CTRI/2015/09/006208
Recruiting
Phase 2
A prospective, randomized, two arm, single blind, parallel, active controlled, multicentre, phase II/III clinical study to evaluate the immunogenicity and safety of Inactivated Trivalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited compared to marketed Inactivated Trivalent Influenza vaccine in healthy adults
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 348
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy subject of either gender \>\= 18 years of age
- •2\. Written informed consent from subjects
- •3\. Adult subjects literature enough to fill the diary card
Exclusion Criteria
- •1\. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??Barré syndrome or others) or any serious adverse event to any component of influenza vaccine, egg, chicken proteins, aminoglycoside antibiotics
- •2\. Subjects with history of administration of any influenza vaccine within the past 6 months or subjects with laboratory confirmed influenza in past
- •3\. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •4\. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •5\. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •6\. Subjects with febrile illness (temperature \>\= 100\.4oF) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
- •7\. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •8\. Any other vaccine administration within the last 30 days or planned to be administered during the study period
- •9\. Pregnant and lactating women \& female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •10\. Participation in another clinical trial in the past 3 months
Outcomes
Primary Outcomes
Not specified
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