EUCTR2005-004772-21-ES进行中（未招募）1 期
A Phase 3, Randomized, Active-Controlled, Double-Blind, Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Spain. - Estudio fase III, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada según calendario vacunal en España
Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 619 人开始时间: 2006年6月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 619
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.Aged 2 months (42 to 98 days) at time of enrollment.
- •2.Available for entire study period and whose parent/legal guardian can be reached by telephone.
- •3.Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- •4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
- •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.Previous vaccination with licensed or investigational pneumococcal vaccine.
- •2.Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, MMR, or meningococcal vaccine.
- •3.A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •4.Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, MMR, pneumococcal, or meningococcal vaccines.
- •5.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •6.Known or suspected immune deficiency or suppression.
- •7.History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type b (Hib).
- •8.Major known congenital malformation or serious chronic disorder.
- •9.Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy.
- •10.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis).
- •11.Participation in another investigational study. Participation in purely observational studies is acceptable.
- •12.Infant who is a direct descendant (child, grandchild) of the study site personnel.
- •8. Major known congenital malformation or serious chronic disorder.
- •9. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb palsy.
- •10. Receipt of blood products or gamma-globulin (including Hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagisâ).
- •11. Participation in another investigational study. Participation in purely observational studies is acceptable.
- •12. Infant who is a direct descendant (child, grandchild) of the study site personnel.
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