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
- 试验地点
- 20
- 主要终点
- Efficacy:
研究概览
简要总结
A randomized, two-arm, observer-blind, parallel-group, active-controlled, multi-center clinical
study to evaluate the immunogenicity and safety of Influvac® Tetra compared to VaxiFlu-4 in
healthy adult and elderly subjects for 480 subjects in 4 groups in the age group above 18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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).
- •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.
- •The subjects sign and date a written, informed consent form (ICF).
- •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.
排除标准
- •History of adverse reaction or hypersensitivity to influenza vaccines or its components, incl.
- •egg, or chicken proteins.
- •History of Guillain-Barré syndrome, other progressive neurological diseases or seizures (subject who had a single uncomplicated febrile convulsion in the past could be included).
- •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).
- •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.
- •Receipt of any vaccine within the preceding 30 days or planned vaccination during the study within 30 days after any study vaccine administration.
- •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.
- •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.
- •Receipt of immunoglobulins or any blood products within the 3 months preceding the study vaccination and planned administration during the study period.
- •Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.
- •Being a solid organ or bone marrow/stem cell transplant recipient.
- •Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known.
- •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.
- •Pregnant or lactating female.
- •Known drug or alcohol abuse.
- •Planned surgery requiring a general anesthetic, or planned surgery requiring inpatient hospitalization for at least 24 hours during the entire study period.
- •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 study site involved in this study.
- •Any applicable contraindication as per the Prescribing information of VaxiFlu-4 by Zydus Cadilla.
结局指标
主要结局
Efficacy:
时间窗: End of the study
To describe and compare the immunogenicity of each vaccination group per age group (adults aged 18-60 years and elderly adults aged more than or equal to 61 years)
时间窗: End of the study
Safety:
时间窗: End of the study
To describe the safety (unsolicited AEs) and tolerability (reactogenicity) of each vaccination group in each age group (adults aged 18-60 years and elderly adults aged more than or equal to 61 years)
时间窗: End of the study
次要结局
- Safety objective - To describe the safety (unsolicited AEs) and tolerability (reactogenicity) of each vaccination group in each age group (adults aged 18-60 years and elderly adults aged ≥ 61 years)(end of the study)
研究者
研究点 (20)
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