CTRI/2009/091/000548已完成3 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 India
Wyeth Research Division of Wyeth Pharmaceuticals Inc0 个研究点目标入组 708 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 708
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
- •Aged 6 weeks (42 to 72 days) at time of enrollment.
- •Available for entire study period and whose parent/legal guardian can be reached by
- •Healthy infant as determined by medical history, physical examination, and judgment of
- •the investigator.
- •Parent/legal guardian must be able to complete all relevant study procedures during study
- •participation.
- •Weight of 3.5 kg or greater at the time of enrollment.
排除标准
- •Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus,
- •pertussis, or H influenzae type b (Hib) conjugate vaccines.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Contraindication to vaccination with pneumococcal conjugate, Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or measles vaccines.
- •Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- •Known or suspected immune deficiency or suppression.
- •History of culture-proven invasive disease caused by S pneumoniae.
- •Major known congenital malformation or serious chronic disorder.
- •Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due
- •to birth trauma such as Erb palsy.
- •Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- •Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- •Infant who is a direct descendant (child, grandchild) of the study site personnel.
研究者
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