EUCTR2009-017304-88-Outside-EU/EEA进行中（未招募）不适用
A Phase 3, Open Label Trial Evaluating the Safety,Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Healthy Children Aged 15 Months to 17 Years in the United States
Wyeth Research division of Wyeth Pharmaceuticals Inc.0 个研究点目标入组 1,200 人开始时间: 2015年4月10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
- 1,200
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
- •All subjects
- •1.Male or female subject between the ages of greater than (>)15 months and less than (<)18 years at time of enrollment.
- •2.Child is available for the entire study period and his/her parent/legal guardian can be reached by telephone.
- •3.Child is determined to be in good health by medical history, physical examination, and judgment of the investigator.
- •4.Parent/legal guardian must be able and willing to comply with all study procedures.
- •Groups 1 (subjects aged less than <15 months to >2 years), Group 2 (subjects aged greater than or equal to [>=] 2 to <5 years) and Group 3 (>=5 to <10 years) only
- •5.Written documentation endorsed by a health professional showing vaccination with at least 3 doses of Prevnar in children aged <5 years or at least 1 dose of Prevnar in children aged =5 to <10 years. The last dose of Prevnar must have been received at least 56 days before study entry.
- •Group 4 (subjects aged >=10 to <18 years) only
- •6.Negative urine pregnancy test for female subjects who are menstruating.
- •All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of hormonal and/or nonhormonal contraception for 3 months after the vaccination. A subject is biologically capable of having children if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1200
- •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
- •All subjects
- •1.Child had a previous anaphylactic reaction to any vaccine or vaccine-related component.
- •2.Contraindication to vaccination with pneumococcal conjugate vaccine.
- •3.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •4.History of culture-proven invasive disease caused by S pneumoniae.
- •5.Major known congenital malformation or serious chronic disorder.
- •6.Significant neurological disorder or history of seizure (excluding simple febrile seizure), or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
- •7.Receipt of blood products or gamma-globulin.
- •8.Known or suspected immune deficiency or suppression.
- •9.Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- •10.Child is a direct descendant (child or grandchild) of site study personnel.
- •11.Subject has been previously vaccinated with 23-valent pneumococcal polysaccharide.
- •Group 4 only
- •12.Children aged =10 years to <18 years (group 4) who have previously been vaccinated with Prevnar or any other pneumococcal vaccine.
- •13.Pregnant or breastfeeding adolescent females.
研究者
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