CTRI/2018/11/016324已完成4 期
A Phase 4, Open-Label, Single Arm, Multicenter Study to Describe the Safety of 13-Valent Pneumococcal Conjugate Vaccine in Children 6 to 17 Years of age in India
Pfizer Limited Subsidiary of Pfizer Inc0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Evidence of a personally signed and dated informed consent document (ICD) indicating that the subjectâ??s parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
- •Note: The subjectâ??s assent may also be required depending on local requirements.
- •2.Healthy male or female children 6 to 17 years of age at the time of vaccination.
- •3.Parent(s)/legal guardian(s)/child willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •4.Male subject not able to father children, male subject who is able to father children and willing to use a highly effective method of contraception, female subject not of childbearing potential, or female subject of childbearing potential and at risk for pregnancy who is willing to use a highly effective method of contraception.
- •Note: Female subjects of childbearing potential are defined as female subjects > 9 years old or have experienced menarche, whichever is earlier, and who are anatomically and functionally able to conceive.
排除标准
- •1.Child who is a family member of:
- •. Investigator site staff members directly involved in the conduct of the study;
- •. Site staff members otherwise supervised by the investigator;
- •. Pfizer employees directly involved in the conduct of the study.
- •2.Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in observational studies is permitted
- •3.History of severe adverse reaction, including hypersensitivity such as anaphylaxis, associated with a vaccine or vaccine component.
- •4.Contraindication to vaccination with pneumococcal conjugate vaccines (refer to local package insert)
- •5.Previous vaccination with licensed or investigational pneumococcal vaccine.
- •6.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •7.History of culture-proven invasive disease caused by S pneumoniae.
- •8.Major known congenital malformation or serious chronic disorder.
- •9.Known or suspected immune deficiency or suppression.
- •10.Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •11.Pregnant females; breastfeeding females; fertile males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study.
研究者
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