Safety evaluation of a quadrivalent recombinant influenza vaccine (serotypes of 2021/2022) manufactured by Nivad Pharmed Salamat, open label, single arm, in volunteers aged = 18 years.

IVAD Pharmed Salamat0 个研究点目标入组 1,000 人开始时间: 待定最近更新: 2021年11月1日

适应症

试验速览

暂无简介。

•Aged = 18 years
•Able to provide written informed consent
•Subject is willing to comply with the study visits
•Healthy subjects or patients with stable concomitant diseases (the underlying disease is controlled and there is no need for hospitalization)

•Subject is currently participating or is planning to participate in another clinical trial in 1 month
•Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding
•Fever at the time of entry (temperature > 38 measured by remote thermometer)
•Having an active infection with clinical signs of Covid-19 such as fever or chills, cough, fatigue, headache, shortness of breath, sore throat, change in sense of smell or taste, or any other warning signs of infection within 72 hours before injection (If a person has already had the disease and has recovered, participation in the study is not prohibited.)
•History of severe allergy to any type of vaccine (anaphylactic shock)
•History of Guillain-Barré or other demyelinating diseases
•Covid-19 vaccination at least 2 weeks before participation
•Planning to receive Covid-19 vaccine for at least the next 2 weeks according to the national vaccination protocol

发起方

IVAD Pharmed Salamat