Safety Surveillance Study of BCG vaccine

Phase 4

Completed

• Registration Number: CTRI/2017/09/009844
• Lead Sponsor: GreenSignal BioPharma Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-08
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3500

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 the opinion of the investigator are deemed unfit to participate in the study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reactogenicity and Safety: Normal presentation with no local and systemic adverse events <br/ ><br>2.Scar Formation: Normal Presentation at the site of vaccination. <br/ ><br>Timepoint: 1.Day 3, Day 45, 6 months, 12 months. <br/ ><br>2.Day 3, Day 45, 6 months, 12 months.

Secondary Outcome Measures

Name	Time	Method
Part I <br/ ><br>1.Injection site abscess <br/ ><br>2.Injection site papule <br/ ><br> <br/ ><br>Part I <br/ ><br>1.Injection Site Papule <br/ ><br>2.Mild Ulceration of Injection Site <br/ ><br>3.Lymphadenitis Suppuration <br/ ><br>4.Skin Lesions <br/ ><br> <br/ ><br> <br/ ><br>Part II <br/ ><br>1.Lymphadenitis Suppuration <br/ ><br>2.Skin Lesions <br/ ><br>3.BCG Lymphadenitis <br/ ><br>4.Disseminated BCG Diseases <br/ ><br>5.Osteitis/Osteomyelitis <br/ ><br> <br/ ><br>Part III <br/ ><br>1.Skin Lesions. <br/ ><br>2.BCG Lymphadenitis <br/ ><br>3.Disseminated BCG Diseases <br/ ><br>4.Osteitis/ Osteomyelitis <br/ ><br>Timepoint: Day 3, Day 45, 6 months, 12 months.