •Have a bleeding disorder;
- •Be significantly delayed in development;
- •Have or plan to participate in other clinical studies with vaccines or products not approved in Canada;
- •Have presented a serious clinical condition to the vaccines administered as part of the study.
研究组 & 干预措施
Infanrix-hexa+Infanrix-hexa+Infanrix-hexa
Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa
干预措施: Infanrix-hexa, Twinrix-Junior (Biological)
Infanrix-hexa+Infanrix-hexa
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa
干预措施: Infanrix-hexa, Twinrix-Junior (Biological)
Infanrix-hexa+Twinrix
Children vaccinated at the age of 2 and 18 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively
干预措施: Infanrix-hexa, Twinrix-Junior (Biological)
结局指标
主要结局
Immunogenicity
时间窗: 1 month post last dose of vaccine
The proportion of children with an anti-HBs titer ≥10mIU/ml
次要结局
- Immune memory(36 months post last primary vaccine dose)