None listed
Conditions
Interventions
Intervention1: Live attenuated Influenza A (H1N1) virus vaccine: Single dose of 0.5 ml, Intranasal
Control Intervention1: Placebo: Single dose of 0.5 ml, Intranasal
Sponsors
Serum Institute of India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Normal healthy subjects of 18-49 years age at the time of screening. 2)Free of obvious health problems
Exclusion criteria
Exclusion criteria: 1.Have a known allergy to eggs or other components of the vaccine 2.Pregnancy 3. Participating in other clinical trial during the present trial period 4. Altered immune status 5. Acute febrile illness or acute infectious disease or had acute respiratory illness in the previous 7 days. 6. Subject with nasal pathology, History of allergic rhinitis, asthma or administration of any intranasal medication. 7. History of a previous severe allergic reaction. 8. History of H1N1 Influenza infection or any influenza vaccination. 9. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen.10. History of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety- Solicited, unsolicited, serious adverse events and New onsent Chronic Medical conditionTimepoint: Solicited adverse reaction for day 7 and unsolicited, serious adverse events and New onsent Chronic Medical conditions through out subject participation period. period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal immunity and viral replicationTimepoint: Till day 7 | — |
Countries
India
Contacts
Public ContactDr Prasad Kulkarni
Serum Institute of India Ltd
Outcome results
None listed