EUCTR2005-003508-12-DE进行中（未招募）不适用
Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children - Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children
Merck and Co., Inc.0 个研究点目标入组 522 人开始时间: 2005年12月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 522
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
- •Infants in good health, 6 to 12 weeks of age.
- •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
- •History of congenital abdominal disorders, intussusception, or abdominal surgery. Known or suspected impairment of immunological function. Known hypersensitivity to any component of the rotavirus vaccine. Prior administration of any rotavirus vaccine. Known hypersensitivity or contraindication to any component of the INFANRIX™ hexa vaccine. Any infant born from a known HBsAg-positive mother. Prior administration of any oral polio vaccine. Receipt of one or more doses of inactivated poliovirus vaccine, diphtheria, tetanus and acellular pertussis vaccine, diphtheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination. Fever, with a rectal temperature greater than/equal to 38.1 degrees C (great than/equal to 100.5 degrees F) at the time of immunization. History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive. Clinical evidence of active gastrointestinal illness. Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. Infants residing in a household with an immunocompromised person. Prior receipt of a blood transfusion or blood products. History of seizure disorders or prior history of seizure disorders with or without fever.
研究者
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Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children - Concomitant Use of RotaTeq™ and HEXAVAC® in Healthy ChildreEUCTR2005-003508-12-ATMerck Sharp & Dohme GesmbH
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Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Infants. - Concomitant Use of RotaTeq™ and HEXAVAC® in Healthy ChildreRotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g., G9).MedDRA version: 10Level: LLTClassification code 10017913EUCTR2005-003508-12-BEMerck Sharp & Dohme BV522
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