EUCTR2006-001638-42-NO进行中（未招募）1 期
Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age - Hepatitis B Vaccine (Recombinant) Infant Dose Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,718
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Healthy male and female infants ~2 months of age (40 to 80 days).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or another known carrier of hepatitis B virus ever living in close contact with the subject.
- •2. Birth mother, during the course of this pregnancy, did not receive any prenatal care.
- •3. Previous history of hepatitis B infection.
- •4. Known or suspected impairment of immunologic function or prior use (defined as 14 days prior to study start) of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
- •5. Prior vaccination with any hepatitis B vaccine for infant or mother (within 6 months prior to birth of child).
- •6. Recent (<72 hours) history of febrile illness ³99.5°F (³37.5°C) axillary or ³100.5°F (³38.1°C), rectal temperature.
- •7. Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product in the subject, or receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the child.
- •8. Any prior receipt of investigational drugs or other investigational vaccines by the infant since birth or by the mother if breastfeeding within 14 days prior to first injection with the study vaccine or if scheduled to be given to the infant during the study.
- •9. Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast).
- •10. Any infant who cannot be adequately followed for study visits during the course of the clinical study.
- •11. Any condition that in the opinion of the investigator may interfere with the evaluation of the study objectives.
研究者
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