CTRI/2017/08/009204
Not yet recruiting
Phase 3
A prospective, randomized, two arm, singleblind, parallel, active controlled, multicentre,phase III clinical study to evaluate theimmunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P.(Tetravalent) of M/s Cadila HealthcareLimited in healthy children aged 6 months to17 years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Sponsor
- Cadila Healthcare Ltd
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy subject of either gender 6 months to 17 years of age
- •2\. Written informed consent from subjectâ??s either parent (mother / father) and
- •written assent from subjects more than 7 years of age
- •3\. Subjectâ??s either parent (mother / father) literate enough to fill the diary card
Exclusion Criteria
- •1\. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??Barré
- •syndrome or others) or any serious adverse event to any vaccine, egg,
- •chicken proteins, aminoglycoside antibiotics
- •2\. Subjects with history of administration of any influenza vaccine or subjects
- •with laboratory confirmed influenza in past
- •3\. Subjects with thrombocytopenia or any coagulation disorder, or subjects on
- •anticoagulation therapy
- •4\. Subjects with confirmed or suspected immunosuppressive or
- •immunodeficiency disorder; or subjects on any immunosuppressive or
- •immunostimulant therapy
Outcomes
Primary Outcomes
Not specified
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