None listed
Conditions
Interventions
Intervention1: Trivalent Influenza Vaccine: Dose: 0.5 ml
Cohort 1: aged 6 months to 8 years
Study vaccine doses: 2 doses
Study duration: approximately 8 weeks,
Cohort 2: aged 9 to 17 years
Study v
Sponsors
Zydus Lifesciences Limited
Cliantha Research limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male or female aged 6 months to 17 years (completed months or years) at the time of screening. 2. Participant in good health condition based on clinical judgment of investigator as determined by medical history and physical examination. 3. Parents (of participants) literate enough to fill the participants diary. 4. Participants and their parents are likely to be available for follow-up for the entire duration of the study. 5. Availability of written informed consent from the parents (mother or father) of participants. Additionally, availability of assent from participants aged 7 to 17 years.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. History of Past history of hypersensitivity reaction, neurological disorder (Guillain Barre syndrome or others) or any serious adverse event to any vaccine, egg, chicken proteins, aminoglycoside antibiotics. 2. History of administration of any influenza vaccine in the past. 3. History of laboratory confirmed influenza in the last 1 year. 4. History of any respiratory infection requiring systemic antibiotic or antiviral therapy in the last 2 weeks. 5. Fever of any origin or infectious disorder of 3 days or more within the past month. 6. Febrile illness (body temperature Greater tha or Equal to 37.5 Degree Celsius) at the time of enrollment. 7. Any other vaccine administration within the last 30 days or planned to be administered during the study period. 8. Clinically significant systemic disorders, such as cardiovascular, respiratory, neurologic, gastro-intestinal, hepatic, renal, endocrine, hematological, immunological, metabolic, or major congenital. 9. Confirmed or suspected immunosuppressive or immunodeficiency disorder or on any immunosuppressive or immunostimulant therapy. 10. Known case of thrombocytopenia or any coagulation disorder, or on anticoagulation therapy. 11. Administered with blood, blood containing products, or immunoglobulins within the last 3 months or planned administration during the duration of the study. 12. Participation in any clinical trial in the last 3 months. 13. Any other reason, in the opinion of the investigator, due to which participation is not recommended.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of VaxiFlu of M/s. Zydus Lifesciences Ltd. In healthy children (6 months to 17 years)Timepoint: Cohort 1 (6 months to 8 years) : At Day 0 and 8 Weeks Cohort 2 (9 years to 17 years) : At Day 0 and 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety VaxiFlu of M/s. Zydus Lifesciences Ltd. In healthy children (6 months to 17 years)Timepoint: Cohort 1 (6 months to 8 years): At Day 0, 1 week, 4 weeks, 5 weeks and 8 weeks Cohort 2 (9 years to 17 years): At Day 0, 1 week and 4 weeks | — |
Countries
India
Contacts
Public ContactMr Mayur Vichhwawala
Cliantha Research Limited
Outcome results
None listed