Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Inactivated Trivalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited: Each subject will be given a single dose of 0.5ml vaccine given as a intramuscular injectio
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Serologic parameters set by the Committee for Medicinal Products for Human Use (CHMP) for influenza vaccines 2. Seroconversion rate for all the three viral strains in the two groups at the end of studyTimepoint: 21 days following vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres for all the three viral strains in the two groups at the end of the studyTimepoint: 21 days following vaccination;Local and systemic adverse events reported during the studyTimepoint: 42 days following vaccination;Seroprotection rate for all the three viral strains in the two groups at the end of the studyTimepoint: 21 days following vaccination | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Ltd
Outcome results
None listed