JPRN-jRCT2080224598
已完成
1 期
A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Prevention of Pneumococcal Infections
- 发起方
- MSD K.K.
- 入组人数
- 133
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Vaccination with V114-SC or V114-IM at approximately 3, 4, 5 and 12 to 15 months of age in Japanese healthy infants is generally well tolerated, with safety profiles generally comparable to PCV13-SC.
研究者
入排标准
入选标准
- •1\) Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator.
- •2\) Male or female 3 months of age inclusive (3 months of age to1 day prior to 4 months of age), at the time of obtaining the informed consent.
- •3\) Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
排除标准
- •1\)Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
- •2\)Has a known hypersensitivity to vaccines, any component of the pneumococcal conjugate vaccine or any diphtheria toxoid\-containing vaccine
- •3\)Has any contraindication to the PCV13 and/or diphtheria, tetanus, acellular pertussis, inactivated polio vaccine (DTaP\-IPV) being administered in the study (Refer to approved labeling for contraindication details on PCV13 and DTaPIPV vaccine).
- •4\)Has a recent febrile illness (axillary temperature \>\= 37\.5 degrees) occurring within 72 hours prior to receipt of study vaccine.
- •5\)Has a known or suspected impairment of immunological function.
- •6\)Has a history of congenital or acquired immunodeficiency.
- •7\)Has or his/her mother has a documented hepatitis B surface antigen \- positive test.
- •8\)Has a known functional or anatomic asplenia.
- •9\)Has failure to thrive based on the clinical judgement of the investigator.
- •10\)Has thrombocytopenia or a known coagulation disorder contraindicating intramuscular vaccination.
结局指标
主要结局
未指定
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