CTRI/2015/08/006074CompletedPhase 4
A Phase IV, Multi-centric clinical trial to systematically evaluate safety, reactogenicity and tolerability of Trivalent, Live Attenuated Seasonal Influenza vaccine of SIIL in large population
Serum Institute of India Ltd0 sites500 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1)Normal healthy subjects of >= 2 years at the time of screening.
- •2)Parents/legal guardians of subject (2-17 years) willing to give written informed consent and willing to comply with study protocol
- •3)The subjects (>=18 year) willing to give informed consent and willing to comply with study protocol.
- •4)The subjects (07-17 year) willing to give informed assent and willing to comply with study protocol.
- •5)Free of obvious health problems as established by medical history, and physical examination.
- •6)The participant should be the resident of study area.
Exclusion Criteria
- •1.Have a known allergy to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein).
- •2.Women with positive urine pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding or an unwillingness to undergo pregnancy testing.
- •3.The subject participating in other clinical trial or planned participation in another clinical trial during the present trial period
- •4.Subject with altered immune status or subject with chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of study vaccine.
- •5.Acute febrile illness or acute infectious disease or had acute respiratory illness needing antibiotics or antivirals in the previous 7 days
- •6.History of ongoing allergic rhinitis
- •7.A subject with asthma with recurrent wheezing
- •8.A children or adolescents (2-17 years of age) with history of receiving aspirin therapy or aspirin-containing therapy in the previous 7 days.
- •9.History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
- •10.History of Guillain-Barré Syndrome.
- •11.Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history, physical examination, which in the opinion of the investigator, might interfere with the study objectives
- •12.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or making it unlikely the subject could complete the protocol
Investigators
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