CTRI/2010/091/000008
Completed
Phase 1
A Phase I clinical trial to assess safety of the Pandemic influenza vaccine (Human, live attenuated) A (H1N1) 2009 of SIIL in Adults
Serum Institute of India Limited0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Serum Institute of India Limited
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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\. 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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
A clinical trial of SIIL's H1N1 vaccine (Inactivated) in Adults.CTRI/2010/091/000082Serum Institute of India Limited SII50
Completed
Not Applicable
A Study to Evaluate Safety and Pharmacokinetic Characteristics after Administration of the SJP003 in Healthy Male VolunteersEndocrine, nutritional and metabolic diseaseKCT0004019Samjin Pharmaceutical40
Completed
Phase 1
A trial to test the safety of a herbal formulatioCTRI/2018/02/011689SK Biolabs100
Completed
Phase 1
A trial to test the safety of a herbal drug.CTRI/2017/11/010617SK Biolabs100
Completed
Phase 1
A clinical trial to test the safety of a drugCTRI/2017/11/010540SK Biolabs100