EUCTR2006-003648-46-FI进行中（未招募）1 期
A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity ofHaemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a ModifiedProcess - Healthy Infant 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
- 546
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
- 性别
- All
入选标准
- •Healthy 2-month-old infants (40 to 80 days of age) born to mothers who are not carriers of hepatitis B surface antigen (HbsAg seronegative).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of previous hepatitis B infection or invasive Hib disease. This includes the birth mother of the subject. Subjects with mothers known to be a carrier of hepatitis B surface antigen (HBsAg seropositive) or subjects ever living in close contact with a known carrier may not be enrolled.
- •2.Prior vaccination with any hepatitis B vaccine or Hib vaccine for subject (or for mother within 6 months prior to birth of infant).
- •3.Birth mother who did not receive prenatal care during the course of this pregnancy.
- •4.Recent (<72 hours) history of febrile illness (rectal temperature =38.1°C [=100.5°F]).
- •5.Prior vaccination with Prevenar™ or any pneumococcal vaccine.
- •6.Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ (e.g., aluminum, yeast), Pedvax HIB™, or COMVAX™ (e.g., yeast).
- •7.Known or suspected hypersensitivity to any component of Prevenar™ (e.g., diphtheria toxoid).
- •8.Administration since birth of: hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product (e.g., blood transfusion) to subject or receipt by mother within 6 months prior to birth of infant (or if scheduled during the study period).
- •9.Receipt of any live virus vaccine within 4 weeks prior to immunization.
- •10.Prior receipt of investigational drugs or vaccines since birth or if scheduled to be given during the study or receipt by the mother if breastfeeding within 14 days prior to Dose 1.
- •11.Known or suspected impairment of immunologic function or any use of immunomodulatory medications since birth (e.g., systemic corticosteroids). Does not include topical and inhaled steroids.
- •12.Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- •13. Inability to comply with the study schedule and inability to attend all required study visits as outlined in the Study Flow Chart.
研究者
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