CTRI/2018/05/014191已完成3 期
An Open-Label, Baseline-Controlled Study in Children and Adolescents Aged 6 Months â?? 17 Years to Assess the Immunogenicity, Reactogenicity and Safety of a Quadrivalent Influenza Vaccine in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
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
- •Inclusion Criteria:
- •1. Male and female subjects more than or equal to 6 months up to 17 years of age at the time of enrolment who the investigator believes that they and/or their parent(s)/LAR(s) 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 and/or subjectâ??s parent(s) or LAR(s) sign and date a written, informed consent form (ICF). An assent will also be obtained according to age appropriate specific regulations
- •4. Subjects who are 6-24 months of age at Day1 should have been born at full term of pregnancy (more than or equal to 37 weeks) and with a birth weight more than or equal to 2.5 kg
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-Barre syndrome, other progressive neurological diseases or seizures (subject who had a single uncomplicated febrile convulsion in the past could be included)
- •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 first study vaccination
- •5. Receipt of any vaccine (including routine childhood vaccines) 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 first 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 degree Celsius (measured by oral or rectal method, as applicable). 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 first 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 first 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. Ongoing aspirin therapy (to avoid cases of Reyeâ??s syndrome) for subjects
- •12. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known
- •13. 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.
- •14. Receipt of another investigational agent within 30 days prior to study vaccination, or planned exposure to an investigational or non-investigational product (pharmaceutical product or device) during the entire study period
- •15. Adolescents of childbearing potential with a positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study
- •16. Known drug or alcohol abuse
- •17. Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient hospitalization for at least 24 hours during the entire study period
研究者
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