Multicentre, Post Marketing Surveillance study (PMS) to generate the safety data of Tetanus Vaccine (Adsorbed) I.P. in (0.5ml) single dose ampoule/ Ten doses (5ml vial) administered to children, adolescents and adults in either gender including pregnant women - Dano TT PMS

Dano Vaccines Biological Private limited0 个研究点目标入组 0 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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•Children, and adults in either gender including pregnant women aged 5 to 50 years of age (inclusive) who provide voluntary written informed consent by subject or its legal representatives. Adolescents (12 to 17 years of age) provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative
•Subject where Tetanus Vaccine (Adsorbed) I.P. is indicated
•Subjects willing to comply with protocol procedures
•Good clinical condition established by medical history and physical examination (with no acute disease, infection or high temperature >39.50 C, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination)

•Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
•Previous evidence of Tetanus
•History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics
•Subjects who had prior seizures, whether febrile or afebrile

发起方

Dano Vaccines Biological Private limited