A clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults.

Phase 1

Completed

• Registration Number: CTRI/2010/091/000082
• Lead Sponsor: Serum Institute of India Limited SII

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: 50

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

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. Acute febrile illness or acute infectious disease 5.History of a previous severe allergic reaction. 6. History of H1N1 Influenza infection or any influenza vaccination. 7. Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen. 8.History of Guillain-Barré Syndrome. 9. Known history of a bleeding disorder

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety- Solicited,<br>Unsolicited, Serious<br>Adverse Events And New<br>Onsent Chronic Medical<br>ConditionTimepoint: Solicited Adverse Reaction For Day 7<br>And Unsolicited, Serious Adverse Events<br>And New Onsent Chronic Medical<br>Conditions Through Out Subject<br>Participation Period.

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil