An Open Label, Prospective, Multicentre, Single Arm, Single Treatment, Single Dose Post Marketing Surveillance Study to Evaluate the Safety and Tolerability of BCG Vaccine (Freeze â?? Dried) IP of GreenSignal Bio Pharma Pvt.Ltd. Chennai, India.

GreenSignal Bio Pharma Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年3月6日

试验速览

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•1. Cohort 1: Infants and children, below the age of 1 year (male and female, age not inclusive)
•Cohort 2; Adults and children above the age of 1 year (male and female, age inclusive)
•2. Clinically healthy subjects as evaluated by medical history, general and physical examination.
•3. Subjects who are known/ whose parents are known to be HIV negative.
•4. Subjects who are negative to the Tuberculin skin test
•5. Subjects who show no reason to be suspected of having tuberculosis.
•6. Subjects who have no scar relatable to previous BCG vaccination.
•7. Subjects / parents or LAR of subjects who are willing to provide informed consent for the participation in the study.

•1. Subjects who have previously been vaccinated with/ uncertain history of vaccination with BCG.
•2. Subjects who are sick, suffering from common cold or other conditions that compromise their immune system at the time of vaccination.
•3. Subjects with febrile conditions at the time of or 3 days prior to vaccination.
•4. Subjects with congenital immunodeficiency, leukemia or any malignant disease
•5. Subjects who are immunocompromised by known diagnosis of viral infections, cancer, surgery, transplants etc.
•6. Subjects who are on immunosuppressant inclusive of corticosteroids, alkylating agents, antimetabolites, on radiation treatment and anti-tuberculosis medications.
•7. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
•8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•9. Subjects who are known/ reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method.
•10. Subjects who in opinion of the investigator are deemed unfit to participate in the study.

发起方

GreenSignal Bio Pharma Pvt. Ltd.