EUCTR2006-005445-11-FI进行中（未招募）不适用
An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C conjugate (MCC) vaccine in healthy infants
Sanofi Pasteur MSD S.N.C.0 个研究点开始时间: 2006年11月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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, aged from 6 weeks through full 7 weeks (= 42 to < 56 days; 6th week birthday to one day prior to the 8th week birthday),
- •2. Consent form signed by at least one parent or by the legal representative properly informed about the study,
- •3. Parent(s) / 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. History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
- •2. Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
- •3. Known or suspected impairment of immunological function,
- •4. Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
- •5. Prior administration of any rotavirus vaccine,
- •6. Prior administration of any vaccine within the 28 days prior to randomisation,
- •7. Fever (rectal temperature =38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
- •8. History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
- •9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
- •10. Clinical evidence of active gastrointestinal illness. Note: Infants with gastroesophageal reflux disease may participate in the study as long as the gastroesophageal reflux disease is well controlled with or without medication,
- •11. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
- •12. Infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalised malignancy, chronic renal failure, meningitis, organ or bone marrow transplantation, or with those receiving anti-cancer drugs or immunosuppressive chemotherapy, including long-term systemic corticosteroids,
- •13. Prior receipt of a blood transfusion or blood products, including immunoglobulins,
- •14. Participation in another clinical study before or during the current clinical study,
- •15. Any infant who cannot be adequately followed for safety by a contact visit,
- •16. Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
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