CTRI/2012/07/002757尚未招募3 期
An Open label evaluation of Immunogenicity and Safety of Biovac-A Freeze Dried, Live Attenuated Hepatitis-A Vaccine in healthy children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy children of either sex between the age range of 1-12 years.
- •2. Subjects at baseline with negative HAV antibodies (Anti HAV antibodies level £ 20
- •3. Subjects whose parents/guardians are willing to give written â??Informed Consent Form.â??
排除标准
- •1. Known hypersensitivity to the vaccine or any component of the vaccine.
- •2. Previous history of Hepatitis A infection and subsequent jaundice manifested due to the infection.
- •3. Subjects who have earlier received even a single dose of hepatitis A vaccine.
- •4. Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease.
- •5. Subjects suffering from acute febrile illness.
- •6. Subjects with a present or past history of allergic reactions.
- •7. Subjects with clinically significant abnormal hematological and/or biochemical investigations.
- •8. Subjects who have participated in an investigational study within the past 2 weeks.
- •9. Subjects currently receiving immunosuppressant drugs.
- •10. Subjects whose parents/guardians are unwilling to give written â??Informed Consent Formâ??.
研究者
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