EUCTR2016-004753-33-Outside-EU/EEA进行中（未招募）1 期
A Phase 3, Randomized, Multicenter, Observer-blinded, Noninferiority Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-licensed Quadrivalent Inactivated Comparator Influenza Virus Vaccine (Comparator QIV) in a Pediatric Population 6 Months Through 59 Months of Age
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Seqirus GmbH
- 入组人数
- 2,222
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
- •*Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation
- •*Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws
- •*Subject is in generally good health as per the Investigator’s medical judgment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2222
- •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
- •*History of allergic reactions to egg proteins or any components of the Study Vaccines;
- •*History of serious adverse reactions to any influenza vaccines;
- •*History of Guillain-Barré syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis;
- •*History of licensed or investigational influenza vaccination in the last 6 months;
- •*Clinical signs of active infection and/or an axillary temperature of = 99.5°F / (= 37.5 °C) on the day of vaccination or within 48 hours preceding vaccination.
- •*Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable *History of any seizures, with the exception of a single febrile seizure;
- •*Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C;
- •*Known or suspected congenital or acquired immunosuppressive conditions;
- •*Current or recent immunosuppressive or immunomodulatory therapy
- •*Current or medical history of malignant neoplasms;
- •*Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
- •*Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
- •*Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit
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