Safety Surveillance Study of BCG vaccine

Not Applicable

Completed

Conditions: No Condition. This is an observational study on subjects who are to routinely receive BCG vaccine as part of their vaccination program.

Registration Number: CTRI/2017/09/009844

Lead Sponsor: GreenSignal BioPharma Private Limited

Brief Summary: Open Label, Prospective,Multicentre, Single Arm, Single Treatment, Single Dose Post MarketingSurveillance Study to Evaluate the Safety AndTolerability of BCG Vaccine Freeze Dried IP Of GreenSignal Bio Pharma Ltd,Chennai, India. This is an OBSERVATIONAL STUDY only. No interventions are planned. The study is observed on subjects who routinely receive BCG vaccine as per of their immunisation program. The study is observed in three parts for a total duration of 12 months. The study population is split into 2 cohorts. **Cohort 1** **:** Infants and Children, below the age of 1 year (maleand female, age not inclusive)

**Cohort 2:** Adultsand Children above the age of 1 year (male and female, age inclusive) A total of 5000 subjects are to be enrolled and observed in this study. Reactogenicity, Safety and Scar Formation is observed as Efficacy End Points The following are observed as Safety End Points. **Part I** *(Visit 1-Day1 ; Visit 2-Day 3)*

1.     Injectionsite abscess

2.     Injectionsite papule

**Part I** *(Visit 3 â€“ Day 45)*

1.     InjectionSite Papule

2.     MildUlceration of Injection Site

3.     Lymphadenitis Suppuration

4.     Skin Lesions

**Part II** *(Visit 4 â€“ 6 Months)*

1.     Lymphadenitis Suppuration

2.     SkinLesions

3.     BCG Lymphadenitis

4.     DisseminatedBCG Diseases

5.     Osteitis/Osteomyelitis

**Part III** *(Visit 5 â€“ 12 months)*

1.     SkinLesions.

2.     BCG Lymphadenitis

3.     DisseminatedBCG Diseases

4. Osteitis/ Osteomyelitis

**Safety Monitoring**

**Mild Adverse events**

1. Injection Site Papule

2. Mild Ulceration

3. Scar

**Severe Adverse events**

1. Local Abscess

2. Keloid

3. Lymphadenitis Suppuration

4. Cutaneous Skin LEsions

5. osteitis/Osteomyelitis

6. Disseminated BCG Diseases.

7. Immune Reconstitution Syndrome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 5000

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	1.Day 3, Day 45, 6 months, 12 months. \| 2.Day 3, Day 45, 6 months, 12 months.
2.Scar Formation: Normal Presentation at the site of vaccination.	1.Day 3, Day 45, 6 months, 12 months. \| 2.Day 3, Day 45, 6 months, 12 months.

Secondary Outcome Measures

Name	Time	Method
Part I	1.Injection site abscess

Trial Locations

Locations (4): General Hospital, Tiptur Dt
🇮🇳
Tumkur, KARNATAKA, India
General Hospital, Tumkur Dt
🇮🇳
Tumkur, KARNATAKA, India
Government Hospital
🇮🇳
Kolar, KARNATAKA, India
Primary Health Centre
🇮🇳
Kolar, KARNATAKA, India
General Hospital, Tiptur Dt
🇮🇳Tumkur, KARNATAKA, India
Dr Guruswamy N T MD Paed
Principal investigator
9448988990
guru254888@gmail.com