Clinical validation of effectiveness of Immunace forte and Ultra D3 to improve the Safety Tolerability Immunogenicity of SARS CoV 2 Vaccine Against COVID 19 in Healthy Individuals - Nil

Meyer Organics Pvt Ltd0 个研究点目标入组 110 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Provides written informed consent prior to initiation of any study procedures.
•2.Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
•3.Agrees to the collection of venous blood per protocol.
•4.Male or non-pregnant female, > 18 years of age at time of enrollment.
•5.Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening.
•6.Women of childbearing potential must agree to use acceptable primary form of contraception
•7.In good health and with stable prescription for comorbidities if any.

•1.Confirmed pregnancy test either at screening or just prior to each vaccine administration.
•2.Female subject who is breastfeeding.
•3.Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation.
•4.Presence of self-reported or medically documented significant medical or psychiatric condition(s).
•5.Currently enrolled in or plans to participate in another clinical trial with an investigational agent or receiving similar medication that of investigational product for prophylaxis of COVID-19.
•6.Uncontrolled comorbidity.
•7.Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness.
•8.Received immunoglobulin and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
•9.Has any significant hematological disorder of coagulation.
•10.Has any chronic liver disease, including fatty liver.
•11.Has a history of alcohol or drugs abuse.
•12.History of documented infection of COVID-19.

发起方

Meyer Organics Pvt Ltd