Safety Study on BCG Vaccine of GreenSignal Bio Pharma Pvt Ltd.

Phase 4

Registration Number: CTRI/2023/02/049985

Lead Sponsor: GreenSignal Bio Pharma Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reactogenicity and Safety: Absence of any local and systemic adverse events up to 6 months following vaccination. <br/ ><br>2. Scar Formation: Normal Presentation/ Scar within acceptable limits, up to 6 months following vaccination. <br/ ><br>Timepoint: 1. Injection site abscess â?? Day 1 <br/ ><br>2. Injection site papule â?? Day 1, Day 45. <br/ ><br>3. Mild ulceration of injected site â?? Day 45 <br/ ><br>4. Lymphadenitis suppuration â?? Day 45, 6 months <br/ ><br>5. Skin lesions â?? Day 45, 6 months <br/ ><br>6. BCG lymphadenitis â?? 6 months <br/ ><br>7. Disseminated BCG Diseases â?? 6 months <br/ ><br>8. Osteitis/ Osteomyelitis â?? 6 months <br/ ><br>

Secondary Outcome Measures