PHASE 1 STUDY TO ASSESS THE IMMUNOGENICITY AND SAFETY OF INACTIVATED INFLUENZA VACCINE(H1N1)in healthy adult male human subjects.
- Registration Number
- CTRI/2010/091/000006
- Lead Sponsor
- Cadila Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1.Male subjects aged between 18 and 45 years (including both).
2.Subjects? weight within +/-15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
3.Ability to communicate effectively with study personnel.
4.Willingness to adhere to the protocol requirements.
5.Be able to give consent for participation in the trial.
6.Normal health as determined by personal medical history, clinical examination and laboratory examinations data during screening (within the clinically acceptable range).
1.History of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, egg proteins, neomycin or polymixin, or products containing mercury.
2.Subjects who are taking immunostimulant therapy (e.g. interferons) or immunosuppressant medications (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.).
3.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.
4.Subjects who have received immunoglobulins parenterally during the preceding 3 months.
5.Subjects who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days or individuals who have had suspected/confirmed pandemic influenza H1N1 infection.
6.Subjects having received influenza vaccine within the previous six months.
7.Subjects who have received any other vaccine in the preceding 3 months.
8.History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,immunological, dermatological, neurological, psychiatric disease or any other body system involvement.
9.History or presence of significant alcoholism or drug abuse within the past one-year.
10.History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products.
11.Difficulty with donating blood.
12.Blood pressure less than 100/60 mm Hg or more than 140/90 mm Hg.
13.Pulse less than 60/minute or more than 110/minute.
14.Febrile.
15.Any ECG abnormalities.
16.Any clinically significant abnormal laboratory values during screening.
17.Any clinically significant chest X-Ray findings during screening.
18.Major illness during 3 months before the screening period
19.Subjects who have participated in drug research studies within past 3 months.
20.Subjects who have donated one unit (350ml) of blood in the 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method