JPRN-jRCT2071200094已完成1 期
A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults.
Tanaka Yoshiyuki0 个研究点目标入组 102 人开始时间: 2021年1月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
研究概览
简要总结
The following key results were observed in pneumococcal vaccine-naive adults >=20 years of age: - Serotype-specific OPA GMTs and IgG GMCs following vaccination were generally higher in the V116 group than the PPSV23 group for the common serotypes. - Serotype-specific OPA GMTs and IgG GMCs following vaccination were higher in the V116 group than the PPSV23 group for the unique serotypes. - V116 was well tolerated with a safety profile that was generally comparable to that of PPSV23.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •is a healthy Japanese male or female >=20 years of age at time of randomization
- •- male participants must agree to be abstinent or use contraception during the study and for >=30 days after completing the study
- •- female participants must not be pregnant or breastfeeding, and is either:
- •- not a woman of childbearing potential (WOCBP) or
- •- a WOCBP who agrees to remain abstinent or use contraception during the study and for >=30 days after completing the study
排除标准
- •- has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
- •- has a known hypersensitivity to any vaccine components
- •- has impaired immunological function
- •- has a coagulation disorder
- •- had a recent febrile illness (axillary temperature >=37.5C or equivalent) within 72 hours before Day 1
- •- has a known malignancy that is progressing/requiring treatment
- •- has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
- •- has received systemic corticosteroids (prednisone equivalent of >=20 mg/day) for >=14 consecutive days and has not completed the regimen for >=30 days prior to Day 1
- •- is receiving immunosuppressive therapy
- •- has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
- •- has received any live vaccine from 30 days prior to Day 1
- •- has received a blood transfusion or blood products
- •- has participated in another clinical trial within 2 months of this study
- •- has clinically relevant drug or alcohol abuse
- •- has any condition that, in the opinion of the investigator, precludes participation in this study
研究者
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