A multicentric clinical trial of SIIL's H1N1 vaccine (Live) in Adults, Elderly and Children.

Phase 2

Completed

• Registration Number: CTRI/2010/091/000092
• Lead Sponsor: Serum Institute of India Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1.Normal healthy subjects of appropriate age. 2.Free of obvious health problems.

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,child with recurrent wheezing 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. History of Guillain-Barré Syndrome.10.Children and adolescents with H/o receiving aspirin therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SafetyTimepoint: Solicited reactions for 7 days for each dose, unsolicited reactions for 42 days and serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period

Secondary Outcome Measures

Name	Time	Method
immunogenicity assessmentTimepoint: On day 0, 21 and 42