None listed
Conditions
Interventions
Intervention1: Formulationa A of Live attenuated Seasonal trivalent Influenza virus vaccine: on Day 0, Single dose of 0.5ml by Intranasal route, Influenza vaccine containing Dose of Not less than log
Sponsors
Serum Institute of India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy subjects of appropriate age (pediatric 2-17 years; adult 18-49 years; elderly >= 50 years 2.Free of obvious health problems as established by medical history, and physical examination. 3. A woman of child bearing age potential must agree not to become pregnant and a man must agree not to conceive a child during his/her study participation.
Exclusion criteria
Exclusion criteria: 1. Confirmed/suspected influenza infection or any influenza vaccination.2. Have a known allergy to eggs. 3. Pregnancy and breastfeeding women 4. Subject participating in other clinical trial 5. Altered immune status. 6. Acute febrile illness or acute infectious disease. 7. Any nasal pathology. 8. Asthma with recurrent wheezing. 9. History of allergic reaction. 10. History of serious chronic illness. 11. H/o Guillain-Barré Syndrome. 12. children or adolescents receiving aspirin therapy in the previous 7 days. 13. Major congenital defects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety- Solicited local and systemic reactions, unsolicited adverse events, serious adverse events and new onset medical conditionsTimepoint: Day 0, Day 7, Day 21 and Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity (Seroconversion)Timepoint: Day 7 and Day 21 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd, Pune
Outcome results
None listed