CTRI/2018/02/012222已完成3 期
A Randomized, Two-arm, Observer-blind, Parallel-group, Activecontrolled,Multi-center Clinical Study to Evaluate theImmunogenicity and Safety of Influvac® Tetra compared toVaxiFlu-4 in Healthy Adult and Elderly Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
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
- •1. Male and female subjects more than or equal to 18 years of age at the time of enrolment who the investigator
- •believes that they can and will comply with the requirements of the protocol (e.g. completion
- •of the subject diaries, return for follow-up visits and be available for telephone contacts).
- •2. Subjects in stable health determined from medical history, physical examination and clinical
- •judgment of the Investigator. Subjects may have underlying illnesses as long as their
- •symptoms/signs are controlled. If at the time of enrolment the subject has been on regular
- •prescribed medication for at least 3 months for a preexisting condition, the dose must have
- •been stable for at least 3 months preceding study vaccination.
- •3. The subjects sign and date a written, informed consent form (ICF).
- •4. Females of childbearing potential may be enrolled in the study, if the subject:
- •a. has practiced highly effective contraception for 30 days prior to vaccination, and
- •b. has a negative urine pregnancy test on the day of vaccination, and
- •c. has agreed to continue highly effective contraception during the entire study period.
排除标准
- •1. History of adverse reaction or hypersensitivity to influenza vaccines or its components,
- •incl. egg, or chicken proteins.
- •2. History of Guillain-Barré syndrome, other progressive neurological diseases or seizures
- •(subject who had a single uncomplicated febrile convulsion in the past could be
- •3. Any confirmed, acute or historic (within 6 months prior to enrollment), or suspected
- •immunosuppressive or immunodeficient condition based on medical history and physical
- •examination (no laboratory testing required).
- •4. Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational)
- •or laboratory-confirmed influenza infection in the 6 months preceding the study
- •vaccination.
- •5. Receipt of any vaccine within the preceding 30 days or planned vaccination during the
- •study within 30 days after any study vaccine administration.
- •6. Having fever and/or acute disease or infection on the day of study vaccination (enrolment
- •can be deferred for up to 2 weeks provided subject remains otherwise eligible). Fever is
- •defined as a body temperature more than or equal to 38.0 oC (measured by oral method). Subjects with a
- •minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may
- •be enrolled at the discretion of the investigator.
- •7. Chronic systemic administration (defined as more than 14 days) of immunosuppressant
- •or immune-modifying medication (such as corticosteroids and monoclonal antibodies)
- •during 3 months prior to the study vaccination or planned use thereof during the study.Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal
- •sprays), within the dosage noted on the product label, is allowed.
- •8. Receipt of immunoglobulins or any blood products within the 3 months preceding the
- •study vaccination and planned administration during the study period.
- •9. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months
- •before the day of study vaccination.
- •10. Being a solid organ or bone marrow/stem cell transplant recipient.
- •11. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to
- •entering this study if the treatment arm is not known.
- •12. Any condition that in the opinion of the Investigator would pose a health risk to the
- •subject if enrolled or could interfere with the evaluation of the vaccine including (but not
- •limited to) bleeding disorder, acute or progressive clinically-significant pulmonary,
- •cardiovascular, hepatic or renal functional abnormality, as determined by medical history
- •and/or physical examination. Receipt of another investigational agent within 30 days
- •prior to study vaccination, or planned exposure to an investigational or noninvestigational
- •product (pharmaceutical product or device) during the entire study period.
- •14. Pregnant or lactating female.
- •15. Known drug or alcohol abuse.
- •16. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient
- •hospitalization for at least 24 hours during the entire study period.
- •17. Being an employee (or family member of the employee) of the Sponsor/ Contract
- •Research Organization conducting this study or (family members of) personnel of the
研究者
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