EUCTR2005-002578-31-SK进行中（未招募）1 期
A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to healthy infants at 2, 4 & 6 months of age followed by a booster dose at 12 months of age
Sanofi Pasteur MSD S.N.C.0 个研究点目标入组 800 人开始时间: 2005年7月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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
- •1. Healthy infants of either gender,
- •2. 2 month-old infants (aged 57 to 90 days inclusive),
- •3. Infant born after 36 weeks of pregnancy and with a birth weight = 2.5 kg,
- •4. Consent form signed by parents or by the legal representative properly informed about the study,
- •5. Parents / legal representative able to understand the protocol requirements and to fill in the Diary Card.
- •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. Severe febrile illness and/or rectal temperature ³ 38.0°C at the time of vaccination,
- •2. Known history of diphtheria, tetanus, pertussis, H. influenzae type b, poliomyelitis, hepatitis B,
- •3. Infant known to be already immunised with one or more doses of vaccine against pertussis, tetanus, diphtheria, H. influenzae type b, poliomyelitis or hepatitis B,
- •4. Infant born from known HBs-Ag positive mother,
- •5. Known allergy to at least one of the vaccine components,
- •6. Known immune dysfunction (including subjects with HIV infection, sickle cell disease, asplenia, and other acquired immunodeficiency),
- •7. Infant who received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term (³ 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [³ 2mg/kg/day prednisone equivalent or ³ 20mg/day if weight more than 10kg]),
- •8. Infant who received within the previous 90 days or who will receive during the course of the study immunoglobulin or blood products
- •9. Infant with severe chronic disease,
- •10. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- •11. BCG vaccination in the previous 30 days,
- •12. Infant who, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements,
- •13. Participation in another clinical study within 30 days before study inclusion and/or during the whole study period.
研究者
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A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to healthy infants at 2, 4 & 6 months of age followed by a booster dose at 12 months of ageThe vaccine is indicated for primary and booster vaccination of children against six infectious diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis caused by 3 types of poliovirus (type 1,2 and 3), and invasive infections caused by Haemophilus influenza type b.EUCTR2005-002578-31-CZSanofi Pasteur MSD S.N.C.800
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