EUCTR2016-004133-25-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 Seqirus Quadrivalent Inactivated Influenza Virus Vaccine (Seqirus QIV) with a US-Licensed 2015-2016 Quadrivalent Inactivated Comparator Influenza Vaccine (Comparator QIV) in a Pediatric Population Aged 5 Through 17 Years 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
- •* Males or females 5 through 17 years of age on the day of first study vaccination.
- •* 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. Participant assent will also be obtained if required.
- •* If applicable, females of childbearing potential” (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine.
- •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.
- •* History of licensed or investigational influenza vaccination in the last 6 months.
- •* Clinical signs of active infection and/or an oral temperature of = 100°F (37.8°C) on the day of planned Study Vaccine administration 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 (such as illness exacerbations) within the preceding 30 days.
- •* 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, as follows:
- •* Chronic or long-term systemic corticosteroids: = 0.125 mg/kg/day of oral prednisolone or equivalent daily;
- •* Sporadic systemic corticosteroids: = 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination;
- •* Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination.
- •Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable.
- •* Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study.
- •* Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period.
- •* Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
- •* Pregnant or lactating females.
研究者
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