None listed
Conditions
Interventions
Intervention1: Inactivated Influenza vaccine: Inactivated Influenza vaccine (split virion) I.P.
(Tetravalent) 0.5ml of M/s Cadila Healthcare Limited
0.5ml Dose to be given at Day 0 and 28
Control Inte
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy subject of either gender 6 months to 35 months of age at the time of enrolment 2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator 3. Informed consent from the parents of subjects. 4. Parents of subjects 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 (body 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. Participation in another clinical trial in the past 3 months 10. Have any condition that in opinion of the investigator would make the subject unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotection rate for all the four viral strains in the two groups at the end of the studyTimepoint: Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titres for all the four viral strains in the two groups at the end of the studyTimepoint: Day 56;Safety: 1. Solicited local and systemic adverse events reported during the study 2. Unsolicited adverse events reported during the study 3. Serious adverse events reported during the studyTimepoint: Day 0, Day 28 and Day 56;Seroconversion rate for all the four viral strains in the two groups at the end of studyTimepoint: Day 56 | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Limited
Outcome results
None listed