AN OPEN-LABEL, SINGLE-TREATMENT, SINGLE-PERIOD, SINGLE DOSE, CLINICAL PHASE 1 STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF INACTIVATED TRIVALENT INFLUENZA VACCINE (SPLIT VIRION) OF M/s CADILA HEALTHCARE LTD., INDIA IN HEALTHY, ADULT, MALE, HUMAN SUBJECTS.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd., India given Intramuscularly in healthy adult male human subjects.
研究概览
简要总结
This is an an open-label, single-treatment, single-period, single dose, phase 1 clinical study in healthy, adult, male, human subjects.
Objective of this study is to assess the safety and tolerability of Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd., India given Intramuscularly in healthy adult male human subjects.
The subjects will be administered a single Intramuscular (I.M.) dose of 0.5 ml of the vaccine into the Upper arm. The subjects will be housed at the clinical facility from not less than 11 hours pre-dose till 24-hour post-dose during the study period.
Blood sample for safety purpose will be collected on day 21 during the study through disposable syringes and needles. Vital signs like oral temperature, sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior to administration of dose, 1.00, 2.00, 6.00 and 12.00 hours after administration of dose and at check-out.
Clinical examination of the subjects will be done at the time of check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 during the study and subjects will be monitored specifically for local adverse reactions (soreness, redness, swelling, pain, tenderness, induration and ecchymosis), systemic reactions (headache, muscle ache, fever [≥38 0C], nausea, vomiting, diarrhea, shivering, fatigue and malaise).
ECG will be recorded at the time of screening. Subjects will be questioned for well being at the time of clinical examinations and recording of vital signs.
Laboratory assessments: Hematology, serum chemistry, serology, Uric Acid and urine analysis will be done at the time of screening. Hematology, liver function and renal function tests will also be done on Day 21.
Urine test for drug of abuse and alcohol breath test will be performed at the time of check in during study period.
The data will be analyzed for demographics and safety parameters. Descriptive statistics will be provided for demographics, vitals and other safety assessments. Paired t test will be used to check the significance of pre and post data of the clinical laboratory parameters. Evaluation of safety and tolerability (adverse events, vital signs, and clinical laboratory parameters) will be done on the basis of clinical significant changes observed in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects’ weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •Ability to communicate effectively with study personnel.
- •Willingness to adhere to the protocol requirements.
- •Be able to give consent for participation in the trial.
- •Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range).
排除标准
- •History of anaphylaxis or serious reactions to vaccines, egg proteins, gelatin or gelatin containing product.
- •Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •Subjects who are known to be suffering from diseases which can affect immune competence e.g. diabetes, immunodeficiency disorders or known to be HIV positive.
- •Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •Subjects who have received any vaccine in the preceding 6 months.
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
- •History or presence of significant alcoholism or drug abuse within the past one-year.
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product.
- •Difficulty with donating blood.
- •Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90(Systolic/diastolic) mm Hg. -Pulse less than 60/minute or more than 110/minute.
- •Any ECG abnormalities.
- •Any clinically significant abnormal laboratory values during screening.
- •Any clinically significant chest X-Ray findings during screening.
- •Major illness during 3 months before the screening period -Subjects who have participated in drug research studies within past 3 months.
- •Also subjects will be assessed for alcohol and drug of abuse consumption at the time of check in during the study.
- •Subjects who are found positive in alcohol breathe test and urine test for drug of abuse, will not be enrolled in the study.
结局指标
主要结局
To assess the safety and tolerability of Inactivated Trivalent Influenza Vaccine (Split Virion) of M/s. Cadila Healthcare Ltd., India given Intramuscularly in healthy adult male human subjects.
时间窗: Vital signs like oral temperature, sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior to administration of dose, 1.00, 2.00, 6.00 and 12.00 hours after administration of dose and at check-out. | Clinical examination of the subjects will be done at the time of check-in, checkout (Day 01), Day 3, Day 7, Day 14, Day 21 and Day 42 during the study
次要结局
- Not applicable(NA)