None listed
Conditions
Interventions
Intervention1: Inactivated Influenza Vaccine (Whole Virion) IP(Pandemic Influenza (H1N1) 2009 Monovalent Vaccine): Single I.M. dose of the vaccine (0.5 ml) contains more than or equal to 15 mcg of
hae
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical examination (vital signs recording) of subjects at check-in, check-out, day 3, day 7, day 14, day 21 and additionally on day 42 and monitoring of subjects for local adverse reactions (soreness,redness, swelling, pain, tenderness, induration and ecchymosis) and fever (38 degree celsius). Vital signs will be measured and recorded during subject check-in, prior to administration of dose, 1.00, 2.00, 4.00, and 12.00 hours post dose and at check-out.Timepoint: 1.Clinical examination will be done at the time of check-in, check-out, day 3, day 7, day 14, day 21 and additionally on day 42.Vital signs like BP, radial pulse and oral temperature will be measured and recorded during subjectcheck-in, prior to administration of dose, 1.00, 2.00, 4.00, and 12.00 hours after administration of dose and at check-out. 2. An antihaemagglutinin antibody titre would be assessed at pre-dose and on day 21 following drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical examination (vital signs monitoring) of subjects for systemic reactions and neurological signs of Guillain Barre syndrome, b)ECG, c)Laboratory assessments and Hematology, liver function, renal function d) Increase in Geometric mean titre 2.5 fold f) proportion of subjects achieving an HI titre â?¥ 1:40 should be 70%Timepoint: 1. Clinical examinations including vital signs will be done at check-in, days 3,7,14,21 and additionally day 42. ECG at the time of screening. Laboratory assessments at the time of screening, hematology, renal function and liver function tests will be done at check-out (day 1),days 3,7,14 and 21 of the study. | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Cadila Healthcare Limited
Outcome results
None listed