Health Condition 1: Z23- Encounter for immunization
Conditions
Interventions
Intervention1: Inactivated Tetravalent Influenza vaccine (split virion) I.P. of M/s Cadila Healthcare Limited: Subjects enrolled in Cohort 1 (9 â?? 17 years) will receive 0.5 ml single dose.
Subjects
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subject of either gender 6 months to 17 years of age 2. Written informed consent from subjectâ??s either parent (mother / father) and written assent from subjects more than 7 years of age 3. Subjectâ??s either parent (mother / father) literate 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 vaccine, egg, chicken proteins, aminoglycoside antibiotics 2. Subjects with history of administration of any influenza vaccine 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 >= 37.5°C) 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 girls & female subjects of child bearing age 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 |
|---|---|
| Fulfilment of serologic criteria set by the USFDA for licensure of seasonal inactivated Influenza vaccines in pediatric population in Test groupTimepoint: 28 days after last vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres for all the four viral strains in the two groups, 28 days after last vaccinationTimepoint: 28 days after last vaccination;Seroconversion rate for all the four viral strains in the two groups, 28 days after last vaccinationTimepoint: 28 days after last vaccination;Seroprotection rate for all the four viral strains in the two groups, 28 days after last vaccinationTimepoint: 28 days after last vaccination | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Ltd
Outcome results
None listed