A prospective, randomized, two arm, parallel, activecontrolled, multicentre, phase III clinical study tocompare the immunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P. (Tetravalent) 0.5mlof M/s Cadila Healthcare Limited with Fluarix-Tetra ofM/s GlaxoSmithKline Pharmaceuticals Limited inhealthy children aged 6 to 35 months

Cadila Healthcare Limited0 个研究点目标入组 346 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•1. Healthy subject of either gender 6 months to 35 months of age at the time of enrolment
•2. Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
•3. Informed consent from the parents of subjects.
•4. Parents of subjects literate enough to fill the diary card

•1. Past history of hypersensitivity reaction, neurological disorder (Guillainâ??BarrÃ© 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
•5. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic,
•gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
•6. Subjects with febrile illness (body temperature >= 37.5Â°C) at the time of enrolment, or
•acute respiratory pathology or infections requiring systemic antibiotic or antiviral
•therapy during the preceding 7 days
•7. Subjects administered blood, blood containing products or immunoglobulins within
•the last 3 months or planned administration during the study
•8. Any other vaccine administration within the last 30 days or planned to be
•administered during the study period
•9. Participation in another clinical trial in the past 3 months
•10. Have any condition that in opinion of the investigator would make the subject
•unsuitable for participation in the study

发起方